Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201643
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2005-09-12
Brief Title:
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids ACS on Neonatal Outcome
Sponsor:
Obstetrix Medical Group
Organization:
Pediatrix
Study Overview
Official Title:
A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACS
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 delivering prior to 34 weeks gestation
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 morbidity including respiratory distress syndrome in patients delivering prior to 34 weeks gestation in a randomized prospective fashion
Preterm delivery occurs in approximately 10 of all deliveries in the United States Preterm birth is the cause of 75 of neonatal mortality not mentioning the significantly increased morbidity from respiratory distress syndrome intraventricular hemorrhage necrotizing enterocolitis and sepsis Numerous studies have evaluated the safety and efficacy of antenatal corticosteroid ACS administration in threatened preterm labor
National Institutes of Health NIH first consensus conference in 1994 evaluated the research in this field Conclusions included the clear evidence that antenatal corticosteroids decrease the incidence of RDS in infants born at 29-34 weeks gestation with a decrease in RDS severity for infants born at 24-28 weeks gestation and a decrease in the incidence of intraventricular hemorrhage in infants born at 24-28 weeks gestation without harm to mother or fetus Their recommendation was to give a single course of corticosteroids to all pregnant women between 24 and 34 weeks gestation who are at risk of preterm delivery within 7 days
Since the studies on the duration of the effects of antenatal corticosteroids in the fetus are not conclusive many obstetricians repeat corticosteroids weekly or bi-weekly to patients continuing to be at risk for preterm delivery Lacking scientific evidence many investigators have performed retrospective analyses regarding the effects of single-course versus multiple-course antenatal corticosteroids
The NIH consensus panel reconvened in 2000 and concluded that studies regarding repeated courses of corticosteroids are suggestive of possible benefits especially in reduction of RDS however design flaws limit their validity
The more recent publication from Caughey and Parer examined the literature for evidence regarding a dose response of the benefits and detriments of antenatal corticosteroids Based on their complex mathematical analysis they recommend all fetus between 24 and 34 weeks gestation at risk for preterm delivery should be given a first course of ANC If the risk of preterm delivery persists the next course should be given 2 weeks later for a maximum of two courses Consistent with all previous articles the call for a well designed randomized controlled trial is made
Preterm delivery occurs in approximately 10 of all deliveries in the United States Preterm birth is the cause of 75 of neonatal mortality not mentioning the significantly increased morbidity from respiratory distress syndrome intraventricular hemorrhage necrotizing enterocolitis and sepsis Numerous studies have evaluated the safety and efficacy of antenatal corticosteroid ACS administration in threatened preterm labor
National Institutes of Health NIH first consensus conference in 1994 evaluated the research in this field Conclusions included the clear evidence that antenatal corticosteroids decrease the incidence of RDS in infants born at 29-34 weeks gestation with a decrease in RDS severity for infants born at 24-28 weeks gestation and a decrease in the incidence of intraventricular hemorrhage in infants born at 24-28 weeks gestation without harm to mother or fetus Their recommendation was to give a single course of corticosteroids to all pregnant women between 24 and 34 weeks gestation who are at risk of preterm delivery within 7 days
Since the studies on the duration of the effects of antenatal corticosteroids in the fetus are not conclusive many obstetricians repeat corticosteroids weekly or bi-weekly to patients continuing to be at risk for preterm delivery Lacking scientific evidence many investigators have performed retrospective analyses regarding the effects of single-course versus multiple-course antenatal corticosteroids
The NIH consensus panel reconvened in 2000 and concluded that studies regarding repeated courses of corticosteroids are suggestive of possible benefits especially in reduction of RDS however design flaws limit their validity
The more recent publication from Caughey and Parer examined the literature for evidence regarding a dose response of the benefits and detriments of antenatal corticosteroids Based on their complex mathematical analysis they recommend all fetus between 24 and 34 weeks gestation at risk for preterm delivery should be given a first course of ANC If the risk of preterm delivery persists the next course should be given 2 weeks later for a maximum of two courses Consistent with all previous articles the call for a well designed randomized controlled trial is made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OBX0001 | OTHER | Obstetrix Medical Group | None |