Prevention of Postpartum Haemorrhage | NCT04463966

Studies
Prevention of Postpartum Haemorrhage

NCT04463966

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Jul 9, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Post Partum Hemorrhage

Interventions

Tranexamic acid 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

Jul 2020

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 30, 2020Actual

Primary Completion Date

Apr 2021Estimated

Completion Date

May 2021Estimated

First Submitted Date

Apr 30, 2020

First Submission Date that Met QC Criteria

Jul 8, 2020

First Posted Date

Jul 9, 2020Actual

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

Jul 8, 2020

Last Update Posted Date

Jul 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Detailed Description

This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study	Active Comparator	Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .	Drug: Tranexamic acid injection
Control	No Intervention	control group will not be given tranexamic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic acid injection	Drug	1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .	Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood loss	Estimation of blood loss	immediately after deliver

Secondary Outcomes

Measure	Description	Time Frame
blood pressure	blood pressure	immediately after delivery
pulse	pulse	immediately after delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women at high risk for postpartum hemorrhage after cesarean section

Exclusion Criteria:

women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aboubakr Elnashar, MD	Contact	00201066934749		elnashar53@hotmail.com
shaimaa ezzat	Contact	00201009023289

Overall Officials

Name	Affiliation	Role
Shaimaa Ezzat	Police Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Police Hospital	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid

Ancestor Terms

ID	Term
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided