Comparison of Intravenous Labetalol and Intravenous Hydralazine in Severe Preeclampsia

NCT07572656 | Completed

• 1 other identifier: Dr-Namra-QAMC
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

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

  6 hours

Study Arms (2)

Group-A

EXPERIMENTAL

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.

Drug: Labetalol

Group-B

EXPERIMENTAL

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.

Drug: Hydralazine

Interventions

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.

Group-A

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.

Group-B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Sadiq Abbasi Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Labetalol; Hydralazine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Namra Rasheed

  Sadiq Abbasi Hospital, Bahawalpur, Pakistan

  PRINCIPAL INVESTIGATOR

• Saba Nadeem, FCPS

  Sadiq Abbasi Hospital, Bahawalpur, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)