Role of Vitamic C and E in high blood pressure during pregnancy
Phase 3
Recruiting
- Conditions
- Mild to moderate pre-eclampsia,
- Registration Number
- CTRI/2021/03/032346
- Lead Sponsor
- JIPMER pONDICHERRY
- Brief Summary
Pregnant women at high risk for developing preeclampsia will be randomized to receive Vitc (1000 mg) and Vit E (400 IU) or placebo (crystalline dextrose). Women will be watched for development of preeclampsia, maternal and fetal complications. Additionally, echocardiographic parameters will be obtained to find the effect of antioxidant on systolic and diastolic function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 721
Inclusion Criteria
- Inclusion criteria: Pregnant women presenting in antenatal clinic of JIPMR between 14- 22 weeks of gestation with one or more risks factors a.
- preeclampsia/eclampsia in previous pregnancy, b.
- chronic hypertension, c.
- renal disease, d.
- HELLP syndrome in prior pregnancy, e.
- pregestational diabetes, f.
- women with BMI 30 kg/m2, g.
- antiphospholipid syndromes, h.
- multifetal pregnancy, i.
- thrombophilia, j.
- Assisted reproductive technique conception, k.
- age more than 35 years.
Exclusion Criteria
- Exclusion criteria: 1.
- Pregnant women less than 18 years 2.
- Women with known cardiac lesion 3.
- Women with known chronic respiratory disease (Tuberculosis, COPD, Bronchial asthma) 4.Women receiving warfarin therapy 5.Women unable to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure includes incidence of preeclampsia/eclampsia, early onset preeclampsia. in third trimester of pregnancy, and early postpartum period
- Secondary Outcome Measures
Name Time Method Maternal and fetal complications Systolic and Diastolic function
Trial Locations
- Locations (1)
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
JIPMER🇮🇳Pondicherry, PONDICHERRY, IndiaNiveditaPrincipal investigator09487581663dr.niveditajha@gmail.com