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Reproductive HealthPROMISENCT07438379

Exploring Reproductive Health Among Women in Somaliland

An observational study of Reproductive Health and Gestatiaonl Diabetes Mellitus, run by University of Hargeisa at 1 site in Somalia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
How many people
808 participants
Where
1 siteSomalia
Study dates
1 Jan 2025to 31 Mar 2026
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Somalia1 site

  • University of Hargeisa

    Hargeisa, Maroodijeeh, +252

About this study

Official title: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessed 1 to 3 months post partum

Secondary outcomes (10)

  1. Antenatal care visits

    Proportion of women receiving four or more visits.

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

  2. 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).

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

  3. Proportion of pregnant women with Gestational Diabetes

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

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

  4. Postpartum depression

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

    Measured: One to three months postpartum

  5. 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).

    Measured: Assessed between gestational age 36 and birth

  6. 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.

    Measured: Assessed between gestational age 36 and birth

  7. 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)).

    Measured: Assessed between gestational age 36 and birth

  8. Wish to use contraception

    Yes / no

    Measured: One to three months postpartum

  9. Contraceptive plans

    Yes / no

    Measured: One to three months postpartum

  10. Contraception use

    Yes / no

    Measured: One to three months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Jan 2025
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
808 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07438379
Sponsor's protocol ID
PROMISE_Study_Hargeisa_477/6
Acronym
PROMISE
Status last verified
Feb 2026
First submitted
15 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Reproductive Health and Gestatiaonl Diabetes Mellitus, run by University of Hargeisa at 1 site in Somalia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Somalia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse birth outcomes (time frame: Assessed 1 to 3 months post partum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07438379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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