Effect of Spinning Babies® on Labor Progression and Cesarean Delivery Rates: Protocol for an Open-Label, Two-Arm, Parallel Randomized Controlled Trial

Effect of Spinning Babies® on Labor Progression and Cesarean Delivery Rates: Protocol for an Open-Label, Two-Arm, Parallel Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Effect of Spinning Babies® on Labor Progression and Cesarean Delivery Rates: Protocol for an Open-Label, Two-Arm, Parallel Randomized Controlled Trial Soliane Scapin, Maíra Takemoto, Roberta Costa This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8960766/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 3 You are reading this latest preprint version Abstract Background Cesarean section rates remain high worldwide, especially in Brazil, where they far exceed international recommendations. Arrest of labor progression is one of the main indications for intrapartum cesarean delivery and is frequently related to challenges in fetal descent, rotation, and positioning within the maternal pelvis. Maternal movement and positioning during labor are recognized strategies to support physiological labor progression. The Spinning Babies’s® approach is a non-invasive method based on intentional movements and positioning, developed to facilitate fetal rotation and descent. Despite its widespread use in clinical practice, to date there are no randomized controlled trials evaluating the effectiveness of this approach, highlighting a relevant gap in scientific knowledge. This study aims to assess the effectiveness of the Spinning Babies® approach on labor progression and obstetric outcomes compared with standard intrapartum care. Methods This is an open-label, single-center, parallel, two-arm randomized controlled trial conducted in a large public university maternity hospital in Southern Brazil. Nulliparous women aged 18 years or older, at term, with singleton pregnancies, cephalic fetal presentation, and fetuses located in the midpelvis during spontaneous labor will be included. Participants will be randomized in a 1:1 ratio to receive either the Spinning Babies® intervention or standard care. The intervention consists of applying Spinning Babies® positioning and movement exercises every two hours while the fetal presentation remains in the midpelvis. The primary outcome is total labor duration, measured from the diagnosis of active labor to birth. Secondary outcomes include measures of labor progression, use of obstetric interventions, mode of birth, and neonatal outcomes. Analyses will follow the intention-to-treat principle. Discussion This trial was designed to address the lack of randomized evidence regarding the Spinning Babies® approach, contributing to knowledge improvement of non-invasive strategies to support labor progression. By evaluating this intervention within the context of routine midwifery-led care, the study may inform evidence-based intrapartum practices and also may contribute to the reduction of unnecessary obstetric interventions such as cesarean sections. Trial registration : Brazilian Clinical Trials Registry (REBEC), identifier RBR-42pbbqq, prospectively registered. Pregnant People Obstetrics Labor obstetric Natural childbirth Obstetric Nursing Patient Positioning Labor Presentation Figures Figure 1 BACKGROUND The global rate of cesarean sections (CS) has risen substantially, reaching 21.1% of all live births. 1 Brazil has the second-highest CS rate in the world, with 57% of births occurring by CS in 2021. 2 Preliminary findings from the Nascer no Brasil II study indicate that this percentage is now approaching 60%. 3 This scenario is associated with unfavorable maternal and neonatal outcomes, including higher risks of prematurity, postpartum hemorrhage, and infection. 4 – 7 For these reasons, the World Health Organization (WHO) recommends that CS rates remain within 10% to 15% and that surgical births should only be performed when clear clinical indications are present. 5 Among the main indications for CS, labor dystocia or arrest of labor progression is particularly notable. 4 However, the frequency of this diagnosis may reflect limitations in the assessment and management of challenges related to fetal descent, rotation, and position within the maternal pelvis. Given these challenges and the need to reduce unnecessary obstetric interventions, national and international initiatives have sought to promote vaginal birth. Maternal positioning and movement during labor are recognized as an effective strategy to support this outcome. Evidence suggests that movements—whether spontaneous or guided (intentional) —improve maternal and fetal circulation, facilitate fetal positioning, and increase the likelihood of vaginal birth. 8 – 10 Within this context, the Spinning Babies® approach has emerged as a globally recognized non-invasive approach that aims to support labor progression through intentional movement combined with techniques to add balance and suppleness in the soft tissues that may affect fetal rotation and descent. 11 – 12 Developed by midwife Gail Tully, this innovative approach integrates principles of neurophysiology and biomechanics to promote balance, increase space and reduce tensions within the pelvis and surrounding structures such as muscles, ligaments, and fascia. 11 – 12 Spinning Babies® primary goal is to assist the fetus in completing physiological rotations and descending through the pelvis, using targeted postures and exercises that match the fetal station and position. 11 – 14 Despite its widespread disseminated positive anecdotal reports and the growing body of observational data indicating its potential benefits, the Spinning Babies® approach still lacks randomized clinical trials (RCT) to establish their efficacy within more controlled methodological settings. To date, available evidence remains limited. One nonexperimental quantitative study found that 84% of women using Spinning Babies® had vaginal birth, compared with 77% of women in the standard care group, which suggests potential benefits in reducing CS. 14 Other studies also observed similar results, often performing before-and-after analysis. 15 – 16 To address this gap of comparative studies, we will conduct an open-label, single-site, parallel, two-arm RCT to assess the effectiveness of Spinning Babies® compared with standard care to assist labor progression among women with spontaneous labor of a singleton cephalic fetus in the midpelvis (DeLee stations − 1, 0 or + 1). Our hypothesis is that the approach will contribute to decrease labor length as well as obstetric intervention rates. METHOD The aim, design, and setting of the study The aim of this study is to evaluate the effectiveness of the Spinning Babies® approach on labor progression and obstetric outcomes compared with standard intrapartum care. This is a Brazilian open-label, single-center, parallel, two-arm randomized controlled trial conducted in the maternity unit of a large public university hospital in Southern Brazil. The maternity unit is fully funded by the Brazilian Public Healthcare System (Sistema Único de Saúde – SUS) and serves as a referral center for both low- and high-risk pregnancies. In 2023, the unit recorded 3,296 births, of which 2,103 (63.8%) were vaginal births and 1,193 (36.2%) were cesarean sections. Low-risk births are monitored and attended primarily by nurse midwives. Recruitment and data collection began on July 2, 2025, and are expected to be completed by the end of February 2026 or upon reaching the target sample size. The characteristics of participants The study population includes all pregnant individuals that meet the institutional criteria to be primarily cared for by nurse midwives in accordance with the local protocol, which comprises the following criteria: ● Pregnant individuals classified during prenatal care as low-risk; ● Pregnant individuals classified as intermediate-risk with clinical stability, including the following conditions: ○ Hypothyroidism or hyperthyroidism with adequate clinical and laboratory control; ○ Gestational diabetes mellitus controlled by diet, without fetal repercussions; ○ Generalized anxiety disorder under good control; ○ History of adequately treated syphilis; ○ History of treated toxoplasmosis; ○ Isolated episode of elevated blood pressure below 160/100 mmHg, without symptoms or laboratory abnormalities, and normotensive at the time of admission; ○ Group B Streptococcus positive or unknown status, with prescribed antibiotic prophylaxis; ● Gestational age ≥ 37 weeks, with a singleton fetus in cephalic presentation; ● Active labor (cervical dilation > 5 cm, accompanied by three to four contractions every 10 minutes); ● Fetal heart rate within the normal range (110–160 bpm); ● Absence of thick meconium-stained amniotic fluid; ● Parturient in good overall condition: afebrile, eupneic, normotensive, and with normal pulmonary and cardiac auscultation; ● Body mass index (BMI) ≤ 35. The study sample will consist of pregnant individuals who meet all of the inclusion and none of the exclusion criteria described below. ● Pregnant individuals aged 18 years or older; ● Term pregnancy: gestational age ≥ 37 weeks; ● Singleton pregnancy with a fetus in cephalic presentation; ● Nulliparous pregnant individuals with intact or ruptured membranes in spontaneous labor: Labor is defined as the presence of at least three regular uterine contractions within a 10-minute period and a minimum cervical dilation of 5 centimeters; 17 ● Pregnant individuals with fetal presentation at the midpelvis. For the purposes of this study, midpelvis is defined as DeLee stations − 1/0/+1, as described within the Spinning Babies® approach. The exclusion criteria for the study will be: ● Pregnant individuals with a history of practicing Spinning Babies® during the current pregnancy (to reduce the likelihood of co-intervention bias or unintentional cross-over); ● Pregnant individuals accompanied by doulas (to reduce the likelihood of co-intervention bias or unintentional cross-over); ● Pregnant individuals who have undergone any type of pharmacological induction; ● Pregnant individuals who cannot speak or understand Portuguese well; ● Pregnant individuals with any physical limitation or contraindication that prevents them from performing Spinning Babies® techniques. The sole discontinuation criterion is withdrawal from participation in the study or withdrawal of consent. Pregnant women who meet all eligibility criteria are invited to participate in the study. Eligible participants receive the informed consent form for reading and signature and are enrolled only after written informed consent has been obtained. Description of processes, interventions, and comparisons Given the absence of previous RCT evaluating Spinning Babies® to inform sample size calculation, the required sample was estimated based on the clinically relevant difference in the duration of labor (in minutes) associated with intentional positioning interventions. For this calculation, results from clinical trials investigating the use of a peanut ball were used as a reference. The mean difference of 80 minutes between two groups was adopted, based on the findings reported by Grenvik 18 for the first stage of labor as a proxy for the expected effect size. Assuming a common standard deviation of 120 minutes, a type I error risk of 5%, a type II error risk of 20%, and applying a two-tailed test with equal allocation between groups, the minimum required sample size was estimated at 37 participants per group (intervention and control). Participants are randomized in a 1:1 ratio to either the intervention group (Spinning Babies®) or the control group (standard care). The randomization sequence is generated in advance by an independent team of statisticians using block randomization with fixed blocks of four to ensure balance between groups throughout the recruitment period. The statistician generating the random sequence had no role in recruitment or intervention application. Allocation concealment is ensured through the use of sequentially numbered, opaque, sealed envelopes containing cards indicating group assignment (intervention or control). The envelopes are prepared in advance by a researcher not involved in participant recruitment or clinical care. After eligibility is confirmed and written informed consent is obtained, the attending nurse midwife opens the next envelope in sequence to determine group allocation. To minimize the risk of contamination between groups, participants are accommodated in individual suites with no physical contact between them. Following allocation, group assignment is identified by the responsible nurse midwife using a tag displayed on the nursing station board, where all admitted patients are listed. The same identification procedure is applied to the medical staff board located in the physicians’ room and on the participant’s room door, ensuring clear communication among the care teams involved while preserving allocation concealment prior to enrollment. Prior to study initiation, all participating nurse midwives complete a structured 13-hour official Spinning Babies® training program. In addition, a 4-hour refresher training session was conducted immediately before the start of participant recruitment to reinforce intervention protocols and standardize procedures. Throughout the data collection period, the research team remains available to address questions, clarify procedures, and provide ongoing support, thereby ensuring protocol adherence, consistency in intervention delivery, and fidelity to the study design. Intervention Group Eligible participants allocated to the intervention group receive the practices proposed by the Spinning Babies® protocol, which is applied every two hours during labor while the fetal presentation remains within the mid-pelvic planes (DeLee − 1, 0, and + 1). The protocol includes the execution of the Three Balances SM — The Jiggle SM , Forward-leaning Inversion SM , and Side-lying Release SM —followed by the adoption of two asymmetric positions selected according to the women’s preferences and the clinical indication of the midwife in charge. Available asymmetric position options include the lunge , firefighter position, side-lying asymmetry, runner’s pose, ischial stretching, and unilateral standing asymmetry. All exercises are performed by midwives who have been previously trained with careful attention to the women’s clinical condition, comfort, and safety. These practices are repeated every two hours until fetal progression descending to the lower pelvic plane (DeLee + 2/+3). All procedures and assessments are recorded in a specific data collection form and in the WHO Labor Care Guide partograph. Control Group Participants allocated to the control group receive the institution’s standard care, which includes access to a birthing ball to facilitate free pelvic mobility, as well as the option of showering and/or immersion baths. Women maintain full freedom to adopt instinctive positions throughout labor, with no restrictions on movement. The obstetric nurse responsible for care may provide continuous support, relaxation techniques, and other interventions deemed necessary, with the exception of those included in the Spinning Babies® protocol. Labor care is provided entirely by the team of obstetric nurses in collaboration with the medical staff, following institutional policies and current clinical protocols. As this is a pragmatic trial, natural variations in care are expected, guided by both the woman’s needs and clinical assessment by healthcare professionals, in accordance with usual practice. Thus, routine interventions—such as bathing, use of the birthing ball, and ambulation—continue to be offered regardless of group allocation. For both groups, clinical decisions, including administration of oxytocin, performance of amniotomy, or indication for cesarean delivery, remain under the responsibility of the clinical care team, following the institution’s established criteria. Eligible participants are identified during labor admission and assessed for eligibility by the research team. After confirmation of eligibility, written informed consent is obtained, followed by randomization. Participants allocated to the intervention group receive the Spinning Babies® protocol every two hours while the fetal presentation remains within the mid-pelvic planes. Clinical assessments, including evaluation of fetal station, cervical dilation, fetal position, and labor progression, are performed every four hours, in accordance with institutional protocols and World Health Organization recommendations for a positive childbirth experience. Participants in both groups are followed continuously until the completion of labor and birth. A detailed schedule of enrolment, interventions, and assessments is presented in Table 1 , following the SPIRIT recommendations. Table 1 Schedule of enrolment, interventions and assessments (SPIRIT) Study period Enrolment Allocation Intrapartum follow-up Birth Postpartum (before discharge) Time point Admission to maternity unit After informed consent Every 4 hours during labor At delivery Up to 24 hours Eligibility screening X Informed consent X Randomization X Baseline assessment (sociodemographic and clinical characteristics) X Allocation to study group X Spinning Babies® intervention (intervention group only) X (every 2 hours while fetal station is − 1/0/+1) Standard intrapartum care (control group) X (continuous) Assessment of fetal station (DeLee) X Assessment of fetal position X Cervical dilation assessment X Assessment of labor progression X Recording of obstetric interventions (oxytocin, amniotomy, analgesia) X X Recording of mode of birth X Recording of maternal outcomes X X Recording of neonatal outcomes (Apgar, resuscitation, NICU) X X Adverse events monitoring X X X Data collection Data are being collected by previously trained obstetric nurses using specific data collection forms and the WHO Labor Care Guide . All data is subsequently anonymized by an external researcher, who is responsible for entering the information into the database developed in Microsoft Excel®. Access to the database is restricted to the statistical team and the principal investigators. Study outcomes The primary outcome of this randomized clinical trial is the total duration of labor, measured in minutes. Total duration of labor is defined as the time interval between the diagnosis of active labor—established by the research team according to institutional criteria (cervical dilation greater than 5 cm in the presence of three to four uterine contractions every 10 minutes)—and birth. The choice of total labor duration as the primary outcome reflects a pragmatic perspective of intrapartum care, capturing the overall clinical trajectory from active labor to birth and encompassing potential effects of the intervention across different stages of labor. This outcome will be assessed continuously until delivery. Secondary outcomes include the following: (1) progression to the next pelvic level at the first vaginal examination after randomization, defined as the proportion of parturients whose DeLee station at the subsequent assessment is recorded as below + 1; (2) progression of cervical dilation, expressed as the rate of dilation (cm/hour) between randomization and birth; (3) frequency of fetal malposition in the mid-pelvis after randomization, defined as the occurrence of any of the following conditions: asynclitism, occiput posterior position, first-, second-, or third-degree deflexion, or persistence of the same transverse or posterior position in two consecutive assessments; (4) use of interventions for labor augmentation, defined as amniotomy and/or oxytocin administration; (5) transfer to shared care with an obstetrician during labor; (6) use of intrapartum pharmacological analgesia, defined as the use of epidural analgesia, spinal analgesia, combined spinal–epidural block, or systemic analgesia (e.g., opioids); (7) rate of spontaneous, intervention-free birth, defined as vaginal birth occurring without the use of oxytocin, amniotomy, pharmacological analgesia, vacuum extraction, or forceps; (8) CS rate; (9) rate of assisted vaginal birth (vacuum extraction or forceps); and (10) composite neonatal outcome, defined as the occurrence of at least one of the following events: 5-minute Apgar score < 7, need for neonatal resuscitation in the delivery room, or transfer to the neonatal intensive care unit after birth. Safety outcomes and adverse events monitoring No specific safety outcomes were defined a priori, as the intervention consists of low-complexity, non-invasive maternal positioning and movement techniques integrated into routine intrapartum care. Nevertheless, all maternal and neonatal adverse events occurring during labor and birth will be prospectively recorded and reported, in accordance with institutional protocols and ethical requirements. All adverse events will be recorded. The intervention is expected to result in few or no adverse events potentially related to its application, and those that do occur are anticipated to be of low severity and consistent with usual obstetric practice (e.g., transient discomfort during the exercises). Serious adverse events directly associated with Spinning Babies® movements are considered unlikely, as the technique consists of low-complexity, non-invasive exercises. Non-serious adverse events, such as mild low back pain or muscular fatigue, will also be documented. Characteristics of patients at baseline The following variables were collected at the time of admission: maternal age (in completed years); educational level (elementary, secondary, or higher education; completed or not); prenatal risk classification (low risk or intermediate risk); gestational age (in weeks and days); presence of concomitant maternal conditions (hypothyroidism, hyperthyroidism, diet-controlled gestational diabetes, generalized anxiety disorder, history of treated syphilis or toxoplasmosis, and obesity); physical activity in the third trimester (< 150 or ≥ 150 minutes/week); and body composition (body mass index, kg/m²). Other Variables In addition to predefined outcomes, the following clinical and obstetric variables will be collected for descriptive and exploratory purposes. · DeLee station (fetal station in relation to the ischial spines); · Fetal position (Leopold maneuvers); · Cervical dilation (cm); · Cervical characteristics (position, consistency, edema); · Presence of a birth companion (yes/no); · Performance of Spinning Babies® exercises (yes, no, partial; number of repetitions); · Obstetric complications (non-reassuring fetal status, placental abruption, shoulder dystocia, cord prolapse, uterine rupture, maternal hypertension, tachysystole); · Reason for transfer to mixed care (obstetric nurse and physician): pharmacological analgesia, CS, arrest of labor progression, fetal heart rate abnormalities, thick meconium, fetal malposition, and abnormalities of uterine contractility; · Use of oxytocin (maximum dose in mL/h); · Amniotomy and spontaneous rupture of membranes (time and characteristics of the amniotic fluid); · Pharmacological analgesia (yes/no); · Indication for CS (as documented in the WHO Labor Care Guide); · Use of vacuum extractor or forceps (yes/no); · Mode of birth (vaginal or CS); · Perineal outcome (presence of perineal tear or episiotomy and extent of tear, if applicable); · Birth weight (grams); · Apgar score at 5 minutes; · Neonatal transfer to the NICU (yes/no); · Postpartum hemorrhage (yes/no). Statistical analysis All analyses will be conducted according to the intention-to-treat principle. Descriptive statistics will be used to summarize baseline characteristics and outcomes. Continuous variables will be described using means and standard deviations or medians and interquartile ranges, as appropriate, and categorical variables will be summarized as frequencies and percentages. Between-group comparisons for continuous outcomes will be performed using the Mann–Whitney U test or Student’s t test, depending on data distribution. Categorical outcomes will be compared using the chi-square test or Fisher’s exact test, as appropriate. An exploratory subgroup analysis is planned according to the fetal station at the first vaginal examination after randomization (DeLee − 1, 0, or + 1), to explore potential differences in intervention effects across mid-pelvic levels. No formal adjustment for baseline covariates is planned. Missing data and loss to follow-up Given the intrapartum nature of the intervention and the continuous clinical follow-up until birth, loss to follow-up is expected to be minimal. All randomized participants will be included in the primary analysis according to the intention-to-treat principle. Any missing data or protocol deviations will be documented, and their frequency and reasons will be reported in the final study report. Data monitoring and auditing Given the low-risk nature of the intervention and its integration into routine intrapartum care, a formal Data Safety Monitoring Board was not established. Study conduct and participant safety are monitored by the research team through regular supervision of protocol adherence and continuous documentation of adverse events. No external auditing procedures are planned for this trial. DISCUSSION This randomized controlled trial is designed to address an important gap in the literature regarding non-invasive strategies to support labor progression and potentially reduce unnecessary obstetric interventions. Although maternal positioning and movement during labor are widely recommended and incorporated into clinical practice, high-quality randomized evidence evaluating structured approaches tailored to fetal station and pelvic dynamics remains limited. To our knowledge, this will be the first randomized controlled trial to specifically assess the effectiveness of the Spinning Babies® approach in women with fetuses positioned in the mid-pelvis during spontaneous labor. Labor dystocia and arrest of labor progression remain among the leading indications for intrapartum CS worldwide. However, these diagnoses are often multifactorial and may reflect not only intrinsic labor physiology but also limitations in assessment, timing, and management of fetal descent and rotation. Interventions that promote maternal mobility, optimize pelvic dimensions, and facilitate physiological fetal rotation represent a promising avenue for supporting vaginal birth while preserving maternal and fetal safety. The Spinning Babies® approach proposes a structured framework that integrates intentional maternal movement with biomechanical and neurophysiological principles, aiming to address these mechanisms in a systematic manner. The pragmatic design of this trial reflects real-world intrapartum care conditions within a public maternity setting. By embedding the intervention within routine midwifery-led care and allowing standard clinical decision-making to proceed according to institutional protocols, the study seeks to maximize external validity and applicability of the findings. The choice of total duration of labor as the primary outcome captures the overall clinical trajectory from the diagnosis of active labor to birth and allows for the assessment of potential effects of the intervention across different stages of labor, rather than focusing on isolated phases alone. Several secondary outcomes were selected to provide a comprehensive evaluation of labor progression, obstetric interventions, and maternal and neonatal outcomes. These include objective measures of fetal descent and cervical dilation, use of labor augmentation and analgesia, mode of birth, and a composite neonatal outcome. Together, these outcomes will allow exploration of whether any observed effects on labor duration are accompanied by clinically meaningful changes in intervention rates and perinatal outcomes, while maintaining a clear distinction between predefined outcomes and exploratory variables. Some limitations of the study design should be acknowledged. The open-label nature of the trial precludes blinding of participants and care providers, which is inherent to complex intrapartum interventions involving maternal movement and positioning. However, objective outcome definitions, standardized data collection using the WHO Labor Care Guide, and intention-to-treat analysis are employed to mitigate potential bias. Additionally, as a single-site study conducted in a tertiary public maternity hospital, contextual factors related to local clinical protocols and staffing models may influence generalizability. Nonetheless, the shared-care, midwifery-led model adopted in this setting is increasingly promoted internationally and may enhance the relevance of the findings to similar contexts. If effective, the Spinning Babies® approach may offer a low-cost, low-risk strategy to support physiological labor progression and reduce reliance on pharmacological or surgical interventions. This has potential implications not only for individual clinical outcomes but also for broader public health efforts aimed at optimizing CS rates and promoting respectful, evidence-based intrapartum care. Conversely, if no significant differences are observed, the results will provide important evidence to inform clinical decision-making and guide future research on maternal positioning strategies during labor. In summary, this trial will contribute robust randomized evidence to an area currently dominated by observational studies and anecdotal reports. By rigorously evaluating a structured, non-invasive intrapartum intervention within routine clinical practice, the study aims to advance the evidence base supporting labor care strategies that align with physiological principles, women’s autonomy, and the judicious use of obstetric interventions. Abbreviations CS cesarean sections WHO World Health Organization RCT randomized clinical trials SUS Sistema único de Saúde BMI body mass index Cm centimeters Declarations Ethics approval and consent to participate The project was submitted to Plataforma Brasil and received approval from the Research Ethics Committee of the Universidade Federal de Santa Catarina (UFSC) under protocol number 87074625.5.3001.0096, and from the Ethics Committee of the Clinical Hospital of the Universidade Federal do Paraná (HC-UFPR) under protocol number 7.643.147. In addition, the study was registered with the Brazilian Clinical Trials Registry (REBEC) under the identifier RBR-42pbbqq. Consent for publication Written informed consent was obtained from the participant for the publication of the images included in this article. Competing Interests Maíra Libertad Soligo Takemoto is a Spinning Babies®️ Approved Trainer and provides independent professional training related to the Spinning Babies®️ approach. She is not employed by, nor does she hold any ownership or decision-making role within, the Spinning Babies®️ organization. The other authors declare that they have no competing interests. Dissemination Policy We will report the study results in accordance with the CONSORT guidelines. The findings will be published in an open-access journal. We will also submit abstracts for presentation at relevant scientific conferences. Funding The project is funded by the Brazilian National Council for Scientific and Technological Development (CNPq) and is supported by the Foundation for Research and Innovation of the State of Santa Catarina (FAPESC) through the provision of a doctoral scholarship. Author Contribution SS conceived the study, developed the research protocol under the supervision of MT and RC, coordinated the study design, and was the main contributor to the manuscript writing. MT contributed to the methodological design, supervised the development of the protocol, and critically revised the manuscript. RC contributed to the study design, supervised the development of the protocol, and critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript. Acknowledgement The authors would like to express their sincere gratitude to the nurse midwives of the Hospital de Clínicas, Universidade Federal do Paraná, for their active and committed participation in the data collection process. Their clinical expertise, professionalism, and dedication to evidence-based maternity care were essential to the implementation of this study. We also acknowledge their engagement in training activities and their continuous collaboration throughout the research development. Their contribution was fundamental to ensuring the fidelity of the intervention and the quality of the data obtained. Data Availability The datasets generated and/or analysed during the current study are not publicly available due to the sensitive nature of the clinical data and the potential risk of participant identification, particularly given the single-site study design, but are available from the corresponding author on reasonable request and subject to approval by the relevant ethics committee. References Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021;6(6):e005671. 10.1136/bmjgh-2021-005671 . PMID: 34130991; PMCID: PMC8208001. Dias BAS, Leal MDC, Esteves-Pereira AP, Nakamura-Pereira M. Variations in cesarean and repeated cesarean section rates in Brazil according to gestational age at birth and type of hospital. Cad Saude Publica. 2022;38(6):e00073621. English, Portuguese. 10.1590/0102-311XPT073621 . PMID: 35857919. 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Monthly update: How to shorten labor, integrating Spinning Babies®, and more! Spinning Babies. 6 de janeiro de 2021. Disponível em: spinningbabies.com. Tully G. Spinning Babies: guia de consulta rápida para profissionais. Carvalho L, tradutora. 1 ed. São Paulo: Editora Lexema; 2016. Gamberini C, Baronci E, De Felice C, Gagliardi C, Rispoli A, Nante N, et al. Spinning Babies® approach: A way to promote fetal head rotation during labor? Eur J Midwifery. 2024;8(September):1–8. 10.18332/ejm/191511 . Sears D. The Impact of the Spinning Babies Method on Labor Duration and Delivery Outcome [dissertation]. Minneapolis: Walden University; 2023 [cited 2026 Feb 10]. Available from: https://scholarworks.waldenu.edu/dissertations/13765 Funk B. The effects of spinning babies® on nulliparous, term, singleton, vertex (NTSV) cesarean rates: A clinical trial. Int J Obstet Gynaecol Nurs. 2024;6(2):101–6. 10.33545/26630427.2024.v7.i1b.184 . Lee S-Y. Development and effect of spinning baby-based exercise program for healthy natural childbirth: focusing on women using. J Korean Soc Wellness. 2022. http://dx.doi.org/10.21097/ksw.2022.11.17.4.301 . World Health Organization. WHO labour care guide: user's manual. Geneva: World Health Organization. 2020. 39 p. Available from: https://www.who.int/publications/i/item/9789240017566 Grenvik JM, Rosenthal E, Saccone G, Della Corte L, Quist-Nelson J, Gerkin RD, Gimovsky AC, Kwan M, Mercier R, Berghella V. Peanut ball for decreasing length of labor: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019;242:159–65. Epub 2019 Sep 20. PMID: 31600716. Additional Declarations Competing interest reported. Maíra Libertad Soligo Takemoto is a Spinning Babies®️ Approved Trainer and provides independent professional training related to the Spinning Babies®️ approach. She is not employed by, nor does she hold any ownership or decision-making role within, the Spinning Babies®️ organization. The other authors declare that they have no competing interests. Cite Share Download PDF Status: Under Review Version 1 posted Editor assigned by journal 06 Mar, 2026 Submission checks completed at journal 06 Mar, 2026 First submitted to journal 24 Feb, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8960766","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":599513450,"identity":"1c4da81d-aa84-4235-8f4d-c21517dcfc75","order_by":0,"name":"Soliane Scapin","email":"","orcid":"","institution":"Universidade Federal de Santa Catarina","correspondingAuthor":false,"prefix":"","firstName":"Soliane","middleName":"","lastName":"Scapin","suffix":""},{"id":599513451,"identity":"3f54715d-e8ef-4fd8-a063-a387361f3b19","order_by":1,"name":"Maíra Takemoto","email":"","orcid":"","institution":"Universidade Federal de Santa Catarina","correspondingAuthor":false,"prefix":"","firstName":"Maíra","middleName":"","lastName":"Takemoto","suffix":""},{"id":599513452,"identity":"b9110d03-9721-4012-90da-684846473f3a","order_by":2,"name":"Roberta Costa","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4UlEQVRIiWNgGAWjYFACHmROBQM/kGQjQksCmMXYwHCGQbKBNC2MbURoMW/vPfi48ocdA397+/MHP+cdlpBvP8D2uAKPFpkz55INzyQkM0icOWPY2LvtsITBmQR2wzN4tEhI5JhJNiQwMxhI5DA28G47XGcgwcAGch0+LeY/GxLqgVrSHzb+nQN02AzCWswYGxIOA7UkGDbzNhyWYLhBSAvPuWTJhrTjPCC/zJY5lg70S2K7IV4t7L0HPzbYVMsBQ+zBxzc11sAQO3zsIT4tMICcBhiJ0TAKRsEoGAWjAB8AAAfNSDBxk3hAAAAAAElFTkSuQmCC","orcid":"","institution":"Universidade Federal de Santa Catarina","correspondingAuthor":true,"prefix":"","firstName":"Roberta","middleName":"","lastName":"Costa","suffix":""}],"badges":[],"createdAt":"2026-02-24 19:56:00","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8960766/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8960766/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":104346129,"identity":"9b43666e-4f09-42c5-bf25-2cbbeb11f8c2","added_by":"auto","created_at":"2026-03-10 17:42:43","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1096457,"visible":true,"origin":"","legend":"\u003cp\u003eThree Balances℠ and asymmetric positioning Options by Spinning Babies®\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eA-\u003c/strong\u003e The JiggleSM; \u003cstrong\u003eB-\u003c/strong\u003e Forward-leaning InversionSM; \u003cstrong\u003eC-\u003c/strong\u003eSide-lying ReleaseSM; \u003cstrong\u003eD- \u003c/strong\u003eStanding asymmetry; \u003cstrong\u003eE-\u003c/strong\u003e Side-lying asymmetry\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-8960766/v1/e5df02f3e0dd0408a005fa10.png"},{"id":104346130,"identity":"71790be3-2033-4021-b767-211858b2bd6d","added_by":"auto","created_at":"2026-03-10 17:42:48","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2115742,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8960766/v1/cb1a96b9-10c1-4e57-8abc-50189e3eb170.pdf"}],"financialInterests":"Competing interest reported. Maíra Libertad Soligo Takemoto is a Spinning Babies®️ Approved Trainer and provides independent professional training related to the Spinning Babies®️ approach. She is not employed by, nor does she hold any ownership or decision-making role within, the Spinning Babies®️ organization. The other authors declare that they have no competing interests.","formattedTitle":"\u003cp\u003eEffect of Spinning Babies® on Labor Progression and Cesarean Delivery Rates: Protocol for an Open-Label, Two-Arm, Parallel Randomized Controlled Trial\u003c/p\u003e","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eThe global rate of cesarean sections (CS) has risen substantially, reaching 21.1% of all live births.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e Brazil has the second-highest CS rate in the world, with 57% of births occurring by CS in 2021.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e Preliminary findings from the \u003cem\u003eNascer no Brasil II\u003c/em\u003e study indicate that this percentage is now approaching 60%.\u003csup\u003e3\u003c/sup\u003e This scenario is associated with unfavorable maternal and neonatal outcomes, including higher risks of prematurity, postpartum hemorrhage, and infection.\u003csup\u003e\u003cspan additionalcitationids=\"CR5 CR6\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e For these reasons, the World Health Organization (WHO) recommends that CS rates remain within 10% to 15% and that surgical births should only be performed when clear clinical indications are present.\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAmong the main indications for CS, labor dystocia or arrest of labor progression is particularly notable.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e However, the frequency of this diagnosis may reflect limitations in the assessment and management of challenges related to fetal descent, rotation, and position within the maternal pelvis. Given these challenges and the need to reduce unnecessary obstetric interventions, national and international initiatives have sought to promote vaginal birth. Maternal positioning and movement during labor are recognized as an effective strategy to support this outcome. Evidence suggests that movements\u0026mdash;whether spontaneous or guided (intentional) \u0026mdash;improve maternal and fetal circulation, facilitate fetal positioning, and increase the likelihood of vaginal birth.\u003csup\u003e\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eWithin this context, the Spinning Babies\u0026reg; approach has emerged as a globally recognized non-invasive approach that aims to support labor progression through intentional movement combined with techniques to add balance and suppleness in the soft tissues that may affect fetal rotation and descent.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e Developed by midwife Gail Tully, this innovative approach integrates principles of neurophysiology and biomechanics to promote balance, increase space and reduce tensions within the pelvis and surrounding structures such as muscles, ligaments, and fascia.\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e Spinning Babies\u0026reg; primary goal is to assist the fetus in completing physiological rotations and descending through the pelvis, using targeted postures and exercises that match the fetal station and position.\u003csup\u003e\u003cspan additionalcitationids=\"CR12 CR13\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eDespite its widespread disseminated positive anecdotal reports and the growing body of observational data indicating its potential benefits, the Spinning Babies\u0026reg; approach still lacks randomized clinical trials (RCT) to establish their efficacy within more controlled methodological settings. To date, available evidence remains limited. One nonexperimental quantitative study found that 84% of women using Spinning Babies\u0026reg; had vaginal birth, compared with 77% of women in the standard care group, which suggests potential benefits in reducing CS.\u003csup\u003e14\u003c/sup\u003e Other studies also observed similar results, often performing before-and-after analysis.\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eTo address this gap of comparative studies, we will conduct an open-label, single-site, parallel, two-arm RCT to assess the effectiveness of Spinning Babies\u0026reg; compared with standard care to assist labor progression among women with spontaneous labor of a singleton cephalic fetus in the midpelvis (DeLee stations\u0026thinsp;\u0026minus;\u0026thinsp;1, 0 or +\u0026thinsp;1). Our hypothesis is that the approach will contribute to decrease labor length as well as obstetric intervention rates.\u003c/p\u003e"},{"header":"METHOD","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eThe aim, design, and setting of the study\u003c/h2\u003e \u003cp\u003eThe aim of this study is to evaluate the effectiveness of the Spinning Babies\u0026reg; approach on labor progression and obstetric outcomes compared with standard intrapartum care. This is a Brazilian open-label, single-center, parallel, two-arm randomized controlled trial conducted in the maternity unit of a large public university hospital in Southern Brazil.\u003c/p\u003e \u003cp\u003eThe maternity unit is fully funded by the Brazilian Public Healthcare System (Sistema \u0026Uacute;nico de Sa\u0026uacute;de \u0026ndash; SUS) and serves as a referral center for both low- and high-risk pregnancies. In 2023, the unit recorded 3,296 births, of which 2,103 (63.8%) were vaginal births and 1,193 (36.2%) were cesarean sections. Low-risk births are monitored and attended primarily by nurse midwives.\u003c/p\u003e \u003cp\u003eRecruitment and data collection began on July 2, 2025, and are expected to be completed by the end of February 2026 or upon reaching the target sample size.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eThe characteristics of participants\u003c/h3\u003e\n\u003cp\u003eThe study population includes all pregnant individuals that meet the institutional criteria to be primarily cared for by nurse midwives in accordance with the local protocol, which comprises the following criteria:\u003c/p\u003e \u003cp\u003e● Pregnant individuals classified during prenatal care as low-risk;\u003c/p\u003e \u003cp\u003e● Pregnant individuals classified as intermediate-risk with clinical stability, including the following conditions:\u003c/p\u003e \u003cp\u003e○ Hypothyroidism or hyperthyroidism with adequate clinical and laboratory control;\u003c/p\u003e \u003cp\u003e○ Gestational diabetes mellitus controlled by diet, without fetal repercussions;\u003c/p\u003e \u003cp\u003e○ Generalized anxiety disorder under good control;\u003c/p\u003e \u003cp\u003e○ History of adequately treated syphilis;\u003c/p\u003e \u003cp\u003e○ History of treated toxoplasmosis;\u003c/p\u003e \u003cp\u003e○ Isolated episode of elevated blood pressure below 160/100 mmHg, without symptoms or laboratory abnormalities, and normotensive at the time of admission;\u003c/p\u003e \u003cp\u003e○ Group B Streptococcus positive or unknown status, with prescribed antibiotic prophylaxis;\u003c/p\u003e \u003cp\u003e● Gestational age\u0026thinsp;\u0026ge;\u0026thinsp;37 weeks, with a singleton fetus in cephalic presentation;\u003c/p\u003e \u003cp\u003e● Active labor (cervical dilation\u0026thinsp;\u0026gt;\u0026thinsp;5 cm, accompanied by three to four contractions every 10 minutes);\u003c/p\u003e \u003cp\u003e● Fetal heart rate within the normal range (110\u0026ndash;160 bpm);\u003c/p\u003e \u003cp\u003e● Absence of thick meconium-stained amniotic fluid;\u003c/p\u003e \u003cp\u003e● Parturient in good overall condition: afebrile, eupneic, normotensive, and with normal pulmonary and cardiac auscultation;\u003c/p\u003e \u003cp\u003e● Body mass index (BMI)\u0026thinsp;\u0026le;\u0026thinsp;35.\u003c/p\u003e \u003cp\u003eThe study sample will consist of pregnant individuals who meet all of the inclusion and none of the exclusion criteria described below.\u003c/p\u003e \u003cp\u003e● Pregnant individuals aged 18 years or older;\u003c/p\u003e \u003cp\u003e● Term pregnancy: gestational age\u0026thinsp;\u0026ge;\u0026thinsp;37 weeks;\u003c/p\u003e \u003cp\u003e● Singleton pregnancy with a fetus in cephalic presentation;\u003c/p\u003e \u003cp\u003e● Nulliparous pregnant individuals with intact or ruptured membranes in spontaneous labor: Labor is defined as the presence of at least three regular uterine contractions within a 10-minute period and a minimum cervical dilation of 5 centimeters;\u003csup\u003e17\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e● Pregnant individuals with fetal presentation at the midpelvis. For the purposes of this study, midpelvis is defined as DeLee stations\u0026thinsp;\u0026minus;\u0026thinsp;1/0/+1, as described within the Spinning Babies\u0026reg; approach.\u003c/p\u003e \u003cp\u003eThe exclusion criteria for the study will be:\u003c/p\u003e \u003cp\u003e● Pregnant individuals with a history of practicing Spinning Babies\u0026reg; during the current pregnancy (to reduce the likelihood of co-intervention bias or unintentional cross-over);\u003c/p\u003e \u003cp\u003e● Pregnant individuals accompanied by doulas (to reduce the likelihood of co-intervention bias or unintentional cross-over);\u003c/p\u003e \u003cp\u003e● Pregnant individuals who have undergone any type of pharmacological induction;\u003c/p\u003e \u003cp\u003e● Pregnant individuals who cannot speak or understand Portuguese well;\u003c/p\u003e \u003cp\u003e● Pregnant individuals with any physical limitation or contraindication that prevents them from performing Spinning Babies\u0026reg; techniques.\u003c/p\u003e \u003cp\u003eThe sole discontinuation criterion is withdrawal from participation in the study or withdrawal of consent. Pregnant women who meet all eligibility criteria are invited to participate in the study. Eligible participants receive the informed consent form for reading and signature and are enrolled only after written informed consent has been obtained.\u003c/p\u003e\n\u003ch3\u003eDescription of processes, interventions, and comparisons\u003c/h3\u003e\n\u003cp\u003eGiven the absence of previous RCT evaluating Spinning Babies\u0026reg; to inform sample size calculation, the required sample was estimated based on the clinically relevant difference in the duration of labor (in minutes) associated with intentional positioning interventions. For this calculation, results from clinical trials investigating the use of a peanut ball were used as a reference.\u003c/p\u003e \u003cp\u003eThe mean difference of 80 minutes between two groups was adopted, based on the findings reported by Grenvik\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e for the first stage of labor as a proxy for the expected effect size. Assuming a common standard deviation of 120 minutes, a type I error risk of 5%, a type II error risk of 20%, and applying a two-tailed test with equal allocation between groups, the minimum required sample size was estimated at 37 participants per group (intervention and control).\u003c/p\u003e \u003cp\u003eParticipants are randomized in a 1:1 ratio to either the intervention group (Spinning Babies\u0026reg;) or the control group (standard care). The randomization sequence is generated in advance by an independent team of statisticians using block randomization with fixed blocks of four to ensure balance between groups throughout the recruitment period. The statistician generating the random sequence had no role in recruitment or intervention application.\u003c/p\u003e \u003cp\u003eAllocation concealment is ensured through the use of sequentially numbered, opaque, sealed envelopes containing cards indicating group assignment (intervention or control). The envelopes are prepared in advance by a researcher not involved in participant recruitment or clinical care. After eligibility is confirmed and written informed consent is obtained, the attending nurse midwife opens the next envelope in sequence to determine group allocation.\u003c/p\u003e \u003cp\u003eTo minimize the risk of contamination between groups, participants are accommodated in individual suites with no physical contact between them. Following allocation, group assignment is identified by the responsible nurse midwife using a tag displayed on the nursing station board, where all admitted patients are listed. The same identification procedure is applied to the medical staff board located in the physicians\u0026rsquo; room and on the participant\u0026rsquo;s room door, ensuring clear communication among the care teams involved while preserving allocation concealment prior to enrollment.\u003c/p\u003e \u003cp\u003ePrior to study initiation, all participating nurse midwives complete a structured 13-hour official Spinning Babies\u0026reg; training program. In addition, a 4-hour refresher training session was conducted immediately before the start of participant recruitment to reinforce intervention protocols and standardize procedures. Throughout the data collection period, the research team remains available to address questions, clarify procedures, and provide ongoing support, thereby ensuring protocol adherence, consistency in intervention delivery, and fidelity to the study design.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eIntervention Group\u003c/strong\u003e \u003cp\u003eEligible participants allocated to the intervention group receive the practices proposed by the Spinning Babies\u0026reg; protocol, which is applied every two hours during labor while the fetal presentation remains within the mid-pelvic planes (DeLee \u0026minus;\u0026thinsp;1, 0, and +\u0026thinsp;1). The protocol includes the execution of the \u003cem\u003eThree Balances\u003c/em\u003e\u003csup\u003e\u003cem\u003eSM\u003c/em\u003e\u003c/sup\u003e\u0026mdash;\u003cem\u003eThe Jiggle\u003c/em\u003e\u003csup\u003e\u003cem\u003eSM\u003c/em\u003e\u003c/sup\u003e, \u003cem\u003eForward-leaning Inversion\u003c/em\u003e\u003csup\u003e\u003cem\u003eSM\u003c/em\u003e\u003c/sup\u003e, and \u003cem\u003eSide-lying Release\u003c/em\u003e\u003csup\u003e\u003cem\u003eSM\u003c/em\u003e\u003c/sup\u003e\u0026mdash;followed by the adoption of two asymmetric positions selected according to the women\u0026rsquo;s preferences and the clinical indication of the midwife in charge. Available asymmetric position options include the \u003cem\u003elunge\u003c/em\u003e, firefighter position, side-lying asymmetry, runner\u0026rsquo;s pose, ischial stretching, and unilateral standing asymmetry.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eAll exercises are performed by midwives who have been previously trained with careful attention to the women\u0026rsquo;s clinical condition, comfort, and safety. These practices are repeated every two hours until fetal progression descending to the lower pelvic plane (DeLee\u0026thinsp;+\u0026thinsp;2/+3). All procedures and assessments are recorded in a specific data collection form and in the WHO \u003cem\u003eLabor Care Guide\u003c/em\u003e partograph.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eControl Group\u003c/strong\u003e \u003cp\u003eParticipants allocated to the control group receive the institution\u0026rsquo;s standard care, which includes access to a birthing ball to facilitate free pelvic mobility, as well as the option of showering and/or immersion baths. Women maintain full freedom to adopt instinctive positions throughout labor, with no restrictions on movement. The obstetric nurse responsible for care may provide continuous support, relaxation techniques, and other interventions deemed necessary, with the exception of those included in the Spinning Babies\u0026reg; protocol.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eLabor care is provided entirely by the team of obstetric nurses in collaboration with the medical staff, following institutional policies and current clinical protocols. As this is a pragmatic trial, natural variations in care are expected, guided by both the woman\u0026rsquo;s needs and clinical assessment by healthcare professionals, in accordance with usual practice. Thus, routine interventions\u0026mdash;such as bathing, use of the birthing ball, and ambulation\u0026mdash;continue to be offered regardless of group allocation.\u003c/p\u003e \u003cp\u003eFor both groups, clinical decisions, including administration of oxytocin, performance of amniotomy, or indication for cesarean delivery, remain under the responsibility of the clinical care team, following the institution\u0026rsquo;s established criteria.\u003c/p\u003e \u003cp\u003eEligible participants are identified during labor admission and assessed for eligibility by the research team. After confirmation of eligibility, written informed consent is obtained, followed by randomization. Participants allocated to the intervention group receive the Spinning Babies\u0026reg; protocol every two hours while the fetal presentation remains within the mid-pelvic planes. Clinical assessments, including evaluation of fetal station, cervical dilation, fetal position, and labor progression, are performed every four hours, in accordance with institutional protocols and World Health Organization recommendations for a positive childbirth experience. Participants in both groups are followed continuously until the completion of labor and birth.\u003c/p\u003e \u003cp\u003eA detailed schedule of enrolment, interventions, and assessments is presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, following the SPIRIT recommendations.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSchedule of enrolment, interventions and assessments (SPIRIT)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudy period\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEnrolment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAllocation\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIntrapartum follow-up\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBirth\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePostpartum (before discharge)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTime point\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAdmission to maternity unit\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAfter informed consent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEvery 4 hours during labor\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eAt delivery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eUp to 24 hours\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEligibility screening\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eInformed consent\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRandomization\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBaseline assessment\u003c/b\u003e (sociodemographic and clinical characteristics)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAllocation to study group\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSpinning Babies\u0026reg; intervention\u003c/b\u003e (intervention group only)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX (every 2 hours while fetal station is \u0026minus;\u0026thinsp;1/0/+1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eStandard intrapartum care\u003c/b\u003e (control group)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX (continuous)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAssessment of fetal station (DeLee)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAssessment of fetal position\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCervical dilation assessment\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAssessment of labor progression\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRecording of obstetric interventions\u003c/b\u003e (oxytocin, amniotomy, analgesia)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRecording of mode of birth\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRecording of maternal outcomes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eRecording of neonatal outcomes\u003c/b\u003e (Apgar, resuscitation, NICU)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eAdverse events monitoring\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eX\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003eData collection\u003c/h3\u003e\n\u003cp\u003eData are being collected by previously trained obstetric nurses using specific data collection forms and the \u003cem\u003eWHO Labor Care Guide\u003c/em\u003e. All data is subsequently anonymized by an external researcher, who is responsible for entering the information into the database developed in Microsoft Excel\u0026reg;. Access to the database is restricted to the statistical team and the principal investigators.\u003c/p\u003e\n\u003ch3\u003eStudy outcomes\u003c/h3\u003e\n\u003cp\u003eThe primary outcome of this randomized clinical trial is the total duration of labor, measured in minutes. Total duration of labor is defined as the time interval between the diagnosis of active labor\u0026mdash;established by the research team according to institutional criteria (cervical dilation greater than 5 cm in the presence of three to four uterine contractions every 10 minutes)\u0026mdash;and birth.\u003c/p\u003e \u003cp\u003eThe choice of total labor duration as the primary outcome reflects a pragmatic perspective of intrapartum care, capturing the overall clinical trajectory from active labor to birth and encompassing potential effects of the intervention across different stages of labor. This outcome will be assessed continuously until delivery.\u003c/p\u003e \u003cp\u003eSecondary outcomes include the following:\u003c/p\u003e \u003cp\u003e(1) progression to the next pelvic level at the first vaginal examination after randomization, defined as the proportion of parturients whose DeLee station at the subsequent assessment is recorded as below +\u0026thinsp;1;\u003c/p\u003e \u003cp\u003e(2) progression of cervical dilation, expressed as the rate of dilation (cm/hour) between randomization and birth;\u003c/p\u003e \u003cp\u003e(3) frequency of fetal malposition in the mid-pelvis after randomization, defined as the occurrence of any of the following conditions: asynclitism, occiput posterior position, first-, second-, or third-degree deflexion, or persistence of the same transverse or posterior position in two consecutive assessments;\u003c/p\u003e \u003cp\u003e(4) use of interventions for labor augmentation, defined as amniotomy and/or oxytocin administration;\u003c/p\u003e \u003cp\u003e(5) transfer to shared care with an obstetrician during labor;\u003c/p\u003e \u003cp\u003e(6) use of intrapartum pharmacological analgesia, defined as the use of epidural analgesia, spinal analgesia, combined spinal\u0026ndash;epidural block, or systemic analgesia (e.g., opioids);\u003c/p\u003e \u003cp\u003e(7) rate of spontaneous, intervention-free birth, defined as vaginal birth occurring without the use of oxytocin, amniotomy, pharmacological analgesia, vacuum extraction, or forceps;\u003c/p\u003e \u003cp\u003e(8) CS rate;\u003c/p\u003e \u003cp\u003e(9) rate of assisted vaginal birth (vacuum extraction or forceps); and\u003c/p\u003e \u003cp\u003e(10) composite neonatal outcome, defined as the occurrence of at least one of the following events: 5-minute Apgar score\u0026thinsp;\u0026lt;\u0026thinsp;7, need for neonatal resuscitation in the delivery room, or transfer to the neonatal intensive care unit after birth.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eSafety outcomes and adverse events monitoring\u003c/h2\u003e \u003cp\u003eNo specific safety outcomes were defined a priori, as the intervention consists of low-complexity, non-invasive maternal positioning and movement techniques integrated into routine intrapartum care. Nevertheless, all maternal and neonatal adverse events occurring during labor and birth will be prospectively recorded and reported, in accordance with institutional protocols and ethical requirements.\u003c/p\u003e \u003cp\u003eAll adverse events will be recorded. The intervention is expected to result in few or no adverse events potentially related to its application, and those that do occur are anticipated to be of low severity and consistent with usual obstetric practice (e.g., transient discomfort during the exercises). Serious adverse events directly associated with Spinning Babies\u0026reg; movements are considered unlikely, as the technique consists of low-complexity, non-invasive exercises. Non-serious adverse events, such as mild low back pain or muscular fatigue, will also be documented.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eCharacteristics of patients at baseline\u003c/h3\u003e\n\u003cp\u003eThe following variables were collected at the time of admission: maternal age (in completed years); educational level (elementary, secondary, or higher education; completed or not); prenatal risk classification (low risk or intermediate risk); gestational age (in weeks and days); presence of concomitant maternal conditions (hypothyroidism, hyperthyroidism, diet-controlled gestational diabetes, generalized anxiety disorder, history of treated syphilis or toxoplasmosis, and obesity); physical activity in the third trimester (\u0026lt;\u0026thinsp;150 or \u0026ge;\u0026thinsp;150 minutes/week); and body composition (body mass index, kg/m\u0026sup2;).\u003c/p\u003e\n\u003ch3\u003eOther Variables\u003c/h3\u003e\n\u003cp\u003eIn addition to predefined outcomes, the following clinical and obstetric variables will be collected for descriptive and exploratory purposes.\u003c/p\u003e \u003cp\u003e\u0026middot; DeLee station (fetal station in relation to the ischial spines);\u003c/p\u003e \u003cp\u003e\u0026middot; Fetal position (Leopold maneuvers);\u003c/p\u003e \u003cp\u003e\u0026middot; Cervical dilation (cm);\u003c/p\u003e \u003cp\u003e\u0026middot; Cervical characteristics (position, consistency, edema);\u003c/p\u003e \u003cp\u003e\u0026middot; Presence of a birth companion (yes/no);\u003c/p\u003e \u003cp\u003e\u0026middot; Performance of Spinning Babies\u0026reg; exercises (yes, no, partial; number of repetitions);\u003c/p\u003e \u003cp\u003e\u0026middot; Obstetric complications (non-reassuring fetal status, placental abruption, shoulder dystocia, cord prolapse, uterine rupture, maternal hypertension, tachysystole);\u003c/p\u003e \u003cp\u003e\u0026middot; Reason for transfer to mixed care (obstetric nurse and physician): pharmacological analgesia, CS, arrest of labor progression, fetal heart rate abnormalities, thick meconium, fetal malposition, and abnormalities of uterine contractility;\u003c/p\u003e \u003cp\u003e\u0026middot; Use of oxytocin (maximum dose in mL/h);\u003c/p\u003e \u003cp\u003e\u0026middot; Amniotomy and spontaneous rupture of membranes (time and characteristics of the amniotic fluid);\u003c/p\u003e \u003cp\u003e\u0026middot; Pharmacological analgesia (yes/no);\u003c/p\u003e \u003cp\u003e\u0026middot; Indication for CS (as documented in the WHO Labor Care Guide);\u003c/p\u003e \u003cp\u003e\u0026middot; Use of vacuum extractor or forceps (yes/no);\u003c/p\u003e \u003cp\u003e\u0026middot; Mode of birth (vaginal or CS);\u003c/p\u003e \u003cp\u003e\u0026middot; Perineal outcome (presence of perineal tear or episiotomy and extent of tear, if applicable);\u003c/p\u003e \u003cp\u003e\u0026middot; Birth weight (grams);\u003c/p\u003e \u003cp\u003e\u0026middot; Apgar score at 5 minutes;\u003c/p\u003e \u003cp\u003e\u0026middot; Neonatal transfer to the NICU (yes/no);\u003c/p\u003e \u003cp\u003e\u0026middot; Postpartum hemorrhage (yes/no).\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAll analyses will be conducted according to the intention-to-treat principle. Descriptive statistics will be used to summarize baseline characteristics and outcomes.\u003c/p\u003e \u003cp\u003eContinuous variables will be described using means and standard deviations or medians and interquartile ranges, as appropriate, and categorical variables will be summarized as frequencies and percentages.\u003c/p\u003e \u003cp\u003eBetween-group comparisons for continuous outcomes will be performed using the Mann\u0026ndash;Whitney U test or Student\u0026rsquo;s t test, depending on data distribution. Categorical outcomes will be compared using the chi-square test or Fisher\u0026rsquo;s exact test, as appropriate.\u003c/p\u003e \u003cp\u003eAn exploratory subgroup analysis is planned according to the fetal station at the first vaginal examination after randomization (DeLee\u0026thinsp;\u0026minus;\u0026thinsp;1, 0, or +\u0026thinsp;1), to explore potential differences in intervention effects across mid-pelvic levels. No formal adjustment for baseline covariates is planned.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eMissing data and loss to follow-up\u003c/h2\u003e \u003cp\u003eGiven the intrapartum nature of the intervention and the continuous clinical follow-up until birth, loss to follow-up is expected to be minimal. All randomized participants will be included in the primary analysis according to the intention-to-treat principle. Any missing data or protocol deviations will be documented, and their frequency and reasons will be reported in the final study report.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eData monitoring and auditing\u003c/h2\u003e \u003cp\u003eGiven the low-risk nature of the intervention and its integration into routine intrapartum care, a formal Data Safety Monitoring Board was not established. Study conduct and participant safety are monitored by the research team through regular supervision of protocol adherence and continuous documentation of adverse events. No external auditing procedures are planned for this trial.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis randomized controlled trial is designed to address an important gap in the literature regarding non-invasive strategies to support labor progression and potentially reduce unnecessary obstetric interventions. Although maternal positioning and movement during labor are widely recommended and incorporated into clinical practice, high-quality randomized evidence evaluating structured approaches tailored to fetal station and pelvic dynamics remains limited. To our knowledge, this will be the first randomized controlled trial to specifically assess the effectiveness of the Spinning Babies\u0026reg; approach in women with fetuses positioned in the mid-pelvis during spontaneous labor.\u003c/p\u003e \u003cp\u003eLabor dystocia and arrest of labor progression remain among the leading indications for intrapartum CS worldwide. However, these diagnoses are often multifactorial and may reflect not only intrinsic labor physiology but also limitations in assessment, timing, and management of fetal descent and rotation. Interventions that promote maternal mobility, optimize pelvic dimensions, and facilitate physiological fetal rotation represent a promising avenue for supporting vaginal birth while preserving maternal and fetal safety. The Spinning Babies\u0026reg; approach proposes a structured framework that integrates intentional maternal movement with biomechanical and neurophysiological principles, aiming to address these mechanisms in a systematic manner.\u003c/p\u003e \u003cp\u003eThe pragmatic design of this trial reflects real-world intrapartum care conditions within a public maternity setting. By embedding the intervention within routine midwifery-led care and allowing standard clinical decision-making to proceed according to institutional protocols, the study seeks to maximize external validity and applicability of the findings. The choice of total duration of labor as the primary outcome captures the overall clinical trajectory from the diagnosis of active labor to birth and allows for the assessment of potential effects of the intervention across different stages of labor, rather than focusing on isolated phases alone.\u003c/p\u003e \u003cp\u003eSeveral secondary outcomes were selected to provide a comprehensive evaluation of labor progression, obstetric interventions, and maternal and neonatal outcomes. These include objective measures of fetal descent and cervical dilation, use of labor augmentation and analgesia, mode of birth, and a composite neonatal outcome. Together, these outcomes will allow exploration of whether any observed effects on labor duration are accompanied by clinically meaningful changes in intervention rates and perinatal outcomes, while maintaining a clear distinction between predefined outcomes and exploratory variables.\u003c/p\u003e \u003cp\u003eSome limitations of the study design should be acknowledged. The open-label nature of the trial precludes blinding of participants and care providers, which is inherent to complex intrapartum interventions involving maternal movement and positioning. However, objective outcome definitions, standardized data collection using the WHO Labor Care Guide, and intention-to-treat analysis are employed to mitigate potential bias. Additionally, as a single-site study conducted in a tertiary public maternity hospital, contextual factors related to local clinical protocols and staffing models may influence generalizability. Nonetheless, the shared-care, midwifery-led model adopted in this setting is increasingly promoted internationally and may enhance the relevance of the findings to similar contexts.\u003c/p\u003e \u003cp\u003eIf effective, the Spinning Babies\u0026reg; approach may offer a low-cost, low-risk strategy to support physiological labor progression and reduce reliance on pharmacological or surgical interventions. This has potential implications not only for individual clinical outcomes but also for broader public health efforts aimed at optimizing CS rates and promoting respectful, evidence-based intrapartum care. Conversely, if no significant differences are observed, the results will provide important evidence to inform clinical decision-making and guide future research on maternal positioning strategies during labor.\u003c/p\u003e \u003cp\u003eIn summary, this trial will contribute robust randomized evidence to an area currently dominated by observational studies and anecdotal reports. By rigorously evaluating a structured, non-invasive intrapartum intervention within routine clinical practice, the study aims to advance the evidence base supporting labor care strategies that align with physiological principles, women\u0026rsquo;s autonomy, and the judicious use of obstetric interventions.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ecesarean sections\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eWHO\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eWorld Health Organization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003erandomized clinical trials\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSUS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSistema \u0026uacute;nico de Sa\u0026uacute;de\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBMI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ebody mass index\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCm\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ecentimeters\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":" \u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e \u003cp\u003e The project was submitted to Plataforma Brasil and received approval from the Research Ethics Committee of the Universidade Federal de Santa Catarina (UFSC) under protocol number 87074625.5.3001.0096, and from the Ethics Committee of the Clinical Hospital of the Universidade Federal do Paran\u0026aacute; (HC-UFPR) under protocol number 7.643.147. In addition, the study was registered with the Brazilian Clinical Trials Registry (REBEC) under the identifier RBR-42pbbqq.\u003c/p\u003e \u003ch2\u003eConsent for publication\u003c/h2\u003e \u003cp\u003e Written informed consent was obtained from the participant for the publication of the images included in this article.\u003c/p\u003e\u003ch2\u003eCompeting Interests\u003c/h2\u003e\u003cp\u003eMa\u0026iacute;ra Libertad Soligo Takemoto is a Spinning Babies\u0026reg;️ Approved Trainer and provides independent professional training related to the Spinning Babies\u0026reg;️ approach. She is not employed by, nor does she hold any ownership or decision-making role within, the Spinning Babies\u0026reg;️ organization. The other authors declare that they have no competing interests.\u003c/p\u003e\u003ch2\u003eDissemination Policy\u003c/h2\u003e \u003cp\u003e We will report the study results in accordance with the CONSORT guidelines. The findings will be published in an open-access journal. We will also submit abstracts for presentation at relevant scientific conferences.\u003c/p\u003e \u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThe project is funded by the Brazilian National Council for Scientific and Technological Development (CNPq) and is supported by the Foundation for Research and Innovation of the State of Santa Catarina (FAPESC) through the provision of a doctoral scholarship.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eSS conceived the study, developed the research protocol under the supervision of MT and RC, coordinated the study design, and was the main contributor to the manuscript writing. MT contributed to the methodological design, supervised the development of the protocol, and critically revised the manuscript. RC contributed to the study design, supervised the development of the protocol, and critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eThe authors would like to express their sincere gratitude to the nurse midwives of the Hospital de Cl\u0026iacute;nicas, Universidade Federal do Paran\u0026aacute;, for their active and committed participation in the data collection process. Their clinical expertise, professionalism, and dedication to evidence-based maternity care were essential to the implementation of this study. We also acknowledge their engagement in training activities and their continuous collaboration throughout the research development. Their contribution was fundamental to ensuring the fidelity of the intervention and the quality of the data obtained.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets generated and/or analysed during the current study are not publicly available due to the sensitive nature of the clinical data and the potential risk of participant identification, particularly given the single-site study design, but are available from the corresponding author on reasonable request and subject to approval by the relevant ethics committee.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBetran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. 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PMID: 31600716.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Pregnant People; Obstetrics, Labor obstetric, Natural childbirth, Obstetric Nursing, Patient Positioning, Labor Presentation","lastPublishedDoi":"10.21203/rs.3.rs-8960766/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8960766/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCesarean section rates remain high worldwide, especially in Brazil, where they far exceed international recommendations. Arrest of labor progression is one of the main indications for intrapartum cesarean delivery and is frequently related to challenges in fetal descent, rotation, and positioning within the maternal pelvis. Maternal movement and positioning during labor are recognized strategies to support physiological labor progression. The Spinning Babies\u0026rsquo;s\u0026reg; approach is a non-invasive method based on intentional movements and positioning, developed to facilitate fetal rotation and descent. Despite its widespread use in clinical practice, to date there are no randomized controlled trials evaluating the effectiveness of this approach, highlighting a relevant gap in scientific knowledge. This study aims to assess the effectiveness of the Spinning Babies\u0026reg; approach on labor progression and obstetric outcomes compared with standard intrapartum care.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis is an open-label, single-center, parallel, two-arm randomized controlled trial conducted in a large public university maternity hospital in Southern Brazil. Nulliparous women aged 18 years or older, at term, with singleton pregnancies, cephalic fetal presentation, and fetuses located in the midpelvis during spontaneous labor will be included. Participants will be randomized in a 1:1 ratio to receive either the Spinning Babies\u0026reg; intervention or standard care. The intervention consists of applying Spinning Babies\u0026reg; positioning and movement exercises every two hours while the fetal presentation remains in the midpelvis. The primary outcome is total labor duration, measured from the diagnosis of active labor to birth. Secondary outcomes include measures of labor progression, use of obstetric interventions, mode of birth, and neonatal outcomes. Analyses will follow the intention-to-treat principle.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThis trial was designed to address the lack of randomized evidence regarding the Spinning Babies\u0026reg; approach, contributing to knowledge improvement of non-invasive strategies to support labor progression. By evaluating this intervention within the context of routine midwifery-led care, the study may inform evidence-based intrapartum practices and also may contribute to the reduction of unnecessary obstetric interventions such as cesarean sections. \u003cb\u003eTrial registration\u003c/b\u003e: Brazilian Clinical Trials Registry (REBEC), identifier RBR-42pbbqq, prospectively registered.\u003c/p\u003e","manuscriptTitle":"Effect of Spinning Babies® on Labor Progression and Cesarean Delivery Rates: Protocol for an Open-Label, Two-Arm, Parallel Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-10 17:42:37","doi":"10.21203/rs.3.rs-8960766/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorAssigned","content":"","date":"2026-03-06T11:53:26+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-03-06T11:48:30+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pregnancy and Childbirth","date":"2026-02-24T19:35:45+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"38aa26d0-8af5-45c2-8f5d-6e10a9de7850","owner":[],"postedDate":"March 10th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-03-10T21:08:09+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-10 17:42:37","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8960766","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8960766","identity":"rs-8960766","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}