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Brief Title † | A Randomized Trial Comparing the Impact of One Versus Two Courses of ACS on Neonatal Outcome | ||||
Official Title † | A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome | ||||
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. |
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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 (1). 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 (2). Numerous studies have evaluated the safety and efficacy of antenatal corticosteroid (ANC) 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 (3). Since the studies on the duration of the effects of antenatal corticosteroids in the fetus are not conclusive (4), 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 (12). |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Primary Outcome Measure † | Composite neonatal morbidity - respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death. [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ] | ||||
Secondary Outcome Measure † | GA at delivery, birth weight, IUGR/SGA, head circumference, ventilator days, days requiring supplemental O2, need for surfactant therapy, hospital days, pneumothorax, maternal infectious morbidity [ Time Frame: birth to 28days of life ] [ Designated as safety issue: Yes ] | ||||
Condition † | Preterm Delivery | ||||
Intervention † | Drug: Betamethasone (Second course of Antenatal Steroids) Drug: Placebo |
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MEDLINE PMIDs | 7728157, 11275015, 11725806, 11585480, 12066102 | ||||
Links | Protocols' home page on the sponsor's Web site. Click on Protocols and then click the ACS Protocol for more information about this study.  | ||||
Recruitment Information Fields | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 437 | ||||
Start Date † | November 2003 | ||||
Completion Date | February 2008 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00201643 | ||||
Organization ID | OBX0001 | ||||
Secondary IDs †† | OBX0001 | ||||
Study Sponsor † | Obstetrix Medical Group | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Obstetrix Medical Group | ||||
Verification Date | September 2007 | ||||
First Received Date † | September 12, 2005 | ||||
Last Updated Date | June 30, 2008 |