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

Effect of prophylactic isosorbide mononitrate on the incidence of preeclampsia in high risk women â?? A double blind randomized controlled trial. - NOPE (Nitric Oxide in Prevention of pre-Eclampsia) Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003251
Enrollment
100
Registered
2012-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Intervention1: ISMN (Isosorbide Mononitrate) and Aspirin: Dose : ISMN 20mg
Aspirin 75mg Frequency: Once daily Duration: From 16 weeks gestation till delivery Route of administration: oral Control Intervention1: Aspirin & Placebo: Dose: Aspirin 75mg
Placebo tablet Frequency: Once daily Duration: From 16 weeks gestation till delivery Route of administration: Oral

Sponsors

Jawaharlal Institute of Post graduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

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. â?? 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

Exclusion criteria: 1. Women with h/o heart disease (congenital heart disease, valvular heart disease, ischemic heart disease) 2. Women with Hb 3. Multi-fetal gestations 4. Diabetes, Chronic Renal/Liver disease, Epilepsy 5. Women with history of allergy to ISMN

Design outcomes

Primary

MeasureTime frame
Incidence of Gestational hypertension / Pre eclampsiaTimepoint: Till delivery—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactManikandan

Jawaharlal Institute of Post graduate Medical Education and Research

ponsganesan@gmail.com04132296275

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026