Intravenous Labetalol Versus Hydralazine in Preeclampsia | NCT06360601

Studies
Intravenous Labetalol Versus Hydralazine in Preeclampsia

NCT06360601

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Dec 2, 2024Actual

Enrollment

40Estimated

Phase

Phase 1Phase 2

Conditions

Preeclampsia Severe

Interventions

Labetalol Injection
HydrALAZINE Injection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Nov 20, 2024Actual

Completion Date

Dec 20, 2024Estimated

First Submitted Date

Mar 31, 2024

First Submission Date that Met QC Criteria

Apr 7, 2024

First Posted Date

Apr 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2024

Last Update Posted Date

Dec 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Labetalol group	Active Comparator		Drug: Labetalol Injection
Hydralazine group	Active Comparator		Drug: HydrALAZINE Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Labetalol Injection	Drug	Labetalol intravenous infusion 20ml/hr	Labetalol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral blood flow	Mean cerebral blood flow and cerebral perfusion pressure	Pre intervention-after one hour of intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with clinical diagnosis of sever preeclampsia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female as it get pregnant

Minimum Age

25 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shimaa zahraa	Contact	201550273707		Meikamal89@outlook.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta Univeristy hospitals	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007741	Labetalol
D006830	Hydralazine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided