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Betamethasone Dosing Interval - 12 or 24 Hours?

Information source: The Cooper Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Delivery

Intervention: dosing of Betamethasone (Drug)

Phase: N/A

Status: Completed

Sponsored by: The Cooper Health System

Official(s) and/or principal investigator(s):
Meena Khandelwal, MD, Principal Investigator, Affiliation: 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.

Clinical Details

Official title: Betamethasone Dosing Interval - 12 or 24 Hours?

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

Primary outcome: 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: Incidence of INH, NEC, BPD, Blindness

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.


Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Female.


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.

Locations and Contacts

Cooper University Hospital, Camden, New Jersey 08103, United States

Atlanticare Regional Medical Center, Pomona, New Jersey, United States

Additional Information

Related publications:

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.

Starting date: April 2006
Last updated: November 7, 2009

Page last updated: August 23, 2015

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