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Betamethasone Dosing Interval - 12 or 24 Hours?
This study is currently recruiting participants.
Verified by The Cooper Health System, March 2007
First Received: March 26, 2007   Last Updated: March 29, 2007   History of Changes
Sponsored by: The Cooper Health System
Information provided by: The Cooper Health System
ClinicalTrials.gov Identifier: NCT00453141
  Purpose

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 Intervention
Preterm Delivery
Drug: dosing of Betamethasone

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title: Betamethasone Dosing Interval - 12 or 24 Hours?

Resource links provided by NLM:


Further study details as provided by The Cooper Health System:

Primary Outcome Measures:
  • 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)
  • It would be useful to know if administration of betamethasone at an interval of less than 24 hours would have a positive impact on decreasing the incidence of RDS.

Estimated Enrollment: 200
Study Start Date: April 2006
Estimated Study Completion Date: March 2008
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.
  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453141

Contacts
Contact: Meena Khandelwal, MD 856-342-2491 khandelwal-meena@cooperhealth.edu
Contact: Clare E Hansen, RNC, BSN 856-968-7547 hansen-clare@cooperhealth.edu

Locations
United States, New Jersey
Atlanticare Regional Medical Center Recruiting
Pomona, New Jersey, United States
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Meena Khandelwal, MD     856-342-2491     khandelwal-meena@cooperhealth.edu    
Sponsors and Collaborators
The Cooper Health System
Investigators
Principal Investigator: Meena Khandelwal, MD Cooper University Hospital
  More Information

Publications:
Study ID Numbers: 06030
Study First Received: March 26, 2007
Last Updated: March 29, 2007
ClinicalTrials.gov Identifier: NCT00453141     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by The Cooper Health System:
Betamethasone for preterm labor
Preterm delivery
Infant Respiratory Distress Syndrome

Study placed in the following topic categories:
Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Pregnancy Complications
Hormone Antagonists
Obstetric Labor, Premature
Betamethasone sodium phosphate
Obstetric Labor Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids
Hormones
Sodium phosphate
Betamethasone
Premature Birth

Additional relevant MeSH terms:
Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Respiratory System Agents
Pregnancy Complications
Obstetric Labor, Premature
Betamethasone sodium phosphate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Obstetric Labor Complications
Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Therapeutic Uses
Betamethasone
Premature Birth

ClinicalTrials.gov processed this record on September 10, 2009