Clinical trial NCT02469519: Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Premature Birth
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Composite Neonatal Morbidity
timeFrame: from birth through the first 28 days of life
Secondary outcomes:
measure: Gestational age of baby
timeFrame: measured within the first 24 hours following birth.
measure: Baby's birth weight
timeFrame: measured within the first 24 hours following birth
measure: Intrauterine growth restriction (IUGR)
timeFrame: anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
measure: Baby's Head Circumference
timeFrame: measured within the first 24 hours following birth
measure: Newborn Mechanical Ventilatory days
timeFrame: measured from birth to 28 days following birth
measure: Newborn Oxygen support days
timeFrame: measured from birth to 28 days following birth
measure: Newborn Surfactant therapy
timeFrame: measured within the first 24 hours following birth
measure: Newborn Hospital Days
timeFrame: measured within the first 24 hours following birth
measure: Pneumothorax
timeFrame: measured within the first 24 hours following birth
measure: Maternal Infectious Morbidity
timeFrame: measured within the first 24 hours following birth
measure: time from first dose of study drug to birth
timeFrame: measured in days/hours from the time of administration of first study drug until birth.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Perinatal Associates
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Lousiana State University Health Science
state: Louisiana
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Pediatrix
name: Richard Porreco, MD
role: PRINCIPAL_INVESTIGATOR
References: