Control of Blood Loss During Caesarean Section

October 4, 2014 updated by: Waleed El-khayat, Cairo University

A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section

trial of 3 protocols to determine the best one to control blood loss during caesarean section

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study population will be divided into 3 groups each containing 200 women:

Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby.

Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.

Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity.

Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

  1. After admission of each case in the pre-operative period.
  2. Immediately post- operative.
  3. 24 hours post- operative.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • 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, 12211
        • faculty of medicine , Cairo University

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

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients booked for elective cesarean section.
  • Singleton pregnancies.
  • Primigravida or multipara ,first cesarean section or previous .

Exclusion Criteria:

  • Patients with obstetric hemorrhage.
  • Uterine laceration.
  • Placenta previa.
  • Blood dyscrasias.
  • Large fibroids.
  • Multiple pregnancy.
  • Pre-eclampsia.
  • Marked maternal anemia.
  • Previous history of PPH.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oxytocin bolus

5 IU bolus iv over 3 minutes after delivery of the baby Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward.

Hemoglobin level and haematocrit value will be done as follow:-

  1. After admission of each case in the pre-operative period.
  2. Immediately post- operative.
  3. 24 hours post- operative.
Drug: oxytocin
group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
Other Names:
  • syntocinon
Active Comparator: oxytocin bolus & oxytocin infusion
5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby
Drug: oxytocin
group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
Other Names:
  • syntocinon
Active Comparator: misoprostol intrauterine
misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity
Drug: Misoprostol
misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of blood loss
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Haemoglobin % and haematocrit value
Time Frame: 12 month
12 month

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Waleed M El-khayat, M.D., Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo 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

September 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 4, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 582011

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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