Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ahmed Samy aly ashour，Cairo University

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

November 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

incidence of postpartum hemorrhage after CS[ Time Frame: 24 hours ]

Number of participants experienced massive postpartum hemorrhage

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

side effects of drugs used[ Time Frame: 24 hours ]
GIT side effects as nausea , vomiting

Descriptive Information

Brief Title ^ICMJE

Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Official Title ^ICMJE

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage in Obese Women Undergoing Elective Cesarean Delivery

Brief Summary

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Detailed Description

A double blind randomized study conducted on 400 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (200 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (200 women) after fetal extraction and before placental removal. Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Drug: carbetocin
single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Drug: Syntometrine
received combination of 5 IU oxytocin (Syntocinon®, Novartis, Basel, Switzerland) and 0.2 mg ergometrine (Methergin®,Novartis).

Study Arms

Experimental: carbetocin
200 women received single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
Active Comparator: Syntometrine
200 women received combination of 5 IU oxytocin (Syntocinon®, Novartis, Basel, Switzerland) and 0.2 mg ergometrine (Methergin®,Novartis).

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

400

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 1, 2018

Estimated Primary Completion Date

November 30, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - All participants are at 37 - 40 weeks of gestational age - Noncomplicated pregnancy. - obese women with BMI > 30. Exclusion Criteria: - Participants with placenta previa, - coagulopathy, - preeclamptic - known sensitivity to carbetocin,oxytocin or methergine were excluded

Sex/Gender

Sexes Eligible for Study:

Female

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ahmed Samy aly ashour，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: AHMED SAMY, MD Cairo University

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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