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To study the effects of two different drugs for blood pressure control in women immediately after delivery

Labetalol versus Enalapril for the management of postpartum hypertension-An open label randomized control trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033252
Enrollment
300
Registered
2021-04-29
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: O10-O16- Edema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium

Interventions

Intervention1: Enalapril: Antihypertensive drug-Angiotensin converting enzyme inhibitor dose and frequency-starting dose 2.5 mg twice daily upto 10 mg twice daily. route of administration-oral duratio

Sponsors

Internal Fluid Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Postnatal women with new onset hypertension( blood pressure >= 140 mm Hg systolic or >=90mmHg diastolic) •Women who had been diagnosed with intrapartum hypertension, treated with single short acting antihypertensive , during postnatal monitoring found to have blood pressure >= 140 mm Hg systolic or >=90mmHg diastolic. •Women who had been on single antihypertensive before pregnancy which was stopped postnatally and later detected to have hypertension after the wash out period of first drug.

Exclusion criteria

Exclusion criteria: •Women with severe intrapartum hypertension or gestational hypertension requiring >=1 antihypertensives. •Women who were already on antihypertensive drugs antenatally and the same continued postnatally •Women with creatinine >1.4 mg/dl •Women with urine output •Women with known heart block, cardiac failure or heart rate •Allergy to labetalol or enalapril •Moderate, persistent or severe asthma •Women with hyperkalemia

Design outcomes

Primary

MeasureTime frame
â?¢To determine the proportion of women who would achieve adequate blood pressure control with the study drug. Timepoint: At the time of discharge

Secondary

MeasureTime frame
â?¢Percentage reduction in systolic BP â?¢Percentage reduction in diastolic BP â?¢Need for other oral antihypertensive drugs â?¢Need for intra venous antihypertensive drugs â?¢Post partum complications secondary to hypertensive disorders of pregnancy-acute pulmonary oedema/ eclampsia/oliguria â?¢Drug reactions Time taken to discharge from the hospital â?¢BP and Need for antihypertensives at 6 weeks â?¢BP and Need for antihypertensives at 12 weeksTimepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Kavitha Abraham

Christian Medical College

alphakavi@hotmail.com04162283899

Outcome results

None listed

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