Misoprostol+Oxytocin vs. Carbetocin in CS (CS)

July 7, 2020 updated by: Mohamed S Sweed, MD, Ain Shams University

Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section

This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

Exclusion Criteria:

  • hypersensitivity to oxytocin, carbetocin or prostaglandins
  • contraindication to prostaglandins (e.g. glaucoma)
  • history of significant heart disease
  • severe asthma
  • epilepsy
  • history or evidence of liver
  • renal or vascular disease
  • history of coagulopathy
  • thrombocytopenia or anticoagulant therapy
  • women with HELLP syndrome
  • eclampsia
  • women presenting by placental abruption
  • contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Misoprostol + Oxytocin
400 ug sublingual misoprostol + 10 IU Oxytocin IVI
Drug: Placebo
Drug: Oxytocin
Other Names:
  • Syntocinon
Drug: Misoprostol
Other Names:
  • Mesotac
  • Mesotec
Active Comparator: Carbetocin
100 ug Carbetocin IV
Drug: Placebo
Drug: Carbetocin
Other Names:
  • Pabal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of blood loss
Time Frame: 24 hours
24 hours
incidence of post-partum hemorrhage
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)
Time Frame: 24 hours
An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.
24 hours
Number of participants needing hemostatic surgical interventions
Time Frame: intra-operative
intra-operative
Hemoglobin deficit in gm/dl
Time Frame: 24 hours
difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
24 hours
APGAR score at 1 minute and 5 minutes
Time Frame: 1 minute and 5 minutes
1 minute and 5 minutes
Number of participants with NICU admission
Time Frame: 24 hours
24 hours
Drug side effects
Time Frame: 24 hours
24 hours
Time till resuming bowel habits
Time Frame: 24 hours
Time of passing gas will be recorded how many hours post-operative
24 hours
hematocrit deficit in %
Time Frame: 24 hours
difference between pre-operative and 24 hours post-operative hematocrit in %
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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