Postpartum Family Planning Program in Rwanda

NCT05056545 | Completed DMC

• 3 other identifiers: STUDY00002354R01HD1016002023P006031
• Study Type: interventional
• Target: 42,377
• Locations: 1 country
• Sites: 1

Brief Summary

This trial wants to address high unmet need for postpartum family planning (PPFP) in Rwanda. A previous pilot study tested the intervention (informed by formative work with couples/clients, clinic providers, champions, and community health workers), which significantly increased the use of PPFP in government clinics. This study now proposes to use an implementation science framework to test the hypothesis that the proposed PPFP intervention is adaptable to large-scale implementation, cost-effective, and sustainable. This PPFP could dramatically reduce unintended pregnancy and abortion and improve birth spacing and maternal and newborn health.

Conditions

Family Planning

Keywords

Postpartum; Intrauterine Device; Long-acting reversible contraception

Outcome Measures

Primary Outcomes (8)

• Numbers of clinic directors engaged

  Numbers of clinic directors engaged to provide the PPFP Intervention

  Through study completion, an average of 3 years

• Number of Nurses trained to promote PPFP

  The number of nurses who complete PPFP intervention session to promote PPFP use

  After completion of a 2-day training

• Number of CHWs trained to promote PPFP

  The number of CHWs who complete C4 training session to promote PPFP use

  After completion of a 2-day training session

• Number of providers trained to provide PPFP

  Nurses and midwives working labor and delivery and family planning will attend a 2-day didactic training session. Providers will complete a post-training test consisting of 10 true or false questions. Those who do not score at least 80% on the post-training test will be offered re-training after one week.

  After completion of a 2-day training session

• Number of providers certified to provide PPFP

  After completing the didactic training, providers will have the opportunity to become certified, by correctly inserting 5 PPIUDs and 5 PP implants under supervision.

  After completion of a 2-day training session

• Number of promotions to pregnant or postpartum women/couples

  The number of pregnant or postpartum women/couples receiving one-on-one C4 counseling

  Beginning at the first antenatal care visit up to post-partum week 14 (up to 54 weeks)

• Number of PPIUD insertions

  The number of postpartum women who opt to have a PPIUD inserted

  Up to postpartum week 14

• Number of PP implant insertions

  The number of postpartum women who opt to have a PP implant inserted.

  Up to postpartum week 14

Secondary Outcomes (2)

• Cost-effectiveness/cost-utility: Couple Years Protection (CYP)

  Years 2 and 4 of the project period

• Cost-effectiveness/cost-utility: Cost per Quality Adjusted life years (QALY)

  Years 2 and 4 of the project period

Study Arms (2)

PPFP Intervention

EXPERIMENTAL

The study team will train government clinic staff in ANC, L\&D, IV, or postpartum services to promote and provide the PPFP intervention at the selected facilities. Community Health Workers (CHW) and 'Happy Clients' will be trained as PPFP promotional agents. Video-based PPFP promotions will be shown at the intervention facilities. If interested in PPFP, women will be referred to the facility by their CHW.

Behavioral: C4 Intervention

Standard of Care

NO INTERVENTION

Currently, no systematic PPFP training, promotional, or service delivery activities are regularly taking place at the selected facilities. The team will compare the intervention with historical records from the facilities applying intervention and compare

Interventions

C4 Intervention BEHAVIORAL

C4 Intervention, is an innovative form of Post Partum Family Planning (PPFP). PPFP methods include: the copper intrauterine device, hormonal implant, tubal ligation, and (after 6 weeks post-partum in breastfeeding women) Depo-Provera and oral contraceptive pills. These are provided as current, standard of care in Rwanda, are procured by the government, and administered by trained nurses and doctors. The C4 training will occur at the 4 pilot facilities. Training will include a 2-day didactic session covering PPFP provision, follow-up, use of the C4 counseling flipchart; mock counseling sessions; and PPIUD and PP implant insertion and removal trainings. The study team will train government clinic staff in family planning, ANC, L\&D, and IV to promote C4 at the selected facilities. 'Happy Clients' will be recruited from women who received promotions and selected PPFP to join a clinic-based PPFP promotions team. Women interested in PPFP will be referred to the facility by their CHW.

PPFP Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible PPFP promoters will be government facility providers working in ANC,L\&D, IV and/or postpartum services at one of the study facilities.
• Eligible PPFP providers will be government facility providers working in L\&D, and/or family planning services at one of the study facilities.
• Eligible Happy Client promotors will be postpartum women who received promotions and selected a PPFP method.
• Eligible nurse/midwife and CHW promotors will be women working as nurses or CHWs at one of the intervention facilities.
• All women eligible for PPFP services in this study will be at any stage of pregnancy or up to 14 weeks postpartum, and receiving antenatal care (ANC), L\&D, IV, or postpartum services at one of the intervention or pilot facilities

You may not qualify if:

• Prisoners

Sponsors & Collaborators

• Emory University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Project San Francisco, Kigali

Kigali, Kigali, Rwanda

Location

Related Publications (1)

• Wall KM, Ingabire R, Mazzei A, Umuhoza C, Parker R, Tichacek A, Nizam A, Sales JM, Haddad LB, Corso P, Allen S, Nyombayire J, Karita E. Implementation and evaluation of a large-scale postpartum family planning program in Rwanda: study protocol for a clinic-randomized controlled trial. Trials. 2022 Apr 22;23(1):337. doi: 10.1186/s13063-022-06261-5.

  PMID: 35459259 DERIVED

Study Officials

• Kristin Wall, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This step-wedge clinical trial will train all nurse/midwives working in antenatal care (ANC), labor and delivery (L\&D), infant vaccination (IV), or postpartum services at one of the study facilities in PPFP promotions or provision. The study team will train 'Happy Clients' (postpartum women who received promotions and selected a PPFP method) and community health workers affiliated with the intervention facilities as PPFP promotional agents. Women eligible for PPFP services in this study will be at any stage of pregnancy or up to 14 weeks postpartum, and receiving ANC, L\&D, IV, or postpartum services at one of the intervention facilities.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: August 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: February 19, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication, ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by the Rwanda National Ethics Committee, to achieve the aims in the approved proposal. Proposals should be directed to kmwall@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

RW (1)