- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03071783
Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance (SVEA)
Intra-operative Feed Back on Traction Force During Vacuum Extraction: a Randomized Control Study of Mid and Low Metal Cup Deliveries.
The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.
By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.
연구 개요
상세 설명
The most common indications for vacuum extraction are dystocia and/or fetal asphyxia. The safety of assisted vaginal delivery with vacuum extraction has been discussed since its introduction almost fifty years ago. Serious complications such as asphyxia, intracranial hemorrhage and seizures are overrepresented at vacuum extraction compared to spontaneous vaginal delivery.
Little has been done to improve the procedure since the introduction. Safety measures recommended include restricting total time and number of pulls, a full 34 week gestation, and station of the head at the spines or below. A general advice is also to avoid excessive traction force. There is no general agreement to what a safe traction force might be. With exceeding force there seems to be an increased risk for rupture of the sagittal sinus and tearing of the falx at its attachment to the tentorium. Furthermore, when the fetal head is becoming exceedingly elongated and flattened, and as the cup pops off it might cause damage to the brain and blood vessels.
During the procedure the obstetrician is under significant stress and the subjective element of the evaluation of traction force is a concern. The difficult decision of whether to continue a heavy extraction or abort the operation is made under stressful conditions and based mostly on subjective impressions.
To provide the obstetrician with more objective information, the investigators developed a new device consisting of an intelligent handle hooked to the chain of a regular metal cup.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Stockholm, 스웨덴, 14186
- Karolinska University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Medical or social reasons for vacuum extraction with a metal cup, gestational age ≥37+0 weeks, singleton, cephalic
Exclusion Criteria:
- Multiple pregnancy, breech presentation, gestational age <37+0
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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실험적: Vacuum extraction intelligent system
Measurement and intra-operative feed back of vacuum extraction data: notification signal based an algorithm calculation using traction force (peak and time force integral) and time.
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Vacuum extraction intelligent system - this is the intervention
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간섭 없음: conventional
conventional handle
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite neonatal brain damage
기간: From start of extraction through 28 days after delivery (or until discharge from the hospital)
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Composite consists of: Hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage (ICH), seizures, perinatal mortality and subgaleal hematoma as routinely diagnosed in patient chart
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From start of extraction through 28 days after delivery (or until discharge from the hospital)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Magnus Westgren, Professor, Karolinska Institutet
간행물 및 유용한 링크
일반 간행물
- MALMSTROM T. The vacuum extractor, an obstetrical instrument. I. Acta Obstet Gynecol Scand Suppl. 1957;36(suppl 3):5-50. No abstract available.
- Moolgaoker AS, Ahamed SO, Payne PR. A comparison of different methods of instrumental delivery based on electronic measurements of compression and traction. Obstet Gynecol. 1979 Sep;54(3):299-309.
- Towner DR, Ciotti MC. Operative vaginal delivery: a cause of birth injury or is it? Clin Obstet Gynecol. 2007 Sep;50(3):563-81. doi: 10.1097/GRF.0b013e31811eaa39.
- Whitby EH, Griffiths PD, Rutter S, Smith MF, Sprigg A, Ohadike P, Davies NP, Rigby AS, Paley MN. Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. Lancet. 2004 Mar 13;363(9412):846-51. doi: 10.1016/S0140-6736(04)15730-9.
- Pettersson K, Ajne J, Yousaf K, Sturm D, Westgren M, Ajne G. Traction force during vacuum extraction: a prospective observational study. BJOG. 2015 Dec;122(13):1809-16. doi: 10.1111/1471-0528.13222. Epub 2015 Jan 5.
- Romero S, Pettersson K, Yousaf K, Westgren M, Ajne G. Perinatal outcome after vacuum assisted delivery with digital feedback on traction force; a randomised controlled study. BMC Pregnancy Childbirth. 2021 Feb 26;21(1):165. doi: 10.1186/s12884-021-03604-z.
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 (실제)
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. .