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Oral antihypertensive regimens for management of hypertension in pregnancy

Oral antihypertensive regimens for management of hypertension in pregnancy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/08/003866
Enrollment
671
Registered
2013-08-02
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- Hypertension in pregnancy Health Condition 2: O268- Other specified pregnancy relatedconditions

Interventions

Intervention1: Oral methyldopa: Oral myethyldopa 1000mg every 6h for up to 6 hours Intervention2: Labetalol: Oral labetalol 200mg. If BP exceeds 155mmHg systolic or 105mmHG diastolic after 1h, an addi

Sponsors

Gynuity Health Projects
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Pregnant gestational age > 28 weeks • Systolic blood pressure >160 mm Hg OR a diastolic blood pressure of >110 mm Hg measured twice more than 15 minutes apart • Able to swallow pills • > 18 years

Exclusion criteria

Exclusion criteria: • Indication for emergent cesarean or known fetal anomaly • Anti-hypertensive therapy received in the past 6 hours • History of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy • Actively wheezing at time of enrollment or history of asthma complications • Known coronary artery disease or type I DM with microvascular complications

Design outcomes

Primary

MeasureTime frame
Successful outcome will be considered blood pressure that reaches the target (defined as 130-150mmHg systolic and 80-100 mmHg mm Hg diastolic) at 6h without an adverse outcome. Adverse outcomes include hypotension (systolic blood pressure, 120 mm Hg and/or diastolic blood pressure 70 mm Hg and fetal compromise), caesarean section for fetal distress, severe headache and severe headache requiring discontinuation of drug, or eclampsia.Timepoint: Six hours after drug administration

Secondary

MeasureTime frame
â?¢ the number of hourly BPâ??s in severe rangeTimepoint: every hour after drug administration

Countries

India

Contacts

Public ContactShuchita Mundle
srmundle@gmail.com9822706087

Outcome results

None listed

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