Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
ACSinPROM
A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes
1 other identifier
interventional
194
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2016
Longer than P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedStudy Start
First participant enrolled
March 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedDecember 15, 2022
December 1, 2022
6.5 years
June 5, 2015
December 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Neonatal Morbidity
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
from birth through the first 28 days of life
Secondary Outcomes (11)
Gestational age of baby
measured within the first 24 hours following birth.
Baby's birth weight
measured within the first 24 hours following birth
Intrauterine growth restriction (IUGR)
anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Baby's Head Circumference
measured within the first 24 hours following birth
Newborn Mechanical Ventilatory days
measured from birth to 28 days following birth
- +6 more secondary outcomes
Study Arms (2)
Betamethasone - ACTIVE
EXPERIMENTALBooster Course of Antenatal Steroids consists of Betamethasone \[12 mg intramuscular injection, 24 hours apart X 2 doses\] or if unavailable may give Dexamethasone \[6 mg intramuscularly 12 hours apart x 4 doses\]
normal saline - PLACEBO
PLACEBO COMPARATORNormal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
Interventions
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
Eligibility Criteria
You may qualify if:
- Participants age 18 years or older
- w0d 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
You may not qualify if:
- Known major fetal anomalies
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pediatrixlead
Study Sites (9)
University of South Alabama Medical Center
Mobile, Alabama, 36617, United States
Phoenix Perinatal Associates
Phoenix, Arizona, 85014, United States
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428, United States
Good Samaritan Hospital
San Jose, California, 95008, United States
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Lousiana State University Health Science
Shreveport, Louisiana, 60612, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Swedish Medical Center
Seattle, Washington, 98122-4307, United States
Related Publications (1)
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.
PMID: 36796641DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Porreco, MD
Pediatrix
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2015
First Posted
June 11, 2015
Study Start
March 3, 2016
Primary Completion
August 15, 2022
Study Completion
October 31, 2022
Last Updated
December 15, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share