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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07438379
Acronym
PROMISE
Enrollment
808
Registered
2026-02-27
Start date
2025-01-01
Completion date
2026-03-31
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

University of Hargeisa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse birth outcomesAssessed 1 to 3 months post partumA 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.

Secondary

MeasureTime frameDescription
Antenatal care visitsAssessed between gestational age 36 and birth as well as between 1 to 3 months postpartumProportion of women receiving four or more visits.
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 postpartumHypertension 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).
Proportion of pregnant women with Gestational DiabetesAssessed between gestational age 36 and birth as well as between 1 to 3 months postpartumFasting blood glucose level \>92 mg/dL (5.1 mmol/L)
Postpartum depressionOne to three months postpartumUsing Edingburgh Postpartum Depression Scale including a 4 point likert scale with higher values indicating signs of depression.
Social supportAssessed between gestational age 36 and birthAssessed 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).
Self-careAssessed between gestational age 36 and birthUsing 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.
Collective Decision-makingAssessed between gestational age 36 and birthDistinguishes 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)).
Wish to use contraceptionOne to three months postpartumYes / no
Contraceptive plansOne to three months postpartumYes / no
Contraception useOne to three months postpartumYes / no

Countries

Somalia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026