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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 65
Updated:3/9/2019
Start Date:March 3, 2016
End Date:July 2022
Contact:Kimberly Maurel, MSN
Email:kimberly_maurel@mednax.com
Phone:7145939171

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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

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.

This is a multicenter randomized double blinded trial that hopes to prospectively evaluate
the impact of one versus two courses of antenatal steroids on the incidence of major neonatal
morbidity including respiratory distress syndrome in pregnant women with a singleton
gestation between 24w0d - 32w6d gestation who have documented premature rupture of the
membranes.

Inclusion Criteria:

- Participants age 18 years or older

- 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:

- 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
We found this trial at
10
sites
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Lan Tran, MD
Phone: 206-624-7730
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Denver, Colorado 80218
Principal Investigator: Richard Porreco, MD
Phone: 303-860-9990
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Fort Worth, Texas
Principal Investigator: April Bleich, MD
Phone: 817-878-5298
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Knoxville, Tennessee 37920
Principal Investigator: Craig Towers, MD
Phone: 865-305-8888
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Long Beach, California 90801
Principal Investigator: Michael Nageotte, MD
Phone: 562-933-2730
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Mobile, Alabama 36604
Principal Investigator: Bassam Rimawi, MD
Phone: 251-415-1000
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Mobile, AL
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New Orleans, Louisiana 70121
Principal Investigator: Sherri Longo, MD
Phone: 504-894-3039
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New Orleans, LA
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Phoenix, Arizona 85014
Principal Investigator: Kevin Huls, MD
Phone: 602-614-0488
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San Jose, California 95124
Principal Investigator: Andrew Combs, MD
Phone: 408-371-7111
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San Jose, CA
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Shreveport, Louisiana 60612
Principal Investigator: David Lewis, MD
Phone: 318-675-7298
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Shreveport, LA
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