The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.
The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.
연구 개요
상세 설명
The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.
The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.
The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Haifa, 이스라엘
- Rambam Health Care Campus
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
1. Singleton deliveries at or beyond 37 weeks' gestation.
Exclusion Criteria:
- Non-vertex presentation.
- Trial of labor after CS.
- High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
- Known fetal anomalies and intrauterine fetal demise.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
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To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The rate of primary CS.
기간: Between 2011 and 2017.
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The rate of primary CS in percentage of the total participants.
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Between 2011 and 2017.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The rate of operative vaginal delivery.
기간: Between 2011 and 2017.
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The rate of operative vaginal delivery in percentage of the total participants.
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Between 2011 and 2017.
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Post-partum hemorrhage.
기간: Between 2011 and 2017.
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Post-partum hemorrhage as estimated in liters.
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Between 2011 and 2017.
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The need for blood transfusion.
기간: Between 2011 and 2017.
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Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage.
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Between 2011 and 2017.
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Third-and fourth-degree laceration rate.
기간: Between 2011 and 2017.
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Third-and fourth-degree laceration rate of the total number of participants.
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Between 2011 and 2017.
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Chorioamnionitis rate.
기간: Between 2011 and 2017.
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Chorioamnionitis rate in percentage of the total participants.
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Between 2011 and 2017.
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Admission to the NICU.
기간: Between 2011 and 2017.
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Admission to the NICU in percentage of the total participants.
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Between 2011 and 2017.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kamel Mattar, MD, Principal Investigator
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
기타 연구 ID 번호
- 0258-17-RMB
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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