Betamethasone Dosing Interval - 12 or 24 Hours?

This study has been completed.
Sponsor:
Information provided by:
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT00453141
First received: March 26, 2007
Last updated: November 7, 2009
Last verified: March 2009
  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: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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) [ Time Frame: Until neonatal discharge ]

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

Estimated Enrollment: 200
Study Start Date: April 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Meena Khandelwal, MD The Cooper Health System
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00453141     History of Changes
Other Study ID Numbers: 06030
Study First Received: March 26, 2007
Last Updated: November 7, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014