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Enrolling by Invitation

NCT Number: NCT07438379

Exploring Reproductive Health Among Women in Somaliland

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.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

University of Hargeisa

Hargeisa, Maroodijeeh, +252, Somalia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Adverse birth outcomes

    Time frame: Assessed 1 to 3 months post partum

    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.

Secondary outcomes

  1. Antenatal care visits

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

    Proportion of women receiving four or more visits.

  2. Proportion of pregnant women with hypertensive disorders of pregnancy (HDP)

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

    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).

  3. Proportion of pregnant women with Gestational Diabetes

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

    Fasting blood glucose level >92 mg/dL (5.1 mmol/L)

  4. Postpartum depression

    Time frame: One to three months postpartum

    Using Edingburgh Postpartum Depression Scale including a 4 point likert scale with higher values indicating signs of depression.

  5. Social support

    Time frame: Assessed between gestational age 36 and birth

    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).

  6. Self-care

    Time frame: Assessed between gestational age 36 and birth

    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.

  7. Collective Decision-making

    Time frame: Assessed between gestational age 36 and birth

    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)).

  8. Wish to use contraception

    Time frame: One to three months postpartum

    Yes / no

  9. Contraceptive plans

    Time frame: One to three months postpartum

    Yes / no

  10. Contraception use

    Time frame: One to three months postpartum

    Yes / no

Sponsors and collaborators

Lead sponsor

University of Hargeisa

Other

Registry information

Official study title

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

Acronym: PROMISE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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