A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
NCT ID: NCT00201643
Last Updated: 2015-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
437 participants
INTERVENTIONAL
2003-11-30
2008-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1 Test group
Receive 2nd Course = Study drug (betamethasone or dexamethasone)
Betamethasone or Dexamethasone (2nd course of ACS)
Course of Betamethasone or Dexamethasone
2 - Control
Placebo group = received placebo course
Placebo
Course of Placebo (NS)
Interventions
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Betamethasone or Dexamethasone (2nd course of ACS)
Course of Betamethasone or Dexamethasone
Placebo
Course of Placebo (NS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Obstetrix Medical Group
INDUSTRY
Responsible Party
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Principal Investigators
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Kimberly Maurel, RN, MSN, CNS
Role: STUDY_DIRECTOR
Obstetrix Medical Group, Inc.
Locations
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Desert Good Samaritan Hospital
Mesa, Arizona, United States
Banner Good Sammaritan Hospital
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Saddleback Memorial Medical Center
Laguna Hills, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
University of Sourthern California-Irvine Medical Center
Orange, California, United States
Good Samaritan Hospital
San Jose, California, United States
Swedish Medical Center
Denver, Colorado, United States
Presbyterian/St Luke's Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Skyridge Medical Center
Lonetree, Colorado, United States
Mercy Medical Center
Des Moines, Iowa, United States
Tufts-New England Medical Center
Boston, Massachusetts, United States
Saint Luke's Hospital, Kansas City
Kansas City, Missouri, United States
Saint John's Regional Health Center
Springfield, Missouri, United States
University Med. Ctr. of Southern Nevada
Las Vegas, Nevada, United States
Sunrise Medical Center
Las Vegas, Nevada, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Evergreen Hospital
Kirkland, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consens Statement. 1994 Feb 28-Mar 2;12(2):1-24.
Vermillion ST, Soper DE, Newman RB. Is betamethasone effective longer than 7 days after treatment? Obstet Gynecol. 2001 Apr;97(4):491-3. doi: 10.1016/s0029-7844(00)01178-9.
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. doi: 10.1001/jama.286.13.1581.
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. doi: 10.1067/mob.2002.123742.
Other Identifiers
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OBX0001
Identifier Type: OTHER
Identifier Source: secondary_id
OBX0001
Identifier Type: -
Identifier Source: org_study_id
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