Betamethasone Dosing Interval - 12 or 24 Hours?
November 7, 2009 updated by: The Cooper Health System
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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Pomona, New Jersey, United States
- AtlantiCare Regional Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Until neonatal discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of INH, NEC, BPD, Blindness
Time Frame: until neonatal discharge
|
until neonatal discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meena Khandelwal, MD, The Cooper Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
March 26, 2007
First Submitted That Met QC Criteria
March 27, 2007
First Posted (Estimate)
March 28, 2007
Study Record Updates
Last Update Posted (Estimate)
November 10, 2009
Last Update Submitted That Met QC Criteria
November 7, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.