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Enrolling By InvitationNCT07438379

Exploring Reproductive Health Among Women in Somaliland

Exploring Reproductive Health Among Women in Somaliland: Protocol for a Community-based Prospective Cohort Study and an Intervention Co-creation (The PROMISE Study)

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
808 (estimated)
Sponsor
University of Hargeisa · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

Somaliland faces persistently high burdens of maternal and perinatal mortality, with limited population-based data on pregnancy complications, sociocultural influence on maternal health, and women's reproductive health needs across the continuum of pregnancy, childbirth, and postpartum. Existing maternal near-miss (MNM) tools are largely facility-based, and evidence of postpartum contraceptive uptake and interventions remains scarce. In response, the objective of this study is to unfold the physical, cultural, and psychosocial strengths and challenges experienced by women in Somaliland during pregnancy, childbirth, and the postpartum period; to examine how these factors interact to influence pregnancy outcomes and women's ability to achieve future reproductive health goals; and to pilot how these insights can inform the co-creation of context-appropriate health materials. The PROMISE study is a community-based longitudinal pregnancy cohort in Hargeisa, Somaliland, including approximately 800 pregnant women \<28 weeks of gestation recruited from randomly selected sub-districts. Women will be followed up at three time points (early pregnancy, late pregnancy, and postpartum) using questionnaires and clinical measurements. A MNM tool will be adapted through a Delphi process, and its validity will be tested using the cohort. The cohort findings will inform a co-creation process to develop postpartum contraceptive counselling materials to be pilot-tested for feasibility, acceptability, and preliminary effects. This protocol responds to major evidence gaps in fragile and low-resource contexts, and aims to generate contextually grounded knowledge and co-created interventions to strengthen maternal health policy, practice, and reproductive agency in Somaliland and beyond.

Conditions

Timeline

Start date
2025-01-01
Primary completion
2026-03-31
Completion
2026-03-31
First posted
2026-02-27
Last updated
2026-02-27

Locations

1 site across 1 country: Somalia

Source: ClinicalTrials.gov record NCT07438379. Inclusion in this directory is not an endorsement.