No registrations found.
ID
Source
Brief title
Health condition
Reduced fetal movements
Sponsors and support
Intervention
Outcome measures
Primary outcome
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)
Secondary outcome
• Mild and other neonatal outcomes (hypoglycaemia, hypothermia, admittance to neonatal ward).
• Long-term child outcomes (general health, development and behaviour).
• Maternal outcomes (health related quality of life, anxiety pre- and postpartum, hypertensive disorders of pregnancy).
• Maternal serum markers (PlGF, sFLt-1, and PlGF/sFLt-1 ratio).
• Accuracy of standard placental immunohistochemistry.
Background summary
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.
Study objective
Use of CPR as indicator for delivery in reduced fetal movements reduces perinatal mortality and improves neonatal outcome and long-term outcome.
Study design
Primary outcome: perinatal/neonatal period
Secondary outcome: Longterm neonatal outcomes at 2 years of age.
Intervention
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.
Inclusion criteria
Singleton pregnancies in cephalic presentation and normal cardiotocograph presenting with RFM beyond 37 weeks gestation
Exclusion criteria
• Small for gestational age, defined as an abdominal circumference
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7557 |
| Other | METc UMCG : METc2019.488 |