Role of supplementation of Vitamin D in prevention of preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Preeclampsia
研究概览
简要总结
The study will be conducted in the Department of Obstetrics and Gynecology and Department of Biochemistry at Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital, New Delhi. It will be a Prospective case control type of study. Duration of the study will be from 11th June 2025 to 10th November 2026.Sample size -In a study A prospective comparative interventional study by by Sinha et al. (2019)22 in Bhagalpur, Bihar, involved 60 pregnant women divided into two groups. The incidence of preeclampsia was 16.7 percent in the non-supplemented group compared to 6.7 percent in the vitamin D supplemented group, indicating a significant reduction in risk (p equal to 0.041) . Based on the formula and values given above, the sample size calculated per group is approximately 267 (total 534). Thus, with 80 percent power and 95 percent confidence interval, the minimum sample size required for the study is 267 in each group (total 534). It is proposed to recruit 125 pregnant women in each group (case and control groups) as a convenient sample size, which makes a total of 250.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Primigravida with singleton,low risk pregnancy 2.Gestational age between 14-18 weeks, confirmed by LMP or early ultrasound 3.Age between 18 to 35 years 4.Willing to give informed consent and comply with study procedures.
排除标准
- •History of preeclampsia or eclampsia in previous pregnancies.
- •Multiple pregnancy e.g. twins, triplets.
- •Chronic medical disorders including Chronic hypertension, pre existing diabetes mellitus, Chronic renal disease, autoimmune disorders such as SLE.
- •Malabsorption syndromes eg.
- •Celiac disease, crohn’s disease.
- •Severe anemia Hb less than 7 g per dl.
- •Parathyroid disorders or other endocrine disorders affecting calcium or vitamin D metabolism.
- •Known fetal anomalies detected via ultrasound.
结局指标
主要结局
Preeclampsia
时间窗: At 14-18 weeks followed by monthly till delivery
次要结局
- Gestational age at delivery,mode of delivery ,APGAR,birth(weight,admission in NICU.)
研究者
Dr Saumya Singh
ABVIMS Dr Ram Manohar Lohia Hospital
