FGR에서 심전도 검사의 STV 분석과 시각적 평가 비교 (SAVEFGR)
태아 성장 제한에서 심전도 검사의 단기 변화 분석과 시각적 평가 비교
This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.
연구 개요
상세 설명
Severe, early-onset fetal growth restriction (FGR, <32 weeks gestation) is a condition in which the fetus does not reach its growth potential due to placental insufficiency[. This condition affects about 0.3% of pregnancies, accounting for an estimated 15,000 babies in Europe being born premature below 32 weeks gestation. The main clinical dilemma of FGR lies in the timing of birth, given the balance of risks of antenatal mortality and severe damage to organs and the aggravated neonatal effects of prematurity: death or survival with severe neurodevelopmental impairment. The mainstay of clinical management in these cases pivots around the anticipation of the risk of fetal demise from placental oxygenation failure. The monitoring variables that are currently available comprise assessment of the severity of metabolic insufficiency (fetal size and growth, Doppler ultrasound, serum biomarkers) and the early detection of progressive fetal hypoxia with cardiotocography (CTG). The common approach is to deliver the fetus when signs of advanced hypoxia appear on CTG. A delicate balance exists between having the fetus born (too) early and facing the risks of extreme prematurity combined with a very low birthweight; and between delivering the fetus (too) late when the fetus has the disadvantage of hypoxia at birth. The decision when to deliver the fetus, is made mostly based on the CTG. The inter- and intra-observer variability could be overcome by software analysis according to the original Dawes&Redman algorithm. The software calculates the short-term variation (STV) of the inter-beat interval expressed in milliseconds, and a range of secondary calculations. In contrast with repeated decelerations, when fetal hypoxia is considered evident, the place of the software analysis of the fetal heart rate variability is less clear. Although the advantages of mathematized and uniform quantification of the fetal heart rate variability appear self-evident, there are no studies with sufficient power to detect an association of intervention based on STV at any threshold with the most important outcomes: fetal death and long-term infant outcome.
The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in computerized CTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe, early-onset FGR.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wessel Ganzevoort, MD PhD
- 전화번호: 003120-5669111
- 이메일: j.w.ganzevoort@amsterdamumc.nl
연구 연락처 백업
- 이름: Anouk Pels, MD PhD
- 전화번호: 003120-5669111
- 이메일: a.pels@amsterdamumc.nl
연구 장소
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Amsterdam, 네덜란드
- 아직 모집하지 않음
- Amsterdam University Medical Center
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연락하다:
- M. E. Bruins
- 전화번호: +3120 566 9111
- 이메일: m.e.bruins@amsterdamumc.nl
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Maastricht, 네덜란드
- 아직 모집하지 않음
- Maastricht University Medical Center+
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연락하다:
- M. E. Bruins
- 전화번호: +3120 566 9111
- 이메일: m.e.bruins@amsterdamumc.nl
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Nijmegen, 네덜란드
- 아직 모집하지 않음
- Radboud University Medical Center
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연락하다:
- M. E. Bruins
- 전화번호: +3120 566 9111
- 이메일: m.e.bruins@amsterdamumc.nl
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Rotterdam, 네덜란드
- 아직 모집하지 않음
- Erasmus MC University Medical Center
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연락하다:
- M. E. Bruins
- 전화번호: +3120 566 9111
- 이메일: m.e.bruins@amsterdamumc.nl
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Zwolle, 네덜란드
- 아직 모집하지 않음
- Isala
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연락하다:
- M. E. Bruins
- 전화번호: +3120 566 9111
- 이메일: m.e.bruins@umcg.nl
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Provincie Groningen
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Groningen, Provincie Groningen, 네덜란드
- 모병
- University Medical Center Groningen
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연락하다:
- Mariëlle E. Bruins
- 전화번호: +31 50 361 6161
- 이메일: m.e.bruins@umcg.nl
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.
- Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95.
- Maternal age ≥ 18 years.
- Able to provide written informed consent for collection and use of data on informed consent form in available language.
Exclusion Criteria:
- Known congenital or chromosomal anomalies influencing perinatal outcome.
- Imminent labour or expected maternal indication for delivery < 48 hours.
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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활성 비교기: Visual interpretation of cardiotocography
Monitoring by visual interpretation of cardiotocography |
Visual interpretation of cardiotocography |
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실험적: Short term variation
Short term variation by computer software analysis |
Short term variation in computer software analysis |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of pregnancies resulting in perinatal death
기간: Before discharge from neonatal intensive care unit (NICU), up to 1 year
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Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU |
Before discharge from neonatal intensive care unit (NICU), up to 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of children with major neonatal morbidity
기간: Before discharge from NICU, up to 1 year
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Major neonatal morbidity is a composite outcome defined as intraventricular hemorrhage grade 3 or more, periventricular leukomalacia grade 2 or more, moderate or severe bronchopulmonary dysplasia, necrotizing enterocolitis Bell stage 2 or more, or retinopathy of prematurity requiring therapy. |
Before discharge from NICU, up to 1 year
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Proportion of children with neonatal morbidities
기간: Before discharge from NICU, up to 1 year
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Individual neonatal morbidities of the abovementioned composite outcome and additionally persisting ductus arteriosus, persistent pulmonary hypertension of the newborn (PPHN), respiratory distress syndrome (RDS), period of invasive mechanical ventilation in days, medication need, hypoglycaemia, neonatal jaundice, sepsis and cardiovascular function. |
Before discharge from NICU, up to 1 year
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Proportion of children with neurodevelopmental impairment
기간: At two years of corrected age
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Neurodevelopmental impairment is defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score < 85, composite motor score < 85), cerebral palsy, with a Gross Motor Function Classification System (GMFCS) grade > 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age |
At two years of corrected age
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wessel Ganzevoort, MD PhD, Amsterdam UMC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 84591
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
There is no current plan, but data will be available upon collaboration request
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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