Improving newborn survival in preterm birth

Phase 3

Completed

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 26 weeks 0 days to 33 weeks 6 days gestationHealth Condition 2: P220- Respiratory distress syndrome of newborn

Registration Number: CTRI/2017/04/008326

Lead Sponsor: World Health Organization

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 579

Inclusion Criteria

Trial participants will be pregnant women coming to the hospital for delivery. Participants will be eligible for the trial if

1 Birth planned or expected within 48 hours

2 Gestational age from 26 weeks 0 days to 33 weeks 6 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

Exclusion Criteria

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
1. Neonatal death: death of a live birth within 28 completed days of life. <br/ ><br>2. Stillbirth or neonatal death: Any death of a fetus (post enrolment) or death of a live birth within 28 completed days of life among all enrolled participants <br/ ><br>3. Possible maternal bacterial infection: Occurrence of maternal fever, or clinically suspected or confirmed infection, for which therapeutic antibiotics were used.Timepoint: Randomization to 28 days postpartum

Secondary Outcome Measures