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

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: I.V Oxytocin administration

• Registration Number: NCT05083910
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-19
• Status Verified: 2022-01
• Primary Completion: 2022-01-22
• Study Completion: 2022-01-22
• Last Update Submitted: 2022-01-23
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin Group	I.V Oxytocin administration	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
Oxytocin+Intrauterine Misoprostol	I.V Oxytocin administration	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
Carbetocin	I.V Oxytocin administration	100-mg carbetocin was intravenously administered immediately after birth of the baby

Primary Outcome Measures

Name	Time	Method
Hemogram status	Postoperative 8th hour	Postoperative hemogram status

Secondary Outcome Measures

Name	Time	Method
Blood Transfusion	Postoperative 24th hour	Number of patients needing Blood Transfusion

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey