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Improving pregnancy outcomes by treating severe high blood pressure using Iv Labetalol and Iv Hydralazine

A comparative study of Intravenous Labetalol and Intravenous Hydralazine for management of Severe hypertension in Pregnancy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095943
Enrollment
60
Registered
2025-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: O10-O16- Edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium Health Condition 2: O141- Severe pre-eclampsia

Interventions

Intervention1: INTRAVENOUS LABETALOL: Subjects receive Labetalol 20 mg in 100ML NS infusion. The blood pressure will be measured after 5 min, and if the BP is still found to be high(i.e. BP more 160/1

Sponsors

DR SOUMYA DANDIN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consenting pregnant women of age more than or equal to 18 years with systolic blood pressure more than or equal to 160 mmHg or Diastolic blood pressure (DBP) more than or equal to 110 mmHg like gestational Hypertension, preeclampsia, chronic Hypertension, chronic Hypertension with superimposed preeclampsia , with gestational period above 28 weeks.

Exclusion criteria

Exclusion criteria: 1.Multiple pregnancies 2.Women with known allergy to Hydralazine or Labetalol. 3.Women with idiopathic systemic lupus erythematosus or related diseases. 4.Women with myocardial insufficiency due to mechanical obstruction (ex-aortic or mitral stenosis or constrictive pericarditis). 5.Women with isolated right ventricular heart failure due to pulmonary Hypertension (cor pulmonale). 6.Women with dissecting aortic aneurysm. 7.Intrauterine death

Design outcomes

Primary

MeasureTime frame
The effectiveness of the two intravenous drugs, Hydralazine and Labetalol, in the management of severe Hypertension in pregnancy with respect to lowering blood pressureTimepoint: 5min 10min 15min 30 min 1hr 2hr 3hr 4hr 5 hr and 6 hours—

Secondary

MeasureTime frame
The maternal outcomes with Inj Hydralazine and Inj Labetolol with respect to heart rate, BP, any adverse outcome and need for additional antihypertensive therapy.Timepoint: 5min 10min 15min 30 min 1hr 2hr 3hr 4hr 5 hr and 6 hours;Other adverse outcomes with respect to the drug.Timepoint: 24 HRS—

Countries

India

Contacts

Public ContactDR RAJASRI G YALIWAL

BLDE(DU) Shri B M Patil Medical College, Hospital, and Research Institute , Vijayapura

ryaliwal@bldedu.ac.in9845152240

Outcome results

None listed

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