Exploring Reproductive Health Among Women in Somaliland (PROMISE)

February 22, 2026 updated by: Soheir Hassan Ahmed, University of Hargeisa

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
808

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Assessed 1 to 3 months post partum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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).
Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum
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)
Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum
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.
One to three months postpartum
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).
Assessed between gestational age 36 and birth
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.
Assessed between gestational age 36 and birth
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)).
Assessed between gestational age 36 and birth
Wish to use contraception
Time Frame: One to three months postpartum
Yes / no
One to three months postpartum
Contraceptive plans
Time Frame: One to three months postpartum
Yes / no
One to three months postpartum
Contraception use
Time Frame: One to three months postpartum
Yes / no
One to three months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Hargeisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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