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

NCT05083910 | Completed

• 1 other identifier: 20.5.2021-E.16677
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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.

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhage; oxytocin; misoprostol; carbetocin

Outcome Measures

Primary Outcomes (1)

• Hemogram status

  Postoperative hemogram status

  Postoperative 8th hour

Secondary Outcomes (1)

• Blood Transfusion

  Postoperative 24th hour

Study Arms (3)

Oxytocin Group

EXPERIMENTAL

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

Oxytocin+Intrauterine Misoprostol

EXPERIMENTAL

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

Carbetocin

EXPERIMENTAL

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

Drug: I.V Oxytocin administration

Interventions

I.V Oxytocin administration DRUG

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.

Also known as: I.v Oxytocin+intrauterine misoprostol, I.V carbetocin administration

Carbetocin; Oxytocin Group; Oxytocin+Intrauterine Misoprostol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (2)

Bezmialem Vakif University

Istanbul, Istanbulk, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32421401 BACKGROUND

• 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.

  PMID: 32120445 RESULT

• 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.

  PMID: 31010345 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gurkan Kıran, MD

  Bezmialem Vakif University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: July 1, 2021
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)