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A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT00201643
First received: September 12, 2005
Last updated: September 15, 2011
Last verified: September 2011
Results First Received: September 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Preterm Delivery
Interventions: Drug: Betamethasone or Dexamethasone (2nd course of ACS)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pregnant women were recruited at 18 private (15) and university (3) medical centers from May 2003 through February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
no washout, run-in or transition events occurred between enrollment and group assignment.

Reporting Groups
  Description
"Rescue" Course of Betamethasone or Dexamethasone Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
Placebo (Normal Saline)

Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.

The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.


Participant Flow:   Overall Study
    "Rescue" Course of Betamethasone or Dexamethasone     Placebo (Normal Saline)  
STARTED     223     214  
COMPLETED     218     210  
NOT COMPLETED     5     4  
Withdrawal by Subject                 5                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
"Rescue" Course of Betamethasone or Dexamethasone Receive 2nd "Rescue" Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart.
Placebo (Normal Saline)

Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.

The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart.

Total Total of all reporting groups

Baseline Measures
    "Rescue" Course of Betamethasone or Dexamethasone     Placebo (Normal Saline)     Total  
Number of Participants  
[units: participants]
  223     214     437  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     223     214     437  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29  ± 6     29  ± 6     29  ± 6  
Gender  
[units: participants]
     
Female     223     214     437  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     223     214     437  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite Neonatal Morbidity < 34 Weeks Gestation at Time of Birth.   [ Time Frame: From birth to 28 days of life ]

2.  Secondary:   Gestational Age at (@) Delivery   [ Time Frame: gestational age at delivery in weeks of gestation ]

3.  Secondary:   Neonatal Birth Weight Reported in Grams   [ Time Frame: At time of Birth ]

4.  Secondary:   Interuterine Growth Restriction (IUGR) or Small for Gestational Age(SGA)in Babies Delivering at < 34 Weeks Gestation.   [ Time Frame: Measured at birth. ]

5.  Secondary:   Neonatal Head Circumference Taken at Time of Birth.   [ Time Frame: Birth ]

6.  Secondary:   Number of Babies Who Required Ventilatory Support Within the First 28 Days of Life.   [ Time Frame: birth to 28 days of life ]

7.  Secondary:   Number of Neonates Who Required Surfactant Therapy After Birth.   [ Time Frame: Birth to 28 days of life ]

8.  Secondary:   Number of Neonates With Pneumothorax   [ Time Frame: birth to 28 days of life ]

9.  Secondary:   Maternal Infectious Morbidity.   [ Time Frame: Up to 28 days after giving birth ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kimberly A. Maurel, MSN, CNS
Organization: Obstetrix Medical Group, Inc.
phone: 714-593-9171
e-mail: kimberly_maurel@pediatrix.com


Publications:

Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT00201643     History of Changes
Other Study ID Numbers: OBX0001, OBX0001
Study First Received: September 12, 2005
Results First Received: September 7, 2010
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board