Phase 4
Completed N=437
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
Source: ClinicalTrials.gov NCT00201643 ↗Enrolled (actual)
437
Serious AEs
8.0%
Results posted
Mar 2011
Primary outcomePrimary: Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. — 71; 105 participants — p=0.002
Summary
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks' gestation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth. |
71; 105 | 0.002 sig |
| SECONDARY Gestational Age at (@) Delivery |
33.1; 33.0 | — |
| SECONDARY Neonatal Birth Weight Reported in Grams |
1905; 1920 | — |
| SECONDARY Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation. |
25; 20 | — |
| SECONDARY Neonatal Head Circumference Taken at Time of Birth. |
30.2; 30.0 | — |
| SECONDARY Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life. |
70; 95 | — |
| SECONDARY Number of Neonates Who Required Surfactant Therapy After Birth. |
70; 99 | — |
| SECONDARY Number of Neonates With Pneumothorax |
4; 4 | — |
| SECONDARY Maternal Infectious Morbidity. |
8; 10 | — |
Eligibility Criteria
Inclusion Criteria
- 25 to 32 6/7 weeks gestation
- Singleton or twin gestation
- Received 1st course of betamethasone prior to 30 weeks' gestation
- Began 1st course of betamethasone at least 14 days prior to randomization
- Risk of delivery in next 7 days due to either maternal or fetal complication (e.g. preterm labor, severe preeclampsia, IUGR, etc.)
- Intact membranes
Exclusion Criteria
- Known major fetal anomalies (eg: anencephaly, renal agenesis etc…)
- High order multiple gestation (triplets or higher)
- Cervical dilation > 5 cm
- Clinical chorioamnionitis prior to initiation of second course (two or more of the following; antepartum temperature > 38ºC (100.4ºF), uterine tenderness, foul smelling vaginal discharge or amniotic fluid, maternal tachycardia (>100beats/min), fetal tachycardia (>160 beats/min), or white blood cell count >20x109/L.define)
- Ruptured membranes prior to initiation of second course of betamethasone
- Already receiving corticosteroids for other conditions (e.g. Lupus, asthma)
- Maternal condition contraindicating the use of steroids (e.g. HIV, active Tuberculosis)
- Participation in conflicting study
Data sourced from ClinicalTrials.gov (NCT00201643). 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.