Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
Information source: Mednax Center for Research, Education and Quality
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Birth
Intervention: Betamethasone - ACTIVE (Drug); Normal Saline - PLACEBO (Other)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Mednax Center for Research, Education and Quality Official(s) and/or principal investigator(s):
Thomas J Garite, MD, Principal Investigator, Affiliation: Mednax Center for Research, Education and Quality
Overall contact:
Kimberly Maurel, MSN, Phone: 7145939171, Email: kimberly_maurel@pediatrix.com
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Composite Neonatal Morbidity
Secondary outcome: Gestational age of babyBaby's birth weight Intrauterine growth restriction (IUGR) Baby's Head Circumference Newborn Mechanical Ventilatory days Newborn Oxygen support days Newborn Surfactant therapy Newborn Hospital Days Pneumothorax Maternal Infectious Morbidity
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Kimberly Maurel, MSN, Phone: 7145939171, Email: kimberly_maurel@pediatrix.com
Phoenix Perinatal Associates, Phoenix, Arizona 85014, United States; Not yet recruiting
Ana Bodea-Braescu, MSN, MPH, Phone: 602-614-0488, Email: ana_braescu@pediatrix.com
Thomas H Strong, MD, Phone: 602-677-9234, Email: thomas_strong@obstetrix.com
Thomas H Strong, MD, Principal Investigator
Long Beach Memorial Medical Center, Long Beach, California 90801-1428, United States; Not yet recruiting
Michael Nageotte, MD, Phone: 562-933-2730, Email: Michael_nageotte@pediatrix.com
Deysi Caballero, LVN, Phone: 562-933-2730, Email: dcaballero@memorialcare.org
Michael Nageotte, MD, Principal Investigator
Good Samaritan Hospital, San Jose, California 95008, United States; Not yet recruiting
Andrew Combs, MD, Phone: 408-371-7111, Email: andrew_combs@pediatrix.com
Kimberly Mallory, RN, Phone: 408-371-7111, Email: kimberly_mallory@pediatrix.com
Andrew Combs, MD, Principal Investigator
Presbyterian/St Luke's Hospital, Denver, Colorado 80218, United States; Not yet recruiting
Richard Porreco, MD, Phone: 303-860-9990, Email: richard_porreco@pediatrix.com
Julie Rael, RN, Phone: 303-570-8138, Email: julie_rael@pediatrix.com
Richard Porreco, MD, Principal Investigator
Swedish Medical Center, Seattle, Washington 98122-4307, United States; Not yet recruiting
David Luthy, MD, Phone: 206-386-2101, Email: david_luthy@pediatrix.com
Tina Lopez, RN, Phone: 206-215-3541, Email: tina_lopez@pediatrix.com
David Luthy, MD, Principal Investigator
Additional Information
Starting date: August 2015
Last updated: June 8, 2015
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