Effect of maternal zinc supplementation on pregnancy complications and outcomes - A Randomized Controlled Trial in a Tertiary Care Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- MRU
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Low Birth weight
研究概览
简要总结
· All the eligible pregnant women were screened for Zn levels, those below normal Reference range.
· Investigator will provide monthly supply of zinc to the pregnant women and instructed the women to consume one tablet daily between meals and not together with other vitamin or mineral supplements. Compliance with this regimen was assessed by counting the remaining tablets in each strip at the next visit.
· Its A Randomized controlled Clinical Trial (double blinded) in Government general Hospital, Kakinada for a period of One year among Pregnant women who are attending OBG OPD, GGH, Kakinada.
· Pregnant women carrying a singleton foetus, at 12–16 wks of gestation , willing to have their delivery in Kakinada and provided informed written consent will be included. Having History of renal disease, hypertension and diabetes were excluded
· Pregnant women would be consecutively assigned into study and control group. Zn estimation was done at the time of enrollment, at 28wks of gestation and at the time of delivery (3times). For The intervention arm Zinc supplementation would be given at the time of enrollment into the study and continued till delivery (maximum of 28wks)-30mg elemental Znso4/day .
· Maternal outcome Measures: PIH, Pre-eclampsia, premature rupture of membrane, APH, PPH, caesarean, instrumental delivery
· Neonatal Outcome Measures : Stillbirth, neonatal death, preterm birth , small for gestational age (SGA), low birth weight (LBW), length and head circumference, 5-minute APGAR score , MUAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women coming to Antenatal OPD on alternate day carrying a singleton foetus and 12–16 weeks of gestation with no history of renal disease hypertension diabetes.
- •willing to have their delivery in Government General hospital Kakinada and willing to provide informed written consent will be included in the study.
排除标准
- •History of renal disease, hypertension and diabetes.
结局指标
主要结局
Low Birth weight
时间窗: Low Birth weight at the time of delivery
次要结局
- PIH(premature rupture of membrane)
研究者
DrGSridevi
Rangaraya medical college
