N/A
Completed N=103,117
Trial of the Use of Antenatal Corticosteroids in Developing Countries
Source: ClinicalTrials.gov NCT01084096 ↗Enrolled (actual)
103,117
Serious AEs
5.7%
Results posted
Dec 2024
Primary outcomePrimary: Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) — 566; 524 Participants — p=0.65
Summary
Multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neonatal Mortality Rate at 28 Days in <5th Percentile Birth Weight Infants (as a Proxy Measure for Prematurity) |
566; 524 | 0.65 |
| SECONDARY Use of Antenatal Corticosteroids in Women at Risk of Preterm Birth in All the Study Clusters |
1,052; 215 | <0.0001 sig |
| SECONDARY Suspected Maternal Infection |
1,207; 867 | <0.0001 sig |
| SECONDARY Maternal Mortality Rate |
106; 97 | — |
| SECONDARY Neonatal Mortality Rate |
1300; 1211 | 0.0127 sig |
| SECONDARY Stillbirth Mortality Rate |
1304; 1264 | 0.0181 sig |
Eligibility Criteria
This is an intent-to-treat design and thus all pregnancy outcomes of women who deliver in the study clusters and provide consent will be collected. Cluster-level inclusion criteria include
- At least 250 deliveries per year.
- Birth attendants within the health cluster will be consented to participate
Participant-level inclusion criteria include all pregnant women living in and delivering in the study cluster who:
- Are between 24 and 36 weeks GA;
- Present with signs of preterm labor, amniotic fluid leakage, hemorrhage, or hypertension;
- Provide consent for injection or present to a facility where it is standard of care.
Exclusion Criteria
- There will not be any specific exclusion criteria for clusters or participants.
Data sourced from ClinicalTrials.gov (NCT01084096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.