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Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes

NCT02469519 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2022-12-15

No results posted yet for this study

Summary

This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.

Conditions

  • Premature Birth

Interventions

DRUG

Betamethasone - ACTIVE

antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.

OTHER

Normal Saline - PLACEBO

normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses

Sponsors & Collaborators

  • Pediatrix

    lead OTHER

Principal Investigators

  • Richard Porreco, MD · Pediatrix

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-03
Primary Completion
2022-08-15
Completion
2022-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469519 on ClinicalTrials.gov