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临床试验/CTRI/2025/12/098428
CTRI/2025/12/098428尚未招募不适用

Effect of maternal zinc supplementation on pregnancy complications and outcomes - A Randomized Controlled Trial in a Tertiary Care Hospital

MRU1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年12月16日最近更新:

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

发起方
MRU
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DrGSridevi

Rangaraya medical college

研究点 (1)

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