Does Vitamin D supplementation in pregnancy improves maternal and neonatal outcome?
Not Applicable
Completed
- Registration Number
- CTRI/2015/07/006039
- Lead Sponsor
- CMS and GTB Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 484
Inclusion Criteria
Primigravida at 16-24 weeks of gestation (by L.M.P. Method)at the time of enrollment
Exclusion Criteria
1. Age <18 yrs & >30 yrs
2. Multiple pregnancy
3. Extreme malnutrition (BMI >35 & <12 kg/m2)
4. Patients having B.P. Systolic >130 or Diastolic >90 mmHg
5. Patients presenting with preeclampsia,antepartum haemorrhage
6. History of past chronic medical illnesses & drug history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison between the groups for the incidences of <br/ ><br>I) Adverse maternal outcomes: <br/ ><br> - Gestational Hypertension <br/ ><br> - Preeclampsia <br/ ><br> - Spontaneous preterm rupture of membranes <br/ ><br>II) Adverse neonatal outcomes: <br/ ><br> - Preterm birth <br/ ><br> - Small for gestational age newborn <br/ ><br>III) 25(OH) D levels of those who develop complications to those who do not develop complications <br/ ><br>Timepoint: at the time of delivery
- Secondary Outcome Measures
Name Time Method (a) Reduction in incidence of <br/ ><br> 1 - Maternal deaths <br/ ><br> 2- Maternal admissions to ICU <br/ ><br>3 - Still Birth <br/ ><br>4 - Early neonatal deaths ( 7days ) <br/ ><br>(b) Improvement in <br/ ><br>1 - Apgar score at 1 min and 5 min of birth <br/ ><br>Timepoint: within 7 days of delivery