Comparison of Intravenous Labetalol and Intravenous Hydralazine in Severe Preeclampsia

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07572656

Enrollment

132

Registered

2026-05-07

Start date

2024-05-01

Completion date

2024-10-31

Last updated

2026-05-07

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

Conditions

Preeclampsia

Brief summary

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.

Detailed description

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.

Interventions

DRUGLabetalol

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.

DRUGHydralazine

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment efficacy	6 hours	The efficacy was labeled as 'yes' if a blood pressure of 140/90 was achieved, frequency of patients was noted.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORNamra Rasheed

Sadiq Abbasi Hospital, Bahawalpur, Pakistan

STUDY_DIRECTORSaba Nadeem, FCPS