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Betamethasone Dosing Interval - 12 or 24 Hours?

Primary Purpose

Preterm Delivery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dosing of Betamethasone
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Delivery focused on measuring Betamethasone for preterm labor, Preterm delivery, Infant Respiratory Distress Syndrome

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Cooper University Hospital
  • Atlanticare Regional Medical Center

Outcomes

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)

Secondary Outcome Measures

Incidence of INH, NEC, BPD, Blindness

Full Information

First Posted
March 26, 2007
Last Updated
November 7, 2009
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00453141
Brief Title
Betamethasone Dosing Interval - 12 or 24 Hours?
Official Title
Betamethasone Dosing Interval - 12 or 24 Hours?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Delivery
Keywords
Betamethasone for preterm labor, Preterm delivery, Infant Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dosing of Betamethasone
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of INH, NEC, BPD, Blindness
Time Frame
until neonatal discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meena Khandelwal, MD
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Atlanticare Regional Medical Center
City
Pomona
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
4561295
Citation
Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.
Results Reference
background

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