- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02676505
Effect of the Length of Second Stage of Labor in Primigravidae on Maternal & Neonatal Outcomes (RCT)
연구 개요
상태
상세 설명
The study was conducted on 434 primigravidae women admitted to Kasr El Ainy teaching Maternity Hospital for labor. The study will be done in the period between October 2015 and April 2016. The study will include 434 women with the diagnosis of the first stage of labor with at least cervical dilatation 4cm.
Ethical approval obtained and an informed consent will be taken from each patient after explaining the nature and scope of the study.
Methodology in details:
Careful and detailed history taking regarding:
- Personal history
- Complaint.
- History of present pregnancy.
- Menstrual History.
- Past history.
- Careful general examination.
- Abdominal examination.
- Local vaginal examination.
- Ultrasound examination.
Management of Cases:
Group (I)(Coached group):
It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
Group (II)(Uncoached group):
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .
Patients admitted early in labor are subjected to active management of labor as follows:
Pelvic examination performed. Routine amniotomy performed and progress assessed. When dilatation is not increasing, a low dose protocol of oxytocin infusion will be started. Oxytocin diluted in the form of 5IU in 500 ml Ringer lactate making a concentration of nearly 1mu oxytocin/1ml Ringer solution. Infusion instituted at a rate of 1 -2 milliunit (15-30 drops) per minute and increased gradually in increments of 1 -2 milliunit per minute at 30 minutes interval, until at least three uterine contractions noted in a 10 minute period using cardio tocograph.
Assessment of each stage of labor was performed as follow:
First stage of labor:
It includes:
- Duration of the first stage of labor.
- Rate of cervical dilatation and foetal descent.
- Adequacy of uterine contractions and documentation of labor dystocia.
- Excess uterine activity consisted of uterine tachysystole, hypertonus or uterine hyperstimulation
Second stage of labor:
It includes:
- Duration of the second stage.
- Rate of the descent of foetus.
- Monitoring of foetal heart rate every 5 minutes by sonicaid or continuous by CTG.
- Use of mediolateral episiotomy.
- Intervention will be considered either by instrumental delivery,fundal pressure or by CS If the second stage is prolonged more than 2 hours.
- Monitoring of maternal oxygen saturation by pulse oximeter.
Third stage of labor:
- Duration of the third stage.
- Assessment of any vaginal laceration or perineal tears with their repair as well as repair of episiotomy.
- Assessment of quantity of blood loss and assessment of uterine atony(vital instability,number of soaked pads and hemoglobin drop) .
- Rate of caesarean section during varying stages of labor.
- Neonatal assessment:
It includes:
- Foetal sex and body weight.
- APGAR score at 1 and 5 minutes..
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
All patients admitted in the first stage of labor with cervical dilatation of 4 cm at least:
- Women age 18-35 years.
- 37-41 weeks gestation pregnancy.
- Singleton pregnancy and vertex presentation.
- Women have no chronic or pregnancy-induced illnesses.
- Women are in established, spontaneous labor.
Exclusion Criteria:
- Malpresentation.
- Women with previous uterine scar.
- Multiple pregnancy
- Ante partum hemorrhage.
- Cephalopelvic disproportion.
- Women have chronic illnesses.
- Women with abnormal antenatal period.
- Patients with foetal distress
- Premature rupture of membrane
- Woman having any contraindication to vaginal delivery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
1
Group (I)(Coached group): It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds. |
It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward.
They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth.
The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
|
|
2
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth.
|
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Duration of the second stage
기간: 0-3 hours
|
0-3 hours
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Severe maternal morbidity e.g post partum hemorrhage
기간: intrapartum and 2 hours postpartum.
|
intrapartum and 2 hours postpartum.
|
|
APGAR score after one and five minutes.
기간: 1-5 minutes
|
1-5 minutes
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Kasr El Ainy, hospital, kasr el ainy street,cairo,egypt
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KasrELAini maternity hospital
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. .
Coached pushing group에 대한 임상 시험
-
Samsung Medical Center모병
-
Aarhus University HospitalUniversity of Aarhus완전한
-
University of Illinois at ChicagoNational Institute of Mental Health (NIMH); Washington University School of Medicine; Stanford... 그리고 다른 협력자들완전한
-
Queen Mary University of LondonUniversity of Belgrade아직 모집하지 않음