Vitamin D Supplementation Among Pregnant Women in Uganda and for the Prevention of Adverse Obstetric Outcomes: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,980
- 主要终点
- The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome.
研究概览
简要总结
The goal of this randomised controlled trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
The main question it aims to answer is if Vitamin D supplementation, administered as oral vitamin D₃ at a dose of 2,000 IU once daily, from the time of recruitment to the time of delivery, reduces the incidence of preeclampsia, eclampsia and HELLP syndrome in pregnant women attending ANC at St. Mary's Hospital, Lacor, such incidence being monitored up to six (6) weeks after delivery.
Researchers will compare the effect of oral 2.000 IU vitamin D daily (intervention group) vs. oral placebo daily (control group) on the prevalence of adverse maternal and foetal outcomes.
详细描述
Introduction:
Vitamin D deficiency is a global health issue, with an estimated prevalence in Africa of about 34%. Black pregnant and breastfeeding women are among the populations with the highest risk of deficiency, with a prevalence of up to 40% in urban Uganda.
Low Vitamin D status in pregnancy seems to be associated with multiple adverse obstetric outcomes, in particular with hypertensive disorders in pregnancy, gestational diabetes, severe postpartum haemorrhage, preterm birth, and low birth weight; these associations have been studied predominantly in Caucasian populations. Recent studies investigated Vitamin D supplementation in preventing preeclampsia, which is known to be more prevalent and severe in dark-skinned women, but results from Africa are scanty; little data have been published on the supplementation of vitamin D in pregnant women in sub-Saharan countries, including Uganda.
Objective: The objective of this trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
Methods: This will be a double-blinded randomized trial with parallel groups, where pregnant women attending ANC at St. Mary's Hospital, Lacor (Gulu, Northern Uganda), enrolled at gestational age between 13 and 27 weeks, confirmed by ultrasonography at the first antenatal visit, will be invited to participate. Enrolment is planned to start in the last quarter of 2025 and will last approximately 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of age ≥ 18 years, who attend ANC services at St. Mary's Hospital Lacor, satisfying the following criteria:
- •with a viable intrauterine pregnancy,
- •at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days, and
- •who consented to participate in the study.
排除标准
- •women already on Vitamin D treatment prescribed by a physician.
研究组 & 干预措施
Intervention group
Participants will receive oral 2.000 IU vitamin D daily
干预措施: oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations (Drug)
Control group
Participants will receive an oral placebo daily
干预措施: Placebo (Other)
结局指标
主要结局
The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome.
时间窗: From enrolment to 6 weeks postpartum
For each participant, the first occurrence of preeclampsia, eclampsia, or HELLP syndrome during pregnancy will be considered for the primary analysis. The criteria for preeclampsia, eclampsia, or HELLP syndrome are reported in the Operational Definitions of the Study Protocol
次要结局
- The occurrence of maternal Gestational Hypertension (GH)(From enrolment to 6 weeks postpartum)
- Fatal outcome of delivery (live birth or stillbirth), with APGAR score at 1 and 5 minutes(At delivery, at 1 minute and 10 minutes after birth)
- Preterm birth, i.e., Gestational Age at delivery < 37 weeks(At delivery)
- Mode of delivery(At delivery)
- Admission to HDU or ICU(From enrolment to 6 weeks postpartum)
- New-born birth weight(At delivery)
- Foetal sex and malformations(At delivery)
- New-born admission to Nursery or Neonatal Intensive Care Unit (NICU)(From delivery to 6 weeks postpartum)
- The occurrence of maternal Gestational Diabetes (GDM)(From enrolment to delivery)
- The occurrence of maternal Antepartum Haemorrhage (APH)(From 28 weeks of Gestational Age to delivery)
- The occurrence of Primary Postpartum Haemorrhage (1.PPH)(From delivery to 24 hours post delivery)
- The occurrence of Prelabour Rupture of Membranes (PROM)(From enrolment to delivery)