Randomization of Oxytocin, Oxytocin+Intrauterine Misoprostol and Carbetocin During C-section

January 23, 2022 updated by: Bezmialem Vakif University

Randomized Controlled Comparison of Blood Loss in Patients Who Received Oxytocin Infusion, Oxytocin Infusion, and Intrauterine Misoprostol and Carbetocin During Cesarean Delivery

Postpartum haemorrhage (PPH) remains an important cause of maternal morbidity and mortality and it accounts for approximately 25% of all deaths worldwide. Drugs such as oxytocin, carbetocin, misoprostol, prostaglandin F2a and methylergonovine have been tested for bleeding control during and after cesarean section. Oxytocin is the most widely used agent for the prevention of postpartum hemorrhage.The primary aim of this study is to reduce the mean blood loss during cesarean section.In this study, the investigators planned to compare peroperative and postoperative blood loss levels by giving oxytocin alone to the 1st group, oxytocin and intrauterine misoprostol to the 2nd group, and carbetocin to the 3rd group of patients who were randomly divided into 3 groups.In this study, we aimed to compare the efficacy of oxytocin, misoprostol and carbetocin in preventing uterine blood loss during cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our prospective, randomized controlled study was conducted at the Department of Obstetrics and Gynecology of Bezmialem University Hospital between July and November 2021. The study protocol was approved by the Ethical Committee of the Medical Faculty of Bezmialem University. Written informed consent was obtained from all patients. We included a total of 156 women between 18 and 40 years of age who underwent a primary cesarean section or old 1 cesarean section under spinal anesthesia at term single pregnancy with an American Society of Anesthesiology physical status of I or II. This trial was designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

The patients included in this study were randomly divided into three groups by random allocation using a computer-generated random number. Group I: Oxytocin(Synpitan forte®; Deva Pharma, Istanbul, Turkey) (n = 52 )( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord). Group II: (n =52) oxytocin plus intrauterine misoprostol (Synpitan forte®; Deva Pharma, Istanbul, Turkey) (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III: (n =52) 100-mg carbetocin (Synpitan forte®; Deva Pharma, Istanbul, Turkey) was intravenously administered immediately after birth of the baby. All surgeries were performed by the same team of two surgeons.. The collected data were age, prepregnancy body mass index (BMI), gravida, parity, indication of cesarean section, gestational age at birth, Apgar scores at 1 and 5 min, birth weight, neonatal intensive care unit (NICU) admission, the preoperative hemoglobin and hematocrit concentrations, the change in the hemoglobin and hematocrit concentrations (difference between preoperative and postoperative levels), operating time, intraoperative blood loss.

In this study, the investigators aimed to compare the efficacy of oxytocin, misoprostol and carbetocin in preventing uterine blood loss during cesarean section.

Study Type

Interventional

Enrollment (Actual)

156

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

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University
    • Istanbulk
      • Istanbul, Istanbulk, Turkey
        • Bezmialem Vakif 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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Single pregnancy greater than 37 weeks
  • Pregnant women between the ages of 18-40 Volunteer

Exclusion Criteria:

  • Clinical diagnosis of Gestational diabetes
  • Clinical diagnosis of Gestational hypertension
  • Clinical diagnosis of preeclampsia
  • Clinical diagnosis of Placenta previa,
  • Clinical diagnosis of abruptio placenta
  • Conditions that cause excessive distention of the uterus (multiple pregnancies, severe polyhydramnios, fetal macrosomia, large fibroids displacing the cavity) Thrombophilia disorders, anticoagulation therapy History of major abdominal surgery

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
Experimental: Carbetocin
100-mg carbetocin was intravenously administered immediately after birth of the baby
Drug: I.V Oxytocin administration
Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord). Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
Other Names:
  • I.v Oxytocin+intrauterine misoprostol
  • I.V carbetocin administration
Experimental: Oxytocin Group
The oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord
Drug: I.V Oxytocin administration
Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord). Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
Other Names:
  • I.v Oxytocin+intrauterine misoprostol
  • I.V carbetocin administration
Experimental: Oxytocin+Intrauterine Misoprostol
The oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity
Drug: I.V Oxytocin administration
Group I: Oxytocin( the oxytocin infusion consisting of 20 IU dissolved in 500 mL of normal 0.9 % sodium chloride solution and infused at a rate of 125 mL/h was administered immediately after clamping the umbilical cord). Group II:oxytocin plus intrauterine misoprostol (the oxytocin infusion was administered immediately after clamping the umbilical cord and misoprostol tablet (400 mg) was placed into uterine cavity at the fundus after delivery of the placenta and swabbing the cavity. Group III:100-mg carbetocin was intravenously administered immediately after birth of the baby.
Other Names:
  • I.v Oxytocin+intrauterine misoprostol
  • I.V carbetocin administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemogram status
Time Frame: Postoperative 8th hour
Postoperative hemogram status
Postoperative 8th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Transfusion
Time Frame: Postoperative 24th hour
Number of patients needing Blood Transfusion
Postoperative 24th hour

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: Gurkan Kıran, MD, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2021

Primary Completion (Actual)

January 22, 2022

Study Completion (Actual)

January 22, 2022

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 23, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.5.2021-E.16677

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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