Prematurity Pregnancy and Childbirth Prematurity
Conditions
Interventions
Participants are randomly allocated using computer generated envelope randomisation to one of three study arms. Allocations will be stratified by gestation (23+0-27+7 weeks, and 28+0- 31+6 weeks gesta
Sponsors
Cork University Maternity Hospital
University College Cork
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Neonatal inclusion criteria: 1. Infants born at less than 32 weeks gestational age (from 23+0 weeks’ up to and including 31+6 weeks’ gestational age) 2. Vaginal and Caesarean deliveries Maternal inclusion criteria: Informed antenatal consent
Exclusion criteria
Exclusion criteria: Neonatal Exclusion criteria: 1. Major congenital anomaly (defined as those that are at high risk of neonatal death or require postnatal surgery) 2. Monochorionic twins with known or suspected twin to twin transfusion syndrome (TTTS) +/- significant growth discordance (>10%) 3. Hydrops fetalis (any aetiology) 4. Known Rh sensitized pregnancy 5. Cord prolapse Maternal Exclusion criteria: 1. Inability to obtain informed consent 2. Severe or multiple maternal illnesses, including bleeding from placenta praevia, clinical suspicion of placental abruption or accreta, uterine rupture and other causes of maternal coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal outcome measure: Brain activity in the newborn infant is measured using electroencephalogram (EEG) and near-infrared spectroscopy (NIRS) 6 and 12 hours post-partum. Maternal outcome measure: Maternal hemoglobin is measured at 24-36 hours post-partum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcome measures: 1. Maternal Postpartum hemorrhage incidence is determined at 24 hours after delivery 2. Maternal estimated blood loss is determined up to 1 hour after delivery 3. Maternal blood transfusion is determined up to 5 days after delivery 4. Length of third stage of labor is determined up to 1 hour after birth 5. Use of uterotonic agents is determined up to 1 hour after birth 6. Manual removal of placenta is determined up to 1 hour after birth 7. Operating time for cesarean delivery is determined up to 3 hour after birth Neonatal Outcome measures: 1. Neonatal Immediate Outcomes, measured by APGAR scores (1 and 5 minute) and Delivery Room interventions (oxygen concentration, intubation, cardiac compressions and medications) 2. Neonatal Admission Outcomes, measured by temperature, blood pressure, and blood sugar on admission 3. Neonatal haemodynamic outcome, measured by mean blood pressure, number of volume challenges, inotropic support and urinary output (ml/kg/day) over first 24 hours of life. All infants will also have measurements of systemic blood flow measured by echocardiography at 12 +/- 3 hours of life. 4. Neonatal CNS outcomes: Cerebral tissue oxygenation, measured by NIRS at 6, 12 and 24 hours. Cerebral activity measured by EEG at 6, 12 and 24 hours. Intravventricular hemorrhage or Periventricular leukomalacia measured by cranial ultrasound at days 1, 7 and 28 of life 5. Neonatal Haematological outcomes: Hemoglobin measured by blood sampling at 1 and 12 hours of life. Peak serum bilirubin over first 2 months of life. Number of blood transfusions required over first 2 months of life. 6. Neonatal Respiratory outcomes: Intubation, Surfactant, Mechanical ventilator days, Bronchopulmonary dysplasia (oxygen requirement a | — |
Countries
Ireland
Outcome results
None listed