Exploring Reproductive Health Among Women in Somaliland

NCT07438379 | Enrolling By Invitation DMC

• 1 other identifier: PROMISE_Study_Hargeisa_477/6
• Study Type: observational
• Target: 808
• Locations: 1 country
• Sites: 1

Brief 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

Reproductive Health; Gestatiaonl Diabetes Mellitus; Hypertensive Disorders of Pregnancy; Contraception; Antenatal Care

Outcome Measures

Primary Outcomes (1)

• Adverse birth outcomes

  A composite of admission to neonatal intensive care unit, mode of birth (vaginal birth, assisted vaginal birth, and cesarean section), postpartum hemorrhage \> 1000 ml, eclampsia, maternal death, stillbirth in 3rd trimester, neonatal death within one and seven days, preterm birth \< week 37, and low birth weight \< 2000 grams.

  Assessed 1 to 3 months post partum

Secondary Outcomes (10)

• Antenatal care visits

  Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum

• Proportion of pregnant women with hypertensive disorders of pregnancy (HDP)

  Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum

• Proportion of pregnant women with Gestational Diabetes

  Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum

• Postpartum depression

  One to three months postpartum

• Social support

  Assessed between gestational age 36 and birth

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women residing in randomly selected subdistricts of Hargeisa, Somaliland.

You may qualify if:

• Pregnant woman
• Gestational age less than 28 weeks at the time of recruitment

Sponsors & Collaborators

• University of Hargeisa: lead

Study Sites (1)

University of Hargeisa

Hargeisa, Maroodijeeh, +252, Somalia

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

SO (1)