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Comparison of safety and efficacy of Nifedipine versus Labetalol

"A Randomized Parallel Group Trial For Comparison of safety and efficacy of oral nifedipine versus IV labetalol in Rx of hypertensive emergencies of pregnancy."

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053461
Enrollment
104
Registered
2023-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: O141- Severe pre-eclampsia Health Condition 2: O169- Unspecified maternal hypertension,unspecified trimester

Interventions

Intervention1: oral nifedipine versus intravenous labetalol: oral nifedipine retard 20mg initially followed by repeated doses of 20mg every 30minutes maximum of 5 doses till the target bp is reached.

Sponsors

CHETHY SUDEEPTHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with antihypertensive emergencies [severe pre-eclampsia/ Imminent eclampsia Maternal age above 18 years. Gestational age >28 weeks.

Exclusion criteria

Exclusion criteria: other medical disorders except hypertension. Women in active labour. Received any other anti hypertensive prior to admission. Intrauterine death Eclampsia

Design outcomes

Primary

MeasureTime frame
To know the safety and efficacy of the drug and route.Timepoint: The time required to achieve the outcome is 1 week.—

Secondary

MeasureTime frame
Total antihypertensives required to achieve target blood pressure and need for additional antihypertensive drug. Mode of delivery complications associated with drugs effect like hypotension,headache,tachycardia are to be analysedTimepoint: specific time required to achieve outcome is 1 week.—

Countries

India

Contacts

Public ContactCHETHY SUDEEPTHI

SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

aruna.biradar@bldedu.ac.in8197191472

Outcome results

None listed

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