Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery .

March 17, 2025 updated by: Ahmed M Maged, MD, Cairo University

Comparative Study Between Oxytocin Infusion Before and After Placental Delivery on Blood Loss During and After Cesarean Delivery in Low Risk Women.

Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were randomized using computer-generated random numbers into 2 groups. Group I included 32 women who received oxytocin infusion before placental delivery just after cord clamping and group II included 32 women who received oxytocin infusion after placental delivery. In both groups 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

Study Type

Interventional

Enrollment (Actual)

64

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
      • Cairo, Egypt, 12111
        • Armed force 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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 - 40 years
  • singleton full term pregnancy.
  • Candidate for elective cesarean delivery under spinal anaesthesia

Exclusion Criteria:

  • women at high risk for intraoperative bleeding as those with placenta previa or other placental abnormalities
  • women with bleeding or coagulation disorders.
  • Medical disorder associating pregnancy as preeclampsia or diabetes
  • Allergy or contraindications to oxytocin
  • Fetal macrosomia, or congenital anomalies
  • Polyhydramnios
  • Uterine abnormalities as fibroids
  • Women with intraoperative complications as vascular or visceral injuries

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oxytocin before placental delivery
oxytocin infusion before placental delivery just after cord clamping 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
Drug: Oxytocin
10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
Active Comparator: oxytocin after placental delivery
oxytocin infusion after placental delivery 10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.
Drug: Oxytocin
10 IU of oxytocin (Syntocinon, Novartis, Basel, Switzerland) were diluted in 500 mL of normal saline and administered through intravenous infusion over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: during cesarean delivery
This was measured by weighing the surgical sponges and the suction canisters used during the procedure
during cesarean delivery

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ahmed Maged, MD, 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 (Actual)

August 30, 2023

Primary Completion (Actual)

May 27, 2024

Study Completion (Actual)

September 14, 2024

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110

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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