Use of CPR as indicator for delivery in reduced fetal movements reduces perinatal mortality and improves neonatal outcome and long-term outcome.
ID
Bron
Verkorte titel
Aandoening
Reduced fetal movements
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Composite perinatal outcome: stillbirth and neonatal mortality (< 28 days), NICU admittance longer than 12 hours, APGAR score < 7 at 5 min, pH < 7.10 umbilical artery, emergency delivery for fetal distress, severe neonatal morbidity (respiratory distress syndrome (RDS), hypoxic ischemic encephalopathy (HIE), sepsis, necrotizing enterocolitis (NEC), supplementary oxygen therapy (> 7 days)
Achtergrond van het onderzoek
Maternal perception of reduced fetal movements (RFM) occurs in 6-15% of pregnancies. A perceived reduction of fetal movements can result from harmless causes, such as altered fetal position or maternal distraction due to other activities or stress. In some cases however, RFM is an important sign of placental insufficiency. The major challenge for RFM lies in its high incidence and the low absolute chance that the fetus is severely compromised. The fear of these vital consequences leads to substantial overtreatment of patients who experience RFM.
Functional parameters, such as Doppler ultrasound and serum biomarkers can help distinguish the compromised fetuses from healthy fetuses. Redistribution of the fetal circulation, signaled by a low Cerebro Placental Ratio (CPR) reflects redistribution of the fetal circulation and is a compensatory adaptation to nutrient and oxygen deprivation caused by placental insufficiency. An abnormal CPR may identify compromised fetuses, also within normal weight ranges.
With this study we aim to assess if prompt start of delivery (<16 hours) in term pregnancies complicated by reduced fetal movements and an abnormal CPR (<1.1) improves neonatal outcome (including perinatal mortality and long-term (neurodevelopmental) outcome) and maternal outcome. We aim to reduce the over treatment of healthy fetuses with RFM and the under treatment of the fetuses at risk and, to investigate if a normal CPR predicts favorable neonatal outcome.
Doel van het onderzoek
Use of CPR as indicator for delivery in reduced fetal movements reduces perinatal mortality and improves neonatal outcome and long-term outcome.
Onderzoeksopzet
Primary outcome: perinatal/neonatal period
Secondary outcome: Longterm neonatal outcomes at 2 years of age.
Onderzoeksproduct en/of interventie
Expedited delivery is pursued in women with an abnormal CPR (<1.1) in the open study arm. In this case we aim to start delivery within 16 hours or an elective caesarean section will be advanced. Women in the concealed arm will not have their CPR results revealed and will receive routine clinical care.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Singleton pregnancies in cephalic presentation and normal cardiotocograph presenting with RFM beyond 37 weeks gestation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Small for gestational age, defined as an abdominal circumference
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
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NTR-new | NL7557 |
Ander register | METc UMCG : METc2019.488 |