- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07566455
Comparing Intra-Umbilical Versus Intravenous Oxytocin in Women During the Third Stage of Labor for Reducing Blood Loss
Comparing the Effect of Intra-Umbilical Versus Intravenous Oxytocin During Third Stage of Labor on Mean Blood Loss
The goal of this clinical trial is to determine whether giving oxytocin through the umbilical cord is more effective than giving it through a vein in reducing blood loss during the third stage of labor. The third stage of labor is the period between the birth of the baby and the delivery of the placenta. Excessive bleeding after delivery, known as postpartum hemorrhage, is a major cause of maternal illness and death worldwide. Oxytocin is commonly used to help the uterus contract and reduce bleeding after childbirth.
The main question this study aims to answer is:
Does intra-umbilical oxytocin reduce the average amount of blood loss during the third stage of labor compared with intravenous oxytocin?
Researchers will conduct a randomized controlled trial involving 60 women with uncomplicated pregnancies who are in spontaneous labor. Participants will be randomly assigned to one of two groups.
Participants in the first group will receive 10 IU oxytocin intravenously at the delivery of the baby's anterior shoulder. Participants in the second group will receive 10 IU oxytocin injected into the umbilical cord after the baby is delivered.
In both groups, the placenta will be delivered using controlled cord traction. Blood loss will be measured by collecting blood in a kidney tray and by weighing pre-weighed sanitary pads for the first 24 hours after delivery.
Researchers will compare the average blood loss between the two groups to determine which method of administering oxytocin is more effective in reducing postpartum bleeding.
연구 개요
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Punjab Province
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Multan, Punjab Province, 파키스탄, 60000
- CMH Multan Institute of Medical Sciences
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Gestational age 36 - 42 weeks (on LMP)
- In spontaneous labour
Exclusion Criteria:
- Chronic hypertension
- Pre-eclampsia
- Multiple pregnancies
- Preterm or postdates pregnancy
- Previous cesarean section
- Diabetes (chronic and gestational)
- Fetal macrosomia
- History of bleeding / clotting disorder
- History of anti-coagulation heparin / warfarin therapy
- Non-reassuring cardiotocograph or poor progress of labour
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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활성 비교기: Intravenous Oxytocin
Women in this group will receive 10 IU oxytocin administered intravenously at the delivery of the anterior shoulder of the baby during the third stage of labor.
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10 IU oxytocin diluted in normal saline administered slowly via intravenous route at the time of delivery of the anterior shoulder to facilitate uterine contraction and reduce blood loss.
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실험적: Intraumbilical Oxytocin
Women in this group will receive 10 IU oxytocin administered through the umbilical vein after delivery of the baby during the third stage of labor.
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10 IU oxytocin diluted in 10 mL normal saline injected into the umbilical vein approximately 2 cm from the introitus after delivery of the baby, with the solution gently milked toward the placental insertion to promote placental separation and reduce blood loss.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Blood Loss During the Third Stage of Labor and Within the First 24 Hours After Vaginal Delivery
기간: From delivery of the baby until 24 hours postpartum
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The average amount of blood lost after delivery will be measured in milliliters.
Blood loss will be collected in a kidney tray immediately after delivery and quantified using a graduated cylinder.
Additional blood loss during the first 24 hours postpartum will be measured using pre-weighed sanitary pads (1 gram weight increase = 1 mL blood loss).
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From delivery of the baby until 24 hours postpartum
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공동 작업자 및 조사자
수사관
- 연구 의자: Nidda Y Assistant Professor, FCPS, CMH Multan Institute of Medical Sciences
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
- U1111-1339-8043
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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