Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section

August 15, 2024 updated by: RAMY AHMED, Ain Shams University
Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - Medical disorders ie: Hypertensive diseases with pregnancy - Diabetes Mellitus - Collagen diseases - Coagulopathies - Cardiac diseases - Anemia
  • History of postpartum hemorrhage
  • Placental disorders ie: placenta previa
  • Infertility and ICSI
  • High Parity
  • History of Endometriosis
  • Fetal disorders (IUGR, IUFD, Preterm, Congenital anomalies, oligohydramnios or polyhydramnios, macrosomia)
  • Preterm labor on uterine relaxants
  • Twins pregnancy
  • Patients on antiplatelets and anticoagulants
  • Uneventful antenatal care

Exclusion Criteria:

  • - Oxytocin Allergy
  • Normal uncomplicated pregnancy
  • Emergency cesarean section
  • Exhausted uterus due to trial of normal labor
  • Couvelaire uterus

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: Group A (standard oxytocin dose)
Drug: Oxytocin
will receive 10 IU oxytocin intravenous bolus over one min and infusion of 10 IU oxytocin in 500 ml of 0.9 saline over four hours.
Active Comparator: Group B (high dose oxytocin)
Drug: Oxytocin
will receive 10 IU oxytocin intravenous bolus over one min and infusion of 10 IU oxytocin in 500 ml of 0.9 saline over four hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: at the end of the operation
measure blood in suction, towels and pads
at the end of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
haemoglobin
Time Frame: immediate preoperative
by laboratory asessment
immediate preoperative
haemoglobin
Time Frame: 6 hours postoperative
by laboratory asessment
6 hours postoperative

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 (Estimated)

August 25, 2024

Primary Completion (Estimated)

April 25, 2025

Study Completion (Estimated)

April 25, 2025

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laura 1 protocol

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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