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Study on the role of nitrate in the prevention of high blood pressure due to pregnancy

Not Applicable
Conditions
Health Condition 1: null- Pregnant women who have high risk of developing hypertensive disorders of pregnancy such as pre-eclampsia, eclampsia and gestational hypertension.
Registration Number
CTRI/2012/12/003251
Lead Sponsor
Jawaharlal Institute of Post graduate Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Women with one high risk factor / two or more moderate risk factors as given below

High risk factors:

1. Previous pregnancy with h/o hypertensive disorders (pre-eclampsia, eclampsia, gestational hypertension, chronic hypertension), IUGR, abruption.

2. Chronic hypertension

3.Chronic kidney disease

4. Autoimmune diseases such as SLE, antiphospolipid antibody syndrome.

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Moderate risk factors:

1.First pregnancy

2.Pregnancy interval > 10 years

3.BMI >35/m2 at first visit

4.Age >40 years

5.Family h/o Pre eclampsia.

Exclusion Criteria

1. Women with h/o heart disease (congenital heart disease, valvular heart disease, ischemic heart disease)

2. Women with Hb < 8 g/dl

3. Multi-fetal gestations

4. Diabetes, Chronic Renal/Liver disease, Epilepsy

5. Women with history of allergy to ISMN

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of Gestational hypertension / Pre eclampsiaTimepoint: Till delivery
Secondary Outcome Measures
NameTimeMethod
Anti hypertensive drug usedTimepoint: Till delivery;Birth weightTimepoint: at delivery;Gestational age at birthTimepoint: Till delivery;Maternal MorbidityTimepoint: Hospital stay;Neonatal complicationsTimepoint: Till discharge;Neonatal deathsTimepoint: Till discharge;Nicu admissionsTimepoint: Till discharge;Severity of preeclampsiaTimepoint: Discharge from hospital after delivery;StillbirthsTimepoint: Till discharge;Time of onset of Gestational hypertension/PreeclampsiaTimepoint: Discharge from hospital after delivery
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