NCT06360601

Brief Summary

We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

December 2, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

March 31, 2024

Last Update Submit

November 26, 2024

Conditions

Preeclampsia Severe

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    Mean cerebral blood flow and cerebral perfusion pressure

    Pre intervention-after one hour of intervention

Study Arms (2)

Labetalol group

ACTIVE COMPARATOR
Drug: Labetalol Injection

Hydralazine group

ACTIVE COMPARATOR
Drug: HydrALAZINE Injection

Interventions

Labetalol InjectionDRUG

Labetalol intravenous infusion 20ml/hr

Labetalol group
HydrALAZINE InjectionDRUG

Hydralazine intravenous infusion 5mg/hr

Hydralazine group

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale as it get pregnant
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patient with clinical diagnosis of sever preeclampsia

You may not qualify if:

  • Patient with history of previous intracranial lesion Patient with history of heart disease/allergy to drug Patient with history of arrhythmia/anticoagulation Any craniotemporal lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta Univeristy hospitals

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

LabetalolHydralazine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesPhthalazinesPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

shimaa zahraa

CONTACT

201550273707Meikamal89@outlook.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anaesthesia

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 11, 2024

Study Start

April 1, 2024

Primary Completion

November 20, 2024

Study Completion

December 20, 2024

Last Updated

December 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Locations

EG(1)