Effect of oral high dose Vitamin B12 on pregnancy outcomes
Not Applicable
Completed
- Registration Number
- CTRI/2015/05/005787
- Lead Sponsor
- ICMR DHR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1920
Inclusion Criteria
Only the married, non-pregnant females who are planning a pregnancy and willing to take drugs as required in the intervention arm or control arm for treatment of anemia will be recruited.
Exclusion Criteria
Those reproductive age group females, who are using any mode of contraception, or in lactational amenorrhea, or are diagnosed as infertile, will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The outcome measure will be <br/ ><br>Adverse Pregnancy Outcomes which will include any one of the following: <br/ ><br>Adverse Events (AE) <br/ ><br>oInfertility <br/ ><br>oPreterm delivery <br/ ><br>oIntrauterine growth retardation <br/ ><br>oIntrauterine growth retardation <br/ ><br>oNeonatal complications requiring admission in hospital <br/ ><br>oAbortion or threatened abortion requiring treatment <br/ ><br>oHyperemesis gravidarum requiring treatment <br/ ><br>oGestational Diabetes <br/ ><br>oGestational HTN/Preeclampsia/ecclampsia/HELLP syndrome diagnosed by an obstetrician <br/ ><br>Timepoint: Each trimester of pregnancy <br/ ><br>At termination of pregnancy <br/ ><br>1 month after delivery
- Secondary Outcome Measures
Name Time Method noneTimepoint: none