Betamethasone Dosing Interval - 12 or 24 Hours?

Preterm Delivery Clinical Trial

Official title:

Betamethasone Dosing Interval - 12 or 24 Hours?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453141
• Other study ID #: 06030
• Status: Completed
• Phase: N/A
• First received: March 26, 2007
• Last updated: November 7, 2009
• Start date: April 2006
• Est. completion date: October 2009

Study information

• Verified date: March 2009
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Intervention

Drug:
• dosing of Betamethasone

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey
United States	Atlanticare Regional Medical Center	Pomona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Until neonatal discharge
Secondary	Incidence of INH, NEC, BPD, Blindness		until neonatal discharge