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A clinical trial to study the effect of two drugs, Labetalol and Nifedipine, in women with hypertensive disorder of pregnancy

Effectiveness of Oral Labetalol Versus Oral Nifedipine for Control of Hypertension in Postpartum Women with Hypertensive Disorders of Pregnancy- A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088334
Enrollment
88
Registered
2025-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: O135- Gestational [pregnancy-induced] hypertension without significant proteinuria, complicating the puerperium

Interventions

Intervention1: Group B-Postpartum women receiving oral Nifedipine: Nifedipine will be started at 10 mg BD initially, and then the dose will be increased not more than 60 mg/day till 6 weeks Control I

Sponsors

Department of Obstetrics and Gynaecology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women having persistent postpartum hypertension with BP more than 150 by 100 mmHg up to 160 by 110 mmHg. 2. Women delivered at the gestational age of more than 24 weeks. 3. Women willing to follow up for up to 6 weeks. 4. Women willing to participate in the study. 5. Postpartum women having gestational hypertension, pre-eclampsia, chronic hypertension, and de novo postpartum hypertension.

Exclusion criteria

Exclusion criteria: 1. Women allergic to nifedipine or labetalol. 2. Women with a heart rate less than 60 beats per minute or more than 110 beats per minute. 3. Women having cardiac disease. 4. Women having renal disease with serum creatinine level more than 1 mg per dl. 5. Women having uncontrolled diabetes mellitus, bronchial asthma, and eclampsia.

Design outcomes

Primary

MeasureTime frame
Blood pressure measurementTimepoint: Serial blood pressure measurements will be done hourly for the first 6 hours, and then 4 hourly for the next 24 hours, and then follow-up will be taken after 2 weeks, and then after 6 weeks

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Kanchan Dwidmuthe

NKP Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital , Nagpur

kanchandwidmuthe@gmail.com08237659529

Outcome results

None listed

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