Status:
COMPLETED
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
Lead Sponsor:
Obstetrix Medical Group
Conditions:
Preterm Delivery
Eligibility:
FEMALE
18-60 years
Phase:
PHASE4
Brief 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 delive...
Detailed Description
This is a randomized double-blinded placebo-controlled trial. The objective of this study is to evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT00201643
Start Date
November 1 2003
End Date
February 1 2008
Last Update
January 7 2015
Active Locations (22)
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1
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202
2
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States, 85006
3
Tucson Medical Center
Tucson, Arizona, United States, 85712
4
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653