Foley Labor Induction Trial at Term and in PROM
A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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New York
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Elmhurst, New York, 미국, 11373
- Elmhurst Hospital Center
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
Exclusion Criteria:
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control
No oxytocin while the Foley bulb is in place
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실험적: Oxytocin
Use of oxytocin while the Foley bulb is in place
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Use of oxytocin while the Foley bulb is in place
다른 이름들:
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실험적: PROMS Foley and oxytocin
Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.
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Use of oxytocin while the Foley bulb is in place
다른 이름들:
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간섭 없음: PROMS no Foley bulb
Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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induction time to delivery
기간: Time from induction to delivery, average 12-28 hours
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The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
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Time from induction to delivery, average 12-28 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mode of delivery
기간: average of 12-28 hours from induction until official time of birth
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The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery.
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average of 12-28 hours from induction until official time of birth
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estimated blood loss
기간: average of 12-28 hours from induction until official time of birth
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average of 12-28 hours from induction until official time of birth
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uterine atony
기간: average of 12-28 hours from induction until official time of birth
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uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.
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average of 12-28 hours from induction until official time of birth
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chorioamnionitis
기간: average of 12-28 hours from induction until official time of birth
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Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor.
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average of 12-28 hours from induction until official time of birth
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neonatal birthweight
기간: average of 12-28 hours from induction until official time of birth
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average of 12-28 hours from induction until official time of birth
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공동 작업자 및 조사자
수사관
- 수석 연구원: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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