Uterotonics for Severe Preeclampsia

February 12, 2021 updated by: Ahmed Mohamed Abbas, Assiut University

Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

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
      • Assiut, Egypt
        • Assiut Faculty of Medicine

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Carbetocin
Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby.
Drug: Carbetocin
100 mcg of Carbetocin intravenous injection
ACTIVE_COMPARATOR: Oxytocin plus misoprostol
Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia.
Drug: Oxytocin
10 IU oxytocin IV drip
Drug: Misoprostol
400 mcg rectal

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Assiut 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 (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

February 10, 2021

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (ACTUAL)

February 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARBOXMISO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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