A package of interventions to increase facility births attended by a birth companion in Ethiopia, Kenya, and Nigeria: A cluster-randomized controlled trial

Background Despite the World Health Organization’s recommendation of offering women the option to have a birth companion of their choice, implementation of this recommendation remains limited in low- and middle-income countries, including Ethiopia, Kenya, and Nigeria. This study assessed if a tailored set of programmatic interventions targeting common barriers to birth companionship could increase the proportion of women giving birth with a companion.

In this cluster-randomized trial,12 facilities in Ethiopia, 24 facilities across Machakos and Murang’a counties in Kenya, and 24 facilities in Kano and Nasarawa states in Nigeria were randomized (3:1) to intervention and control arms (ClinicalTrials.gov NCT05565196). The intervention was introduced over a period of two months and was evaluated after 12 additional months of implementation. We enrolled women having vaginal births. Data were collected at baseline, quarterly, and one year, using a facility survey and qualitative interviews with women, birth companions, health workers, and unit managers. We used a cluster-weighted chi-square test to compare intervention and control arms with respect to the primary outcome, which was the proportion of women accompanied in the facility by a companion during labor, birth, and postnatal periods. Difference-in-difference analysis was also done. Findings 1,475 women in Ethiopia, 1,496 in Machakos and 1,521 in Murang’a Counties of Kenya and 1,644 in Kano and 1,249 in Nasarawa states of Nigeria were recruited. At end-line, primary outcome increased in intervention arm by 38% points (95%CI=12-66, p=0.009) in Ethiopia,15% points (95%CI=7-26, p=0.002) in Murang’a, 9% points in Machakos (95%CI=-1-20, p=0.077), 51%(95%CI=9-93, p=0.018) points in Kano state, and 53% points in Nasarawa state (95%CI=11-96, 0.014). Interpretation A tailored interventions reduced barriers to women having continuous companionship in facilities during labor, birth, and the postnatal period and has potential for use in a range of facility types and settings aiming to increase client-centered intrapartum care. Competing Interest Statement The authors have declared no competing interest. Clinical Trial ClinicalTrials.gov, NCT05565196 Clinical Protocols https://pubmed.ncbi.nlm.nih.gov/37838662/ Funding Statement Yes Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the Addis Continental Institute of Public Health Institutional Review Board (IRB) (FWA 00015151) in Ethiopia, Amref Health Ethical Review Committee (FWA 00018713) in Kenya, the National Health Research Ethics Committee (NHREC/01/01/2007) in Nigeria, and the John Hopkins Bloomberg School of Public Health IRB (No 21183) in the United States. All methods were carried out in accordance with relevant guidelines and regulations of the study countries. Oral informed consent from participants for both quantitative and qualitative components was taken and witnessed and recorded by the data collector. Confidentiality was kept to the maximum standard during data collection and data handling. The study protocol has been published [25] and the study is registered with ClinicalTrials.gov (NCT05565196), first posted on October 4, 2022. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability The URLs/accession numbers/DOIs will be available only after acceptance of the manuscript for publication so that we can ensure their inclusion before publication.