Antenatal corticosteroids for women at risk of birth in the late preterm period to improve newborn outcomes
- Conditions
- Preterm birthPregnancy and ChildbirthPreterm labour and delivery
- Registration Number
- ISRCTN11434567
- Lead Sponsor
- World Health Organization
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38609983/ (added 15/04/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- Female
- Target Recruitment
- 13500
The population of interest is women with singleton or multiple pregnancy at 34+0 weeks to 36+5 weeks and a high probability of late preterm birth (which extends up to 36 weeks 6 days). High probability of late preterm birth is defined as birth expected between 12 hours and 7 days
Inclusion criteria (all to be met):
1. Gestational age from 34 weeks 0 days to 36 weeks 5 days
2. 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:
2.1. Membrane rupture without preterm labour (where preterm labour is defined as at least 6 regular uterine contractions/ hr and at least one of the following: cervical dilatation of =3 cm or effacement =75%). OR
2.2. Preterm labour with intact membranes, defined as at least 6 regular contractions/hr and at least one of the following: (i) cervix =3cm dilated or (ii) 75% effaced; OR
2.3. Planned delivery by induction of labour or caesarean section between 24 hours 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
3. Singleton or multiple pregnancies, where the foetus/es (or at least one foetus in a multiple pregnancy) is/are confirmed alive by doppler or ultrasonography
4. Women with no clinical signs of severe infection (as per obstetric care physician’s assessment)
5. Women willing and able to provide consent (or if a minor, provides assent and guardian provides consent)
1. Ruptured membranes with cervix dilated =3 cm or effaced =75%, or with more than 6 contractions per hour (or both)
2. Cervical dilation =8 cm with intact membranes
3. Clinical suspicion or evidence of clinical chorioamnionitis or severe infection, as per obstetric care physician assessment
4. Evidence of non-reassuring foetal status requiring immediate delivery
5. Major or lethal congenital foetal anomaly identified
6. No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible
7. Any systemic corticosteroid use during the current pregnancy (outside of trial)
8. Unwilling or unable to provide consent or assent (including due to active labour)
9. Currently a participant in another clinical trial related to maternal and neonatal health, or previously participated in any ACTION trial
10. Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 defined as 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
- Secondary Outcome Measures
Name Time Method