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Betamethasone Dosing Interval - 12 or 24 Hours?

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ClinicalTrials.gov Identifier: NCT00453141
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : November 10, 2009
Information provided by:
The Cooper Health System

Brief Summary:
The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: dosing of Betamethasone Not Applicable

Detailed Description:
Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Betamethasone Dosing Interval - 12 or 24 Hours?
Study Start Date : April 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Primary Outcome Measures :
  1. The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network) [ Time Frame: Until neonatal discharge ]

Secondary Outcome Measures :
  1. Incidence of INH, NEC, BPD, Blindness [ Time Frame: until neonatal discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
  • Gestational age between 23 and 34 weeks gestational age.
  • Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.

Exclusion Criteria:

  • Patients at <23 or >34 weeks gestational age.
  • Known drug allergy to betamethasone.
  • Given steroid other than betamethasone for lung maturation.
  • Any contraindication to steroid therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453141

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United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Atlanticare Regional Medical Center
Pomona, New Jersey, United States
Sponsors and Collaborators
The Cooper Health System
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Principal Investigator: Meena Khandelwal, MD The Cooper Health System
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ClinicalTrials.gov Identifier: NCT00453141    
Other Study ID Numbers: 06030
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: March 2009
Keywords provided by The Cooper Health System:
Betamethasone for preterm labor
Preterm delivery
Infant Respiratory Distress Syndrome
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents