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NCT Number: NCT07572656

Comparison of Intravenous Labetalol and Intravenous Hydralazine in Severe Preeclampsia

Due to limited data regarding preeclampsia from the local population, the debate is still ongoing in the study setting. Hence, the current study was planned to compare the efficacy of labetalol and hydralazine for the treatment of hypertension in patients with severe preeclampsia.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sadiq Abbasi Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

About this study

As preeclampsia is associated with high perinatal mortality and morbidity, the choice of a better antihypertensive in pregnancy is still debatable. The findings of this study would help evaluate the more efficacious drug between intravenous labetalol and intravenous hydralazine in the management of severe preeclampsia. Based on this empirical evidence, practical recommendations can be developed for routine practice guidelines regarding the optimal drug choice between the two for treating severe preeclampsia and eventually to reduce perinatal mortality and morbidity for both the mother and fetus.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women
  • Both primiparous and multiparous women
  • Aged 20-35 years
  • Gestational age ≥20weeks (assessed on last menstrual period)
  • With severe preeclampsia

Exclusion criteria

  • Known allergy to hydralazine or labetalol
  • Deranged liver function tests due to any other cause
  • Women with pre-existing hypertension systolic blood pressure ≥130 mmHg, diastolic blood pressure ≥80 mmHg
  • Patients receiving more than one antihypertensive drug since admission
  • Women with chronic renal failure

Treatment and study plan

labetalol

Drug

Patients were given a 20 mg bolus dose of labetalol in 2 minutes, and blood pressure was checked after 20 minutes; if not effective, then a 40 mg dose of labetalol was given. If still no effect was seen, then 80 mg was given every 20 minutes up to a maximum dose of 300 mg, and every time blood pressure was checked after 20 minutes.

Hydralazine

Drug

Patients were given intravenous hydralazine, 5 mg in a bolus dose, then repeated every 20 minutes as needed up to five doses; a maximum of 25 mg was given.

Primary outcomes

  1. Treatment efficacy

    Time frame: 6 hours

    The efficacy was labeled as 'yes' if a blood pressure of 140/90 was achieved, frequency of patients was noted.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Comparison of the Efficacy of Intravenous Labetalol and Intravenous Hydralazine for the Treatment of Hypertension in Patients With Severe Preeclampsia.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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