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

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
I.V Oxytocin administration
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring postpartum hemorrhage, oxytocin, misoprostol, carbetocin

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif University
  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Oxytocin Group

Oxytocin+Intrauterine Misoprostol

Carbetocin

Arm Description

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

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

100-mg carbetocin was intravenously administered immediately after birth of the baby

Outcomes

Primary Outcome Measures

Hemogram status
Postoperative hemogram status

Secondary Outcome Measures

Blood Transfusion
Number of patients needing Blood Transfusion

Full Information

First Posted
October 6, 2021
Last Updated
January 23, 2022
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05083910
Brief Title
Randomization of Oxytocin, Oxytocin+Intrauterine Misoprostol and Carbetocin During C-section
Official Title
Randomized Controlled Comparison of Blood Loss in Patients Who Received Oxytocin Infusion, Oxytocin Infusion, and Intrauterine Misoprostol and Carbetocin During Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 22, 2022 (Actual)
Study Completion Date
January 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
postpartum hemorrhage, oxytocin, misoprostol, carbetocin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin Group
Arm Type
Experimental
Arm Description
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
Arm Title
Oxytocin+Intrauterine Misoprostol
Arm Type
Experimental
Arm Description
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
Arm Title
Carbetocin
Arm Type
Experimental
Arm Description
100-mg carbetocin was intravenously administered immediately after birth of the baby
Intervention Type
Drug
Intervention Name(s)
I.V Oxytocin administration
Other Intervention Name(s)
I.v Oxytocin+intrauterine misoprostol, I.V carbetocin administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemogram status
Description
Postoperative hemogram status
Time Frame
Postoperative 8th hour
Secondary Outcome Measure Information:
Title
Blood Transfusion
Description
Number of patients needing Blood Transfusion
Time Frame
Postoperative 24th hour

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurkan Kıran, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Chair
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
State/Province
Istanbulk
Country
Turkey
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32421401
Citation
Ibrahim ZM, Sayed Ahmed WA, Abd El-Hamid EM, Taha OT, Elbahie AM. Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section. Hypertens Pregnancy. 2020 Aug;39(3):319-325. doi: 10.1080/10641955.2020.1768268. Epub 2020 May 18.
Results Reference
background
PubMed Identifier
32120445
Citation
Takmaz T, Ozcan P, Sevket O, Karasu AFG, Islek SH, Halici BNA. Less Blood Loss by Earlier Oxytocin Infusion in Cesarean Sections? A Randomized Controlled Trial. Z Geburtshilfe Neonatol. 2020 Oct;224(5):275-280. doi: 10.1055/a-1108-2017. Epub 2020 Mar 2.
Results Reference
result
PubMed Identifier
31010345
Citation
Bahadur A, Khoiwal K, Bhattacharya N, Chaturvedi J, Kumari R. The effect of intrauterine misoprostol on blood loss during caesarean section. J Obstet Gynaecol. 2019 Aug;39(6):753-756. doi: 10.1080/01443615.2019.1581743. Epub 2019 Apr 22.
Results Reference
result

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

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