Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
NCT ID: NCT02469519
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
194 participants
INTERVENTIONAL
2016-03-03
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Betamethasone - ACTIVE
Booster Course of Antenatal Steroids consists of Betamethasone \[12 mg intramuscular injection, 24 hours apart X 2 doses\] or if unavailable may give Dexamethasone \[6 mg intramuscularly 12 hours apart x 4 doses\]
Betamethasone - ACTIVE
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
normal saline - PLACEBO
Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
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
Interventions
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Betamethasone - ACTIVE
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 24w0d to 32w6d weeks gestation
* Singleton pregnancy
* Received first course of ACS at or prior to 31w6d gestation
* Began first course of ACS at least 7 days ( =/\> 168 hours) prior to randomization
* Expectant management planned
* Premature Ruptured membranes (PROM) before onset of labor
Exclusion Criteria
* Multiple gestation
* Not a candidate for expectant management
* Clinical chorioamnionitis (two or more of the following: temperature \> 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia \>100 bpm; fetal tachycardia \>160 bpm; maternal White Blood Cell (WBC) count \>20 X 109/L; C-Reactive Protein (CRP) \> 5.9
* Already receiving corticosteroids for another condition
* Any contraindications to the maternal use of corticosteroids
18 Years
65 Years
FEMALE
Yes
Sponsors
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Pediatrix
OTHER
Responsible Party
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Principal Investigators
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Richard Porreco, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatrix
Locations
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University of South Alabama Medical Center
Mobile, Alabama, United States
Phoenix Perinatal Associates
Phoenix, Arizona, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Good Samaritan Hospital
San Jose, California, United States
Presbyterian/St Luke's Hospital
Denver, Colorado, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Lousiana State University Health Science
Shreveport, Louisiana, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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Porreco R, Garite TJ, Combs CA, Maurel K, Huls CK, Baker S, Fortner KB, Longo SA, Nageotte M, Lewis D, Tran L; Obstetrix Collaborative Research Network. Booster course of antenatal corticosteroids after preterm prelabor rupture of membranes: a double-blind randomized trial. Am J Obstet Gynecol MFM. 2023 May;5(5):100896. doi: 10.1016/j.ajogmf.2023.100896. Epub 2023 Feb 14.
Other Identifiers
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OBX0034
Identifier Type: -
Identifier Source: org_study_id