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...
Date First Received: September 12, 2005
Last Updated: June 30, 2008
Verified by: Obstetrix Medical Group, September 2007
Clinical Trial Phase: Phase 4 | Start Date: November 2003
Overall Status: Completed
Estimated Enrollment: 437
Brief Summary
Official Title: “A Randomized Double-Blinded Study Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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).
Outcome Measures for this Clinical Trial
Primary:
- Composite neonatal morbidity - respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or perinatal death. birth to 28days of life Yes
Secondary:
- 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 birth to 28days of life Yes
Criteria for Participation in this Clinical Trial
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 (eg.
- 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 (eg. HIV, active TB)
- Participation in conflicting study
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Obstetrix Medical Group
Banner Good Sammaritan Hospital
Phoenix Arizona 85006 United States
Desert Good Samaritan Hospital
Mesa Arizona 85202 United States
Tucson Medical Center
Tucson Arizona 85712 United States
Good Samaritan Hospital
San Jose California 95124 United States
Long Beach Memorial Medical Center
Long Beach California 90801-1428 United States
Saddleback Memorial Medical Center
Laguna Hills California 92653 United States
University of Sourthern California-Irvine Medical Center
Orange California 92868 United States
Presbyterian/St Luke's Hospital
Denver Colorado 80218 United States
Rose Medical Center
Denver Colorado 80220 United States
Skyridge Medical Center
Lonetree Colorado 80124 United States
Swedish Medical Center
Denver Colorado 80110 United States
Mercy Medical Center
Des Moines Iowa 50314 United States
Tufts-New England Medical Center
Boston Massachusetts 02111 United States
Saint Luke's Hospital, Kansas City
Kansas City Missouri 64111 United States
Saint John's Regional Health Center
Springfield, Missouri 65804 United States
Sunrise Medical Center
Las Vegas Nevada 89109 United States
University Med. Ctr. of Southern Nevada
Las Vegas Nevada 89102 United States
Erlanger Medical Center
Chattanooga Tennessee 37403 United States
University of Tennessee Medical Center
Knoxville Tennessee 37920 United States
Evergreen Hospital
Kirkland Washington 98034 United States
Swedish Medical Center
Seattle Washington 98122-4307 United States
Overall Clinical Trial Officials and Contacts
Kimberly Maurel, RN, MSN, CNS Study Director Obstetrix Medical Group, Inc.
Related Publications
References
[No authors listed] Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consens Statement. 1994 Feb 28-Mar 2;12(2):1-24. Review.
Vermillion ST, Soper DE, Newman RB. Is betamethasone effective longer than 7 days after treatment? Obstet Gynecol. 2001 Apr;97(4):491-3.
[No authors listed] Antenatal corticosteroids revisited: repeat courses. NIH Consens Statement. 2000 Aug 17-18;17(2):1-18.
Guinn DA, Atkinson MW, Sullivan L, Lee M, MacGregor S, Parilla BV, Davies J, Hanlon-Lundberg K, Simpson L, Stone J, Wing D, Ogasawara K, Muraskas J. Single vs weekly courses of antenatal corticosteroids for women at risk of preterm delivery: A randomized controlled trial. JAMA. 2001 Oct 3;286(13):1581-7.
Caughey AB, Parer JT. Recommendations for repeat courses of antenatal corticosteroids: a decision analysis. Am J Obstet Gynecol. 2002 Jun;186(6):1221-6; discussion 1226-9.
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00201643
Study ID Number: OBX0001
ClinicalTrials.gov Identifier: NCT00201643
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
