Uterotonics for Severe Preeclampsia | NCT04756661

Studies
Uterotonics for Severe Preeclampsia

NCT04756661

Sponsor

Assiut University

Status

Completed

Last Update Posted

Feb 16, 2021Actual

Enrollment

124Actual

Phase

Not Applicable

Conditions

Preeclampsia Severe

Interventions

Carbetocin
Oxytocin
Misoprostol

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Feb 10, 2021Actual

First Submitted Date

Feb 12, 2021

First Submission Date that Met QC Criteria

Feb 12, 2021

First Posted Date

Feb 16, 2021Actual

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

Feb 12, 2021

Last Update Posted Date

Feb 16, 2021Actual

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

The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbetocin	Experimental	Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.	Drug: Carbetocin
Oxytocin plus misoprostol	Active Comparator	Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.	Drug: Oxytocin Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carbetocin	Drug	100 mcg of Carbetocin intravenous injection	Carbetocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of postpartum hemorrhage more than 1000 ml	the amount of bleeding during and after CS	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women which diagnosed with severe pre-eclampsia.
Singleton pregnancy.
Termination of pregnancy by Cesarean section after 28 weeks of gestation.

Exclusion Criteria:

Suspected or proven placental abruption.
Known placenta Previa or acreata.
Multiple pregnancies.
Obesity (BMI >35).
Anemia (<9 g/dl).
Retained placental tissues.
Big baby (> 4 kg).
Presence of coagulopathy.
Polyhydramnios.
Presence of Uterine fibroids.
Medical diseases as; cardiac, liver, renal or endocrine diseases.
General anesthesia.

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut Faculty of Medicine		Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C020731	carbetocin
D010121	Oxytocin
D016595	Misoprostol

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

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Browse Branches

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