Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
- Conditions
- Premature Birth
- Interventions
- Other: Normal Saline - PLACEBO
- Registration Number
- NCT02469519
- Lead Sponsor
- Pediatrix
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 194
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Betamethasone - ACTIVE 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 \[6 mg intramuscularly 12 hours apart x 4 doses\] normal saline - PLACEBO Normal Saline - PLACEBO Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
- Primary Outcome Measures
Name Time Method Composite Neonatal Morbidity from birth through the first 28 days of life 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.
- Secondary Outcome Measures
Name Time Method Gestational age of baby measured within the first 24 hours following birth. gestational age of the baby on the day of it's birth
Baby's birth weight measured within the first 24 hours following birth weight of the baby taken with in the first hours following birth
Intrauterine growth restriction (IUGR) anytime during the pregnancy prior to birth (~ 9 months of pregnancy) a measurement done by ultrasound taken at any time during the pregnancy prior to birth
Baby's Head Circumference measured within the first 24 hours following birth a measurement of the baby's head taken within the first hours following birth
Newborn Mechanical Ventilatory days measured from birth to 28 days following birth measurement of the total number of days the baby requires mechanical ventilatory support
Newborn Oxygen support days measured from birth to 28 days following birth measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)
Newborn Surfactant therapy measured within the first 24 hours following birth measurement of the need for newborn surfactant therapy within the first 28 day following birth
time from first dose of study drug to birth measured in days/hours from the time of administration of first study drug until birth. the number of hours/days from the time of the first dose of study drug until birth
Newborn Hospital Days measured within the first 24 hours following birth the number of days that newborn remains in the hospital following its birth.
Pneumothorax measured within the first 24 hours following birth diagnosis of a collapsed lung supported by clinical or radiologic evidence.
Maternal Infectious Morbidity measured within the first 24 hours following birth diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.
Trial Locations
- Locations (9)
Phoenix Perinatal Associates
🇺🇸Phoenix, Arizona, United States
Lousiana State University Health Science
🇺🇸Shreveport, Louisiana, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Presbyterian/St Luke's Hospital
🇺🇸Denver, Colorado, United States
Good Samaritan Hospital
🇺🇸San Jose, California, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States