Role of Vitamin D in Prevention of Preeclampsia Recurrence in Pregnant Women With Previous History of Preeclampsia: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Pre-eclampsia
研究概览
简要总结
The goal of this clinical trial is to find out whether giving vitamin D to pregnant women who had pre-eclampsia in a previous pregnancy helps prevent the condition from coming back. The main question it aims to answer is:
Does vitamin D supplementation reduce the chance of pre-eclampsia recurring in pregnant women with a history of pre-eclampsia?
To answer this question, pregnant women attending the antenatal clinic at the Department of Obstetrics and Gynaecology, Nishtar Hospital Multan will be invited to join the study.
Participants will be randomly assigned to two equal groups:
- Vitamin D group: will take 4,000 IU of oral vitamin D until 36 weeks of gestation.
- Placebo group: will receive a pill identical in appearance, taste, and consistency but without vitamin D.
While on the study medication, each woman will visit the clinic every two weeks. At each visit, her blood pressure will be measured, and if it is 140/90 mmHg or higher, a urine test will check for protein to identify pre-eclampsia as per hospital protocol. Any diagnosis of pre-eclampsia will lead to standard care, and the outcome will be recorded.
At the end, researchers will compare how many women in each group developed recurrent pre-eclampsia.
This study will help answer whether vitamin D supplementation can safely reduce the risk of pre-eclampsia returning in women with a prior history - a question important for improving pregnancy outcomes and maternal health.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 20-weeks (on LMP method) ' - Past medical history of pre-eclampsia
排除标准
- •Pre-existing hypertension, cardiac diseases, renal disease, thyrotoxicosis (on history and medical record)
- •Women presenting with intra-uterine death of the fetus.
研究组 & 干预措施
Intervention
Oral supplementation with high dose vitamin D
干预措施: Vitamin D (Drug)
Placebo
Placebo
干预措施: Placebo and standard of care (Drug)
结局指标
主要结局
Pre-eclampsia
时间窗: From enrollment till 36 completed weeks of gestation
Pregnant women, ≥ 20-weeks of gestation (on LMP method) having blood pressure of ≥140/90 mm of Hg plus protein (+1 or higher) in spot urine examination by dipstick method
次要结局
未报告次要终点
研究者
Dr. Tehseen Aslam
Principal Investigator
Nishtar Medical University
