- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05083910
Randomization of Oxytocin, Oxytocin+Intrauterine Misoprostol and Carbetocin During C-section
Randomized Controlled Comparison of Blood Loss in Patients Who Received Oxytocin Infusion, Oxytocin Infusion, and Intrauterine Misoprostol and Carbetocin During Cesarean Delivery
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul, 칠면조
- Bezmialem Vakif University
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Istanbulk
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Istanbul, Istanbulk, 칠면조
- Bezmialem Vakif University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 카베토신
카베토신 100mg을 출산 직후 정맥주사
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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.
다른 이름들:
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실험적: 옥시토신 그룹
20IU를 0.9% 염화나트륨 500mL에 용해하여 125mL/h의 속도로 주입한 옥시토신 주입액을 제대를 조인 직후에 투여하였다.
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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.
다른 이름들:
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실험적: 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
|
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemogram status
기간: Postoperative 8th hour
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Postoperative hemogram status
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Postoperative 8th hour
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Transfusion
기간: Postoperative 24th hour
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Number of patients needing Blood Transfusion
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Postoperative 24th hour
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공동 작업자 및 조사자
수사관
- 연구 의자: Gurkan Kıran, MD, Bezmialem Vakif University
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20.5.2021-E.16677
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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