Improving newborn survival in preterm birth
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2021/03/032429
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
The population of interest is women with singleton or multiple pregnancy at 34 weeks to 36 weeks and 5 days and a high probability of late preterm birth (which extends up to 36 weeks 6 days).
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:
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 more than or equal to 3 cm or effacement more than or equal to 75%). OR
B. Preterm labour with intact membranes, defined as at least 6 regular contractions/hr and one of the following: (i) cervix more than or equal to 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
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 USG
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)
Women with the following conditions will be eligible. Any comorbid conditions will be managed according to local guidelines, and in line with WHO recommendations:
-Women with a history of previous preterm birth
-Women with hypertensive disorders
-Women with a growth impaired foetus
-Women with pre-gestational or gestational diabetes
-Women with HIV/AIDs
1. Ruptured membranes with cervix dilated more than or equal to 3cm or effaced more than or equal to 75%, or with more than 6 contractions per hour (or both)
2. Cervical dilation of more than or equal to 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
- Secondary Outcome Measures
Name Time Method