Misoprostol Versus Active Management of Labour in CS

November 11, 2022 updated by: Aljazeera Hospital

Intrauterine Misoprostol With Active Management of Labour Versus Active Management of Labour for Prevebtion of Postpartum Hemorage in Cesarean Section ,Randomized Controlled Trial

Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .

Moreover there is misotac , that also guards against postpartum hemorage .

All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .

-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 1

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
      • Giza, Egypt
        • Algazeerah

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 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • All patients included in this research were aged 18-42 years, pregnant 37 weeks till 42 weeks

    • no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

Exclusion Criteria:

  • Exclusion Criteria:

    • The following patients were excluded , GA before 37 weeks or after 42 weeks , medical disorders with pregnancy eg. DM with pregnancy, HTN with pregnancy

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Extra medication group

-Procedure : Giving misoprostol plus syntocinon during CS

this group in which prevention of uterine atony is made by intrauterine misoprostol plus the usual syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost
Drug: Misoprostol + syntocinon and using extra uterotonic drugs when needed ; methergine
medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
Other Names:
  • DrugsMisoprostol plus syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost
ACTIVE_COMPARATOR: Active management of labour group
  • Procedure: Giving syntocinon during cesarean section
  • this group in which prevention of uterine atony is made by the usual active management of labour syntocinon and using extra uterotonic drugs when needed ; methergine , carboprost
Drug: Syntocinon and using extra uterotonic drugs when needed ; methergine carboprost
medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost
Other Names:
  • drugs ( syntocinon and using extra uterotonic drugs when needed ; methergine, carboprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of participants who passed cesarean section without postpartum hemorage
Time Frame: within 2 days post CS
within 2 days post CS

Collaborators and Investigators

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

Sponsor

Aljazeera Hospital

Collaborators

Cairo University

Investigators

  • Principal Investigator: yossra Lasheen, M.D, kasraliny hospital- Aljazeerah hospital

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)

December 28, 2017

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

March 6, 2018

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (ACTUAL)

January 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Active management of labour

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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