Determination of Blood Loss After CS | NCT04549012

Studies
Determination of Blood Loss After CS

NCT04549012

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Sep 16, 2020Actual

Enrollment

130Estimated

Phase

Early Phase 1

Conditions

Effect of Drug

Interventions

Tranexamic acid
Oxytocin

Countries

Not provided

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2020Estimated

Primary Completion Date

Sep 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Sep 9, 2020

First Submission Date that Met QC Criteria

Sep 14, 2020

First Posted Date

Sep 16, 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

Sep 14, 2020

Last Update Posted Date

Sep 16, 2020Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS

Detailed Description

tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A	Active Comparator	will receive oxytocin	Drug: Oxytocin
group B	Active Comparator	will receive tranexamic acid plus oxytocin	Drug: Tranexamic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranexamic acid	Drug	comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS	group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amount of blood loss	comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS	baseline

Secondary Outcomes

Measure	Description	Time Frame
maternal and neonatal complication	blood transfusion ,surgical injuries ,	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age : 20-40 year
- 2- Gestational age is between 37-41weeks

3- Delivery by uncomplicated elective CS

Exclusion Criteria:

1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
noha abu shata	Contact	01000287839		mhmwdnhy44@gmail.com
tamer Borg	Contact	01001457437		tamerborg1975@gmail.com

Overall Officials

Not provided

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014148	Tranexamic Acid
D010121	Oxytocin

Ancestor Terms

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

Browse Leaves

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Browse Branches

Not provided