Effect of maternal zinc supplementation on pregnancy complications and outcomes - A Randomized Controlled Trial in a Tertiary Care Hospital
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- MRU
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Low Birth weight
Study Overview
Brief Summary
· 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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Double
Eligibility Criteria
- Ages
- 15.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •History of renal disease, hypertension and diabetes.
Outcomes
Primary Outcomes
Low Birth weight
Time Frame: Low Birth weight at the time of delivery
Secondary Outcomes
- PIH(premature rupture of membrane)
Investigators
DrGSridevi
Rangaraya medical college
