Effectiveness of Family Planning Interventions among Pregnant and Postpartum Women: Protocol for a Cluster Randomized Controlled Trial.

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Gita Shrestha, Minato Nakazawa This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6868572/v2 This work is licensed under a CC BY 4.0 License Status: Posted Version 2 posted You are reading this latest preprint version Show more versions Abstract Background Postpartum family planning PPFP aims to prevent unintended and closely spaced pregnancies within the first year after childbirth. Despite global progress, South Asia, including Nepal, struggles with lower contraceptive use and high unmet needs, which ultimately impacts infant, neonatal, and maternal mortality. Religious beliefs and poor knowledge hinder contraceptive use. Integrating family planning into antenatal and postnatal care and involving male partners are crucial for improving contraceptive uptake. This study addresses the issues at the community level using a cluster-randomized trial in Nepal, aiming to enhance the contraceptive use among postpartum women. Methods A cluster-randomized controlled trial was conducted in Sindhuli, Nepal, with a one-year follow-up period from February 2023 to April 2024. Married women of reproductive age (15–49), who were either in their third trimester of pregnancy or within six months postpartum, were assigned to either the intervention or control arm from eight healthcare facilities. In the intervention arm, a family planning trained health counselor (FPTHC) conducted six home visits over the study period, providing counseling to the participant, her husband, and her mother-in-law at various time intervals. Quantitative data were collected longitudinally through interviews across eight healthcare facilities. Descriptive analysis was performed using Jamovi, and statistical analysis was conducted using a logistic regression model. Conclusions This study protocol will provide evidence on the effectiveness of family planning interventions in increasing the uptake of modern contraceptive methods, thereby reducing unmet needs during the crucial postpartum period. The findings could support the government in developing policies and strategies related to postpartum interventions. Trial registration UMIN-CTR Individual Case Data (UMIN-ICDS), UMIN000049503[ 14 ] Obstetrics & Gynecology Women's studies Contraceptive use family planning intervention postpartum randomized controlled trial Nepal Full Text Additional Declarations The authors declare no competing interests. Supplementary Files Supplementaryfile.docx Cite Share Download PDF Status: Posted Version 2 posted You are reading this latest preprint version Show more versions 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. 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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-6868572","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Method Article","associatedPublications":[],"authors":[{"id":470815879,"identity":"d25e1be9-5a7c-4d95-9005-a333afdc86fd","order_by":0,"name":"Gita Shrestha","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6ElEQVRIiWNgGAWjYDACZjB5gIGNmfkAkCEhQ4QWkJ6EAwx87GwJIC08RFoD1CLHz2MA4hLWIu/Of0zy54878mzMPJ9f3aix4GFgP3x0Az4thoeZ2aR5Ep4ZtjHzbrPOOQZ0GE9a2g28WpqBWhgSDjOCtBjnsAG1SPCYEdQi+SPhsH0bM88z45x/RGiRZ2YGmpxwOBGohflxbhsRWgyYmY2tedIOJ7cxs5kx5/ZJ8LAR8ot8/8GHN3/YHLad33/48eecb3Vy/OyHj+G35QCCzSYBJvEpB9vSgGAzfyCkehSMglEwCkYmAABMhT7ibGxNmgAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0009-0006-6093-9986","institution":"Kobe University Graduate School of Health Sciences, Kobe, Japan","correspondingAuthor":true,"prefix":"","firstName":"Gita","middleName":"","lastName":"Shrestha","suffix":""},{"id":470815880,"identity":"ad2b77b3-f626-4712-8a18-717da1e4827b","order_by":1,"name":"Minato Nakazawa","email":"","orcid":"https://orcid.org/0000-0003-2345-8455","institution":"Kobe University Graduate School of Health Sciences, Kobe, Japan","correspondingAuthor":false,"prefix":"","firstName":"Minato","middleName":"","lastName":"Nakazawa","suffix":""}],"badges":[],"createdAt":"2025-06-11 06:43:14","currentVersionCode":2,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":true,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-6868572/v2","doiUrl":"https://doi.org/10.21203/rs.3.rs-6868572/v2","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":85335047,"identity":"e443155e-e20d-49d8-8007-2b9fb60f70b1","added_by":"auto","created_at":"2025-06-24 19:46:49","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":559292,"visible":true,"origin":"","legend":"","description":"","filename":"ManuscriptProtocol2025.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6868572/v2_covered_46409879-f634-4f7b-85b8-e1b4250f1d0d.pdf"},{"id":85333949,"identity":"ce7081b5-7ce5-4dc8-9dc2-6b41e4586e46","added_by":"auto","created_at":"2025-06-24 19:22:48","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":2413074,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfile.docx","url":"https://assets-eu.researchsquare.com/files/rs-6868572/v2/cf814400e3f66a4fec8b7ced.docx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"Effectiveness of Family Planning Interventions among Pregnant and Postpartum Women: Protocol for a Cluster Randomized Controlled Trial.","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"NEXT Generation Outstanding Research grant for Pioneering Doctoral Students at Kobe University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Contraceptive use, family planning, intervention, postpartum, randomized controlled trial, Nepal","lastPublishedDoi":"10.21203/rs.3.rs-6868572/v2","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6868572/v2","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePostpartum family planning PPFP aims to prevent unintended and closely spaced pregnancies within the first year after childbirth. Despite global progress, South Asia, including Nepal, struggles with lower contraceptive use and high unmet needs, which ultimately impacts infant, neonatal, and maternal mortality. Religious beliefs and poor knowledge hinder contraceptive use. Integrating family planning into antenatal and postnatal care and involving male partners are crucial for improving contraceptive uptake. This study addresses the issues at the community level using a cluster-randomized trial in Nepal, aiming to enhance the contraceptive use among postpartum women.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA cluster-randomized controlled trial was conducted in Sindhuli, Nepal, with a one-year follow-up period from February 2023 to April 2024. Married women of reproductive age (15\u0026ndash;49), who were either in their third trimester of pregnancy or within six months postpartum, were assigned to either the intervention or control arm from eight healthcare facilities. In the intervention arm, a family planning trained health counselor (FPTHC) conducted six home visits over the study period, providing counseling to the participant, her husband, and her mother-in-law at various time intervals. Quantitative data were collected longitudinally through interviews across eight healthcare facilities. Descriptive analysis was performed using Jamovi, and statistical analysis was conducted using a logistic regression model.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThis study protocol will provide evidence on the effectiveness of family planning interventions in increasing the uptake of modern contraceptive methods, thereby reducing unmet needs during the crucial postpartum period. 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