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Sponsored by: |
The Cooper Health System |
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Information provided by: | The Cooper Health System |
ClinicalTrials.gov Identifier: | NCT00453141 |
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 |
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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? |
Estimated Enrollment: | 200 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | March 2008 |
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
Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Meena Khandelwal, MD | 856-342-2491 | khandelwal-meena@cooperhealth.edu |
Contact: Clare E Hansen, RNC, BSN | 856-968-7547 | hansen-clare@cooperhealth.edu |
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 |
Principal Investigator: | Meena Khandelwal, MD | Cooper University Hospital |
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 |
Betamethasone for preterm labor Preterm delivery Infant Respiratory Distress Syndrome |
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 |
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 |