Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy: A Randomized Controlled Trial
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Induction of labour is commonly performed when continuation of pregnancy is considered less beneficial than delivery. This randomized controlled trial will compare the effectiveness and safety of two approaches to cervical ripening and induction of labour in women with term pregnancy.
Eligible participants will have a gestational age of 37-42 weeks and will be admitted to the hospital for induction of labour without significant comorbidities. Gestational age will be confirmed using a dating scan or last menstrual period, and baseline fetal monitoring will be performed using cardiotocography (CTG) before induction.
Participants will be randomly allocated to one of two treatment groups.
In the concurrent group, a PGE2 vaginal pessary and a Foley catheter will be inserted concurrently. The Foley catheter balloon will be inflated with 30 mL of normal saline.
In the sequential group, the Foley catheter will be inserted first, followed by insertion of the PGE2 vaginal pessary 12 hours later.
The study will primarily assess the rate of vaginal delivery within 24 hours of initiation of induction. The study will also assess the overall effectiveness and safety of the two induction approaches, including the induction-to-delivery interval and relevant maternal and fetal complications.
Potential complications associated with induction of labour include failure of induction, uterine hyperstimulation, fetal distress or abnormal CTG, meconium-stained liquor, postpartum haemorrhage, uterine rupture, and chorioamnionitis. Participants will be continuously monitored during the induction process so that appropriate clinical management can be provided if complications occur.
The findings of this study may contribute to the development of safe, effective, and patient-centred induction-of-labour protocols, particularly in resource-constrained healthcare settings.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Shahzadi Saima Hussain, MHR
- 전화번호: +923337111981
- 이메일: saima.hussain@lrh.edu.pk
연구 연락처 백업
- 이름: Dr Jawad Khan, PhD
- 전화번호: +92 334 9011681
- 이메일: mdrjawad@yahoo.com
연구 장소
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KPK
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Peshawar, KPK, 파키스탄, 25000
- Lady Reading Hospital
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연락하다:
- Dr Jawad Khan, PhD
- 전화번호: +92 334 9011681
- 이메일: mdrjawad@yahoo.com
-
연락하다:
- Shezadi Saima Hussain, MHR
- 전화번호: +92 333 7111981
- 이메일: saima.hussain@lrh.edu.pk
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Exclusion Criteria:
- Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Concurrent Induction of Labour
Participants will receive concurrent cervical ripening with a PGE2 vaginal pessary and insertion of a Foley catheter.
The Foley catheter balloon will be inflated with 30 mL of normal saline.
Both interventions will be initiated concurrently at the start of induction of labour.
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A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
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활성 비교기: Sequential Induction of Labour
Participants will receive sequential cervical ripening with a Foley catheter followed by insertion of a PGE2 vaginal pessary 12 hours later.
The Foley catheter will be inserted first, followed by the PGE2 vaginal pessary after 12 hours.
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A Foley catheter will be used for mechanical cervical ripening.
The balloon will be inflated with 30 mL of normal saline.
A PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time from initiation of induction of labour to vaginal delivery
기간: From initiation of induction of labour until vaginal delivery, up to 24 hours
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Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
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From initiation of induction of labour until vaginal delivery, up to 24 hours
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Successful vaginal delivery
기간: From initiation of induction of labour until delivery, up to 24 hours
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Proportion of participants who achieve vaginal delivery following induction of labour.
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From initiation of induction of labour until delivery, up to 24 hours
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Shahzadi Saima Hussain, MHR, Khyber Medical University Peshawar, Pakistan
- 연구 책임자: Dr Jawad Khan, PhD, Khyber Medical University Peshawar, Pakistan
- 수석 연구원: Dr Mehnaz Faisal, MHPE, FCPS, Lady Reading Hospital Peshawar
간행물 및 유용한 링크
일반 간행물
- Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.
- Eser A, Ozkaya E, Abide CY, Eser T, Eser GY, Abike F, Tayyar AT, Eroglu M. Transcervical Foley balloon catheter and vaginal prostaglandin E2 insert combination vs. vaginal prostaglandin E2 insert only for induction of labor at term: a randomized clinical trial. Arch Gynecol Obstet. 2019 Feb;299(2):451-457. doi: 10.1007/s00404-018-4998-8. Epub 2018 Dec 7.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
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이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- KMU/DIR/CTU/2026/12
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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