Fetal growth restriction Pregnancy and Childbirth Fetal growth restriction
Conditions
Interventions
Current interventions as of 27/07/2020:
Women will be randomised to delivery or conservative management (cCTG monitoring and traditional ultrasound). The randomisation process will be completed throug
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/07/2020: All criteria should be fulfilled to be eligible for randomisation: 1. Women = 18 years old 2. Pregnant with singleton non-anomalous fetuses 3. Between 32+0 and 36+6 weeks of gestation 4. Estimated fetal weight or abdominal circumference 1.0 (32+0-33+6 weeks) or >0.8 (34+0-36+6 weeks) measured at least twice in any 24 hours period 6. Normal STV on cCTG (4.5 msec or above) Previous inclusion criteria: For screening: 1. Women = 18 years old 2. Pregnant with singleton fetuses at risk of compromise: 2.1 Between 32+0 and 36+6 weeks of gestation and 2.2 Estimated fetal weight or abdominal circumference 1.5 (32-33+6 weeks) / >1.0 (34-36+6 weeks) and: 3.2 Normal STV on cCTG (> 4.5msec) and: 3.3 No contraindications to either trial treatment arm
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/07/2020: 1. Indication for immediate delivery required within 48 hours 2. Unable to give informed consent 3. Preterm prelabour rupture of the membranes (PPROM) 4. Suspected placental abruption or antepartum haemorrhage 5. Presence of reversed end diastolic flow in the Umbilical Artery Previous exclusion criteria: 1. Indication for immediate delivery within 48 hours 2. Unable to give informed consent 3. Preterm prelabour rupture of the membranes (PPROM) 4. Suspected placental abruption or antepartum haemorrhage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/07/2020: Composite poor condition at birth and neonatal adverse outcome. Any of the following: 1. Poor condition at birth 1.1. Apgar score at 5 minutes <7, arterial pH of <7.0 or venous pH of <7.1 1.2. Resuscitation with intubation, chest compressions or medication 2. Fetal death/death before neonatal hospital discharge 3. Neonatal brain injury syndromes 3.1. Infants with a diagnosis consistent with hypoxic ischaemic encephalopathy: term and near-term infants only 3.2. Infants with a diagnosis of intracranial haemorrhage, perinatal stroke, hypoxic ischaemic encephalopathy (HIE), central nervous system infection, and kernicterus (bilirubin encephalopathy): all infants 3.3.Preterm white matter disease (periventricular leukomalacia): preterm infants only 3.4. Infants with a recorded seizure confirmed by EEG 4. Respiratory support 4.1. Need for mechanical support of respiration after admission to NNU, for more than 1 hour – includes need for continuous positive airways pressure (CPAP or NIPPV) or mechanical ventilation via and endotracheal tube – but excludes need for supplemental oxygen 5. Cardiovascular abnormality 5.1. Hypotensive treatment, ductus arteriosus treatment, or disseminated coagulopathy 6. Sepsis (clinical sepsis with positive blood culture, or necrotising enterocolitis requiring surgery) 7. Retinopathy of prematurity requiring treatment (laser or anti-VEGF injections) Previous primary outcome measure: Success of delivery measured using: 1. Intrauterine fetal death or neonatal death before hospital discharge 2. Gestational age at delivery 3. Birthweight 4. Birth condition (Apgar score, cord pH) 5. Admission to neonatal unit 6. Neonatal brain injury syndromes 7. Respiratory support 8. Number of neonatal unit admission days 9. Level of neonatal care 10. Morbidity including duration of respiratory support, chronic lung disease, severe intraventricular haemorrhage grade III/IV, necrotising enterocolitis requiring surg | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/07/2020: For the baby: 1. Health and developmental outcomes assessed using PARCA-R questionnaire at 2 years and the general health questionnaire up to 2 years corrected age. The PARCA-R will be completed at 24 months from correct age. It allows the following scales to be derived: Non-verbal cognitive scale and language development scale. Raw scores from the scales are standardised (by corrected age and gender) to a notional population mean of 100 SD=15 and the average of these two component scores will be taken as the overall composite score. Corrected age is where preterm babies (born before 37 weeks) use estimate date of delivery as opposed of date of birth. 2. The general health questionnaire (REF) will be used to derive the following health outcomes at 6, 12, 18 and 24 months postpartum: 2.1. Use of ANY hospital service (yes/no) and total number of contacts over the 2 year period 2.2. Admitted to hospital (yes/no) and total number of admissions over the 2 year period 2.3. Planned/unplanned admissions to hospital (yes/no) over the 2 year period 2.4. Intensive care or not over the 2 year period 2.5. Attended A&E (and not subsequently admitted) (yes/no) over the 2 year period 2.6. Attended Outpatients/clinic (yes/no) over the 2 year period For the mother: 1. Gestational hypertension as defined by the International Society for Trial of Hypertension in pregnancy (ISSHP): hypertension (blood pressure =140/90mmHg) arising de novo after 20 weeks gestation in the absence of proteinuria 2. Pre-eclampsia as defined by the ISSHP: (blood pressure =140/90mmHg AND significant proteinuria (protein/creatinine ratio of 30 mg/mmol) 3. Onset of labour (spontaneous, induction (method), prelabour cesarean) 4. Mode of delivery (spontaneous vaginal, assisted vaginal, caesarean) Previous secondary outcome measures: 1. For the baby: Two-year developmental outcomes assessed by the PARCA-R performed at 24 months 2. For the mother: 2.1 Pre-eclam | — |
Countries
Austria, Belgium, Czech Republic, England, Estonia, Germany, Italy, Norway, Poland, Spain, United Kingdom
Outcome results
None listed