STV-analyse versus visuele evaluatie van cardiotocografie bij FGR (SAVEFGR)
Variatieanalyse op korte termijn versus visuele evaluatie van cardiotocografie bij foetale groeibeperking
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Wessel Ganzevoort, MD PhD
- Telefoonnummer: 003120-5669111
- E-mail: j.w.ganzevoort@amsterdamumc.nl
Studie Contact Back-up
- Naam: Anouk Pels, MD PhD
- Telefoonnummer: 003120-5669111
- E-mail: a.pels@amsterdamumc.nl
Studie Locaties
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Amsterdam, Nederland
- Nog niet aan het werven
- Amsterdam University Medical Center
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Contact:
- M. E. Bruins
- Telefoonnummer: +3120 566 9111
- E-mail: m.e.bruins@amsterdamumc.nl
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Maastricht, Nederland
- Nog niet aan het werven
- Maastricht University Medical Center+
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Contact:
- M. E. Bruins
- Telefoonnummer: +3120 566 9111
- E-mail: m.e.bruins@amsterdamumc.nl
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Nijmegen, Nederland
- Nog niet aan het werven
- Radboud University Medical Center
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Contact:
- M. E. Bruins
- Telefoonnummer: +3120 566 9111
- E-mail: m.e.bruins@amsterdamumc.nl
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Rotterdam, Nederland
- Nog niet aan het werven
- Erasmus MC University Medical Center
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Contact:
- M. E. Bruins
- Telefoonnummer: +3120 566 9111
- E-mail: m.e.bruins@amsterdamumc.nl
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Zwolle, Nederland
- Nog niet aan het werven
- Isala
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Contact:
- M. E. Bruins
- Telefoonnummer: +3120 566 9111
- E-mail: m.e.bruins@umcg.nl
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Provincie Groningen
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Groningen, Provincie Groningen, Nederland
- Werving
- University Medical Center Groningen
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Contact:
- Mariëlle E. Bruins
- Telefoonnummer: +31 50 361 6161
- E-mail: m.e.bruins@umcg.nl
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Visual interpretation of cardiotocography
Monitoring by visual interpretation of cardiotocography |
Visual interpretation of cardiotocography |
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Experimenteel: Short term variation
Short term variation by computer software analysis |
Short term variation in computer software analysis |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of pregnancies resulting in perinatal death
Tijdsspanne: Before discharge from neonatal intensive care unit (NICU), up to 1 year
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of children with major neonatal morbidity
Tijdsspanne: Before discharge from NICU, up to 1 year
|
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
|
|
Proportion of children with neonatal morbidities
Tijdsspanne: Before discharge from NICU, up to 1 year
|
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
|
|
Proportion of children with neurodevelopmental impairment
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Wessel Ganzevoort, MD PhD, Amsterdam UMC
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Pathologische processen
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Zwangerschap Complicaties
- Dood
- Foetale ziekten
- Groeistoornissen
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Pathologische aandoeningen, tekenen en symptomen
- Foetale groeivertraging
- Perinatale dood
Andere studie-ID-nummers
- 84591
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
There is no current plan, but data will be available upon collaboration request
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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