Exploring Reproductive Health Among Women in Somaliland (PROMISE)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Contraception; Antenatal Care; Reproductive Health; Gestatiaonl Diabetes Mellitus; Hypertensive Disorders of Pregnancy

• Study Type: Observational
• Enrollment (Estimated): 808

Contacts and Locations

Study Locations

• Somalia
  • Maroodijeeh
    • Hargeisa, Maroodijeeh, Somalia, +252
      • University of Hargeisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antenatal care visits	Proportion of women receiving four or more 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)	Hypertension include all women with a blood pressure > 90 diastolic or >140 systolic. Pre-eclampsia is defined as women with a blood pressure > 90 diastolic or > 140 systolic cooccurring with proteinuria. 'Pre-eclampsia with severe features' is defined as pre-eclampsia with description of at least one of the following symptoms severe headache, swelling of the face, upper abdominal pain or oliguria (less that a table spoon).	Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum
Proportion of pregnant women with Gestational Diabetes	Fasting blood glucose level >92 mg/dL (5.1 mmol/L)	Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum
Postpartum depression	Using Edingburgh Postpartum Depression Scale including a 4 point likert scale with higher values indicating signs of depression.	One to three months postpartum
Social support	Assessed using the Multidimensional Scale of Perceived Social Support (MSPSS) tool, which contains 12 items rated on a 7-point Likert scale (1 = very strongly disagree, 7 = very strongly agree). Based on the mean item scores, the following categories will be used: low support (<3), moderate support (3-5) and high support (>5).	Assessed between gestational age 36 and birth
Self-care	Using the Appraisal of Self-care Agency Scale Revised (ASAS-R) score, which is a 15-item scale that appraises the enabling traits of self-care agency, and uses a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with total scores ranging from 15 to 75, with higher scores indicating greater self-care agency.	Assessed between gestational age 36 and birth
Collective Decision-making	Distinguishes between decisions made by the women and other people. Each decision-maker category (e.g., the woman herself, husband/partner, parents, in-laws, grandmother, friends) will be coded as 1 = involved and 0 = not involved and will be summed to create a variable representing the total number of people involved. The variable will initially be treated as a continuous to assess potential relationships between increasing involvement and the likelihood of severe maternal outcomes. If the distribution is skewed or non-linear, categories will be created (e.g., low involvement (1-2 people) vs. high involvement (≥3 people)).	Assessed between gestational age 36 and birth
Wish to use contraception	Yes / no	One to three months postpartum
Contraceptive plans	Yes / no	One to three months postpartum
Contraception use	Yes / no	One to three months postpartum

Collaborators and Investigators

• Sponsor: University of Hargeisa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PROMISE_Study_Hargeisa_477/6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No