Improving newborn survival in late preterm birth
- Conditions
- Health Condition 1: null- Prevention of neonatal deaths by administration of Antenatal Corticosteroids to women with a live fetus/es at risk of imminent preterm birth from 34 weeks 0 days to 35 weeks 6 days gestationHealth Condition 2: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2017/05/008721
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 778
1 Birth planned or expected within 48 hours
2 Gestational age from 34 weeks 0 days to 36 weeks 0 days
3 Women with singleton or multiple pregnancies, where the fetus(es) is(are) alive
4 Women with no clinical signs of severe infection (as per clinical assessment)
5 Women willing and able to provide consent
Women with the following conditions are eligible. Any comorbid conditions will be managed according to local guidelines, and in line with WHO recommendations:
6 Women with a history of previous preterm birth
7 Women with hypertensive disorders
8 Women with a growth impaired fetus
9 Women with pre-gestational or gestational diabetes
10 Women with HIV/AIDs
1 Intrauterine fetal death
2 Major or lethal congenital fetal anomaly identified
3 Clinical suspicion or evidence of clinical chorioamnionitis, as per obstetric care physician assessment
4 Clinical suspicion or evidence of severe infection, as per obstetric care physician assessment
5 No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible
6 Any concurrent or recent (within the past 2 weeks) systemic corticosteroid use during the current pregnancy (outside of trial)
7 Unwilling or unable to provide consent
Currently a participant in another clinical trial related to maternal and neonatal health
8 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