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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
NameTimeMethod
Primary outcome measure includes incidence of preeclampsia/eclampsia, early onset preeclampsia.in third trimester of pregnancy, and early postpartum period
Secondary Outcome Measures
NameTimeMethod
Maternal and fetal complicationsSystolic and Diastolic function

Trial Locations

Locations (1)

JIPMER

🇮🇳

Pondicherry, PONDICHERRY, India

JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Nivedita
Principal investigator
09487581663
dr.niveditajha@gmail.com

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