Betamethasone Dosing Interval - 12 or 24 Hours?

The Cooper Health System200 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Preterm Delivery

Interventions

dosing of BetamethasoneDRUG

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (2)

Cooper University Hospital

Camden, New Jersey, United States

Atlanticare Regional Medical Center

Pomona, New Jersey, United States

Outcomes

Primary Outcomes

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 Outcomes

Incidence of INH, NEC, BPD, Blindness

Time frame: until neonatal discharge

Data from ClinicalTrials.gov

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