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Sponsored by: |
Obstetrix Medical Group |
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Information provided by: | Obstetrix Medical Group |
ClinicalTrials.gov Identifier: | NCT00201643 |
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.
Condition | Intervention | Phase |
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Preterm Delivery |
Drug: Betamethasone (Second course of Antenatal Steroids) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome |
Enrollment: | 437 |
Study Start Date: | November 2003 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 Test group: Active Comparator
Receive 2nd Course = Study drug (betamethasone or dexamethesone)
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Drug: Betamethasone (Second course of Antenatal Steroids)
Course of Betamethasone vs. Placebo (NS)
Drug: Placebo
Course of Betamethasone vs. Placebo (NS)
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2 - Control: Placebo Comparator
Placebo group = received placebo course
|
Drug: Betamethasone (Second course of Antenatal Steroids)
Course of Betamethasone vs. Placebo (NS)
Drug: Placebo
Course of Betamethasone vs. Placebo (NS)
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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).
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Banner Good Sammaritan Hospital | |
Phoenix, Arizona, United States, 85006 | |
Desert Good Samaritan Hospital | |
Mesa, Arizona, United States, 85202 | |
Tucson Medical Center | |
Tucson, Arizona, United States, 85712 | |
United States, California | |
Good Samaritan Hospital | |
San Jose, California, United States, 95124 | |
Long Beach Memorial Medical Center | |
Long Beach, California, United States, 90801-1428 | |
Saddleback Memorial Medical Center | |
Laguna Hills, California, United States, 92653 | |
University of Sourthern California-Irvine Medical Center | |
Orange, California, United States, 92868 | |
United States, Colorado | |
Presbyterian/St Luke's Hospital | |
Denver, Colorado, United States, 80218 | |
Rose Medical Center | |
Denver, Colorado, United States, 80220 | |
Skyridge Medical Center | |
Lonetree, Colorado, United States, 80124 | |
Swedish Medical Center | |
Denver, Colorado, United States, 80110 | |
United States, Iowa | |
Mercy Medical Center | |
Des Moines, Iowa, United States, 50314 | |
United States, Massachusetts | |
Tufts-New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Missouri | |
Saint Luke's Hospital, Kansas City | |
Kansas City, Missouri, United States, 64111 | |
Saint John's Regional Health Center | |
Springfield,, Missouri, United States, 65804 | |
United States, Nevada | |
Sunrise Medical Center | |
Las Vegas, Nevada, United States, 89109 | |
University Med. Ctr. of Southern Nevada | |
Las Vegas, Nevada, United States, 89102 | |
United States, Tennessee | |
Erlanger Medical Center | |
Chattanooga, Tennessee, United States, 37403 | |
University of Tennessee Medical Center | |
Knoxville, Tennessee, United States, 37920 | |
United States, Washington | |
Evergreen Hospital | |
Kirkland, Washington, United States, 98034 | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122-4307 |
Study Director: | Kimberly Maurel, RN, MSN, CNS | Obstetrix Medical Group, Inc. |
Responsible Party: | Obstetrix Medical Group, Inc. ( Kimberly Maurel ) |
Study ID Numbers: | OBX0001, OBX0001 |
Study First Received: | September 12, 2005 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00201643 |
Health Authority: | United States: Institutional Review Board |
Preterm Labor Preterm delivery |
Betamethasone-17,21-dipropionate Sodium phosphate Pregnancy Complications Betamethasone sodium phosphate |
Obstetric Labor, Premature Obstetric Labor Complications Betamethasone Premature Birth |
Anti-Inflammatory Agents Respiratory System Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Hormones Glucocorticoids Pharmacologic Actions |