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Набор по приглашению NCT07438379

Exploring Reproductive Health Among Women in Somaliland

— Наблюдательное Reproductive Health Gestatiaonl Diabetes Mellitus Hypertensive Disorders of Pregnancy Contraception

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Reproductive Health, Gestatiaonl Diabetes Mellitus, Hypertensive Disorders of Pregnancy, Contraception. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Somalia
Следующий шаг
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Официальное название

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

Обзор

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.

Первичные конечные точки

  • Adverse birth outcomes [Срок оценки: Assessed 1 to 3 months post partum]
Вторичные конечные точки (10)
  • Antenatal care visits [Срок оценки: 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) [Срок оценки: Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum]
  • Proportion of pregnant women with Gestational Diabetes [Срок оценки: Assessed between gestational age 36 and birth as well as between 1 to 3 months postpartum]
  • Postpartum depression [Срок оценки: One to three months postpartum]
  • Social support [Срок оценки: Assessed between gestational age 36 and birth]
  • Self-care [Срок оценки: Assessed between gestational age 36 and birth]
  • Collective Decision-making [Срок оценки: Assessed between gestational age 36 and birth]
  • Wish to use contraception [Срок оценки: One to three months postpartum]
  • Contraceptive plans [Срок оценки: One to three months postpartum]
  • Contraception use [Срок оценки: One to three months postpartum]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Somalia · 1 центр
  • University of Hargeisa — Hargeisa

Идентификаторы

NCT: NCT07438379 · PROMISE_Study_Hargeisa_477/6

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗