A study to compare tablet Nifedipine and Injection Labetalol to treat severe high blood pressure in pregnancy

A study of efficacy of oral nifedipine and intravenous labetalol for acute hypertensive crisis in pregnancy A Randomised control trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112065

Enrollment

Registered

2026-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: O169- Unspecified maternal hypertension,unspecified trimester Health Condition 2: O169- Unspecified maternal hypertension,unspecified trimester

Interventions

Intervention1: NIFEDIPINE: Participants receive an oral capsule of 10 mg Nifedipine The dose is repeated every 30 min if the target blood pressure is not achieved A maximum of five doses total 50 mg c

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy with gestational age more than or equal to 28 weeks. Diagnosed with hypertension during pregnancy (gestational hypertension, preeclampsia, or eclampsia). Presenting with an acute rise in blood pressure more than or equal to 160/110 mmHg, regardless of prior antihypertensive treatment. Informed consent will be obtained from all participants (or relatives, if unconscious) to ensure ethical and voluntary participation

Exclusion criteria

Exclusion criteria: Pre-existing renal or liver disease (possible secondary hypertension). Pulmonary oedema (risk worsened by nifedipine). Asthma, obstructive lung disease, or cardiac conditions (contraindicated with labetalol). Known allergy to nifedipine or labetalol.

Design outcomes

Primary

Measure	Time frame
Time taken to achieve the target blood pressure less than or equal to 140 by 90 mmHg or a 20 to 25 percent reduction in mean arterial pressure from baselineTimepoint: Maternal monitoring of blood pressure post intervention every 30 minutes till the target BP or MAP is achieved and thereafter for a period of 48 hrs blood pressure will be checked before intervention after 30 minutes after 60 minutes after 90 minutes after 120 minutes after 180 minutes after intervention	—

Measure

Time frame

Time taken to achieve the target blood pressure less than or equal to 140 by 90 mmHg or a 20 to 25 percent reduction in mean arterial pressure from baselineTimepoint: Maternal monitoring of blood pressure post intervention every 30 minutes till the target BP or MAP is achieved and thereafter for a period of 48 hrs blood pressure will be checked before intervention after 30 minutes after 60 minutes after 90 minutes after 120 minutes after 180 minutes after intervention

—

Secondary

Measure	Time frame
To compare the efficacy of oral nifedipine & intravenous labetalol in lowering blood pressure during acute hypertensive crisis during pregnancy.Timepoint: blood pressure will be checked before intervention after 30 minutes after 60 minutes after 90 minutes after 120 minutes afte 180 minutes of intervention	—

Countries

India

Contacts

Public ContactDr Janani B

S Nijalingappa medical college and HSK hospital and research centre Bagalkot

dr.nagarathnakuntoji@gmail.com9845058371

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026