Late preterm birth
Conditions
Interventions
Dexamethasone Phosphate
Betamethasone phosphate
Normal Saline
Sponsors
World Health Organization
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Gestational age from 34 weeks 0 days to 36 weeks 5 days • High probability of late preterm birth (up to 36+6 weeks) defined as birth expected between 12 hours and 7 days after randomization as a result of: A. Membrane rupture without preterm labour (where preterm labour is defined as at least 6 regular uterine contractions/ hr and any one of the following: cervical dilatation of = 3 cm or effacement =75%). OR B. Preterm labour with intact membranes, defined as at least 6 regular contractions/hr and one of the following: (i) cervix =3cm dilated or (ii) 75% effaced; OR C . Planned delivery by induction of labour or caesarean section between 24hours and 7 days, as deemed necessary by the provider. An induction must be scheduled to start by 36+5 weeks at the latest, whereas a caesarean delivery must be scheduled by 36+6 weeks at the latest • Singleton or multiple pregnancies, where the foetus/es (or at least one foetus in a multiple pregnancy) is/are confirmed alive by doppler or USG • Women with no clinical signs of severe infection (as per obstetric care physician’s assessment) • Women willing and able to provide consent (or if a minor, provides assent and guardian provides consent) Women with the following conditions will be eligible. Any comorbid conditions will be managed according to local guidelines, and in line with WHO recommendations: o Women with a history of previous preterm birth o Women with hypertensive disorders o Women with a growth impaired foetus o Women with pre-gestational or gestational diabetes o Women with HIV/AIDs
Exclusion criteria
Exclusion criteria: • Ruptured membranes with cervix dilated = 3cm or effaced =75%, or with more than 6 contractions per hour (or both) • Cervical dilation = 8 cm with intact membranes • Clinical suspicion or evidence of clinical chorioamnionitis or severe infection, as per obstetric care physician assessment • Evidence of non-reassuring foetal status requiring immediate delivery • Major or lethal congenital foetal anomaly identified • No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible • Any systemic corticosteroid use during the current pregnancy (outside of trial) • Unwilling or unable to provide consent or assent (including due to active labour) • Currently a participant in another clinical trial related to maternal and neonatal health, or previously participated in any ACTION trial • Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Stillbirth (post randomization) OR neonatal death within 72 hours of birth OR use of respiratory support within 72 hours of birth or until discharge from hospital, whichever is earlier. Use of respiratory support consists of any one of the following: (i) use of mechanical ventilation (ii) continuous use of CPAP for 12 hours or more with an FiO2 =0.4 at any time (iii) continuous use of supplementary oxygen for 24 hours or more with an FiO2 =0.4 at any time | — |
Secondary
| Measure | Time frame |
|---|---|
| Newborn: Efficacy outcomes: (i) Stillbirths (ii) Neonatal death within 72 hours, 7 days, 28 days of birth (iii) Resuscitation at birth i.e. use of positive pressure ventilation (iv) Severe respiratory distress (SRD) within 72 hours after birth or until discharge from hospital, whichever is earlier. SRD is defined as any of the following clinical signs: respiratory rate =70/ min, chest indrawing, grunting, or SpO2 less than 90%, any of which are present at two or more consecutive 6 hourly assessments. (v) Use of respiratory support i.e. any one of the following: (i) mechanical ventilation (ii) continuous use of CPAP for 12 hours or more with an FiO2 =0.4 at any time (iii) continuous use of supplementary oxygen for 24 hours or more with an FiO2 =0.4 at any time (vi) Still birth OR neonatal death in 72h OR mechanical ventilation OR need for very high CPAP settings (=8 cm water pressure and =0.7 FiO2) in 72h after birth (vii) Cause specific mortality Safety outcomes: (i) Clinically suspected neonatal sepsis (=7d) (ii) Neonatal hypoglycaemia (blood glucose < 45 mg% at 2, 6, 12, 24 or 36 h, or detected anytime < 36 h based on a test because of clinical suspicion) Health service utilization outcomes: (i) Admission to neonatal care unit (ii) Duration of hospitalization (iii) Any parenteral antibiotic use Maternal Safety outcomes: (i) Possible maternal bacterial infection during hospital admission: Occurrence of maternal fever, or clinically suspected or confirmed infection, for which therapeutic antibiotics were used (ii) Chorioamnionitis (iii) Post-partum endometritis (iv) Maternal death (from time of randomization to 28 completed days after birth) | — |
Countries
Kenya
Contacts
Public ContactJohn Kinuthia
Head of Research and Programs at Kenyatta National Hospital
Outcome results
None listed