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 gestation Health Condition 2: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention1: Dexamethasone: Dose- 6 mg
Route of administration- Intramuscular(IM)
Frequency and TOTAL duration of therapy-single course-administered every 12 hours, to a total of four (4) doses (ti
Sponsors
World Health Organization
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Any baby death a.Neonatal death (death of a liveborn within 28 completed days of life) b. Stillbirth or neonatal death (any death of a fetus (post enrollment), or death of a live birth within 28 completed days of life among all enrolled participants. 2 Severe respiratory distress of the neonate 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
| Measure | Time frame |
|---|---|
| 3. Compliance / other study measures Compliance with study allocation Total number of ACS doses received1 Time from randomization to birth (days) Time from initiation of first dose (ACS or placebo) to birth (days) Gestational age at birthTimepoint: Randomization until birth;Apgar score at 5 minutesTimepoint: first 5 minutes of life;ChorioamnionitisTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only);Early neonatal deathTimepoint: birth to 7 completed days of life;Maternal death (from time of enrolment to 28 completed days)Timepoint: randomization to 28 days postpartum;Maternal fever â?¥38.0 C after enrolment (on any one occasion during hospital admission)Timepoint: Randomization to 28 days postpartum;Neonatal hypoglycaemiaTimepoint: birth to 28 days of life (during initial postnatal hospitalization only);Non-obstetric infection (excluding malaria)Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only);Postpartum endometritisTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only);Process of care outcomes 2.Health service utilization Length of hospital stay after birth Admission to a special care unit Length of admission to special care unit (days) Readmission for health care at the facility Length of readmission (days) Number of readmissions to health facility Cause of readmission to health facilityTimepoint: Randomization to 28 days postpartum (during postpartum admission/s only);Process of care outcomes Mother: 1. Measure of care given to woman: Therapeutic antibiotics for suspected or confirmed infection (obstetric or non-obstetric) Number of days of therapeutic antibiotic use Any antibiotic use (prophylactic or therapeutic)Timepoint: Randomization to 28 days postpartum (during postpartum admission/s only);Process of care outcomes Mother: 2. Health service utilization Mean length of total maternal hospitalization for delivery (days) Any postpartum maternal | — |
Countries
Bangladesh, India, Kenya, Nigeria, Pakistan
Contacts
Public ContactDr Shivaprasad S Goudar
KLE Univeristys J N Medical College
Outcome results
None listed