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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
194
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
University of South Alabama Medical Center
Mobile, Alabama, United States
Phoenix Perinatal Associates
Phoenix, Arizona, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
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.
Time frame: from birth through the first 28 days of life
Gestational age of baby
gestational age of the baby on the day of it's birth
Time frame: measured within the first 24 hours following birth.
Baby's birth weight
weight of the baby taken with in the first hours following birth
Time frame: measured within the first 24 hours following birth
Intrauterine growth restriction (IUGR)
a measurement done by ultrasound taken at any time during the pregnancy prior to birth
Time frame: anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Baby's Head Circumference
a measurement of the baby's head taken within the first hours following birth
Time frame: measured within the first 24 hours following birth
Newborn Mechanical Ventilatory days
measurement of the total number of days the baby requires mechanical ventilatory support
Time frame: measured from birth to 28 days following birth
Newborn Oxygen support days
measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)
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Good Samaritan Hospital
San Jose, California, United States
Presbyterian/St Luke's Hospital
Denver, Colorado, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Lousiana State University Health Science
Shreveport, Louisiana, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States
Time frame: measured from birth to 28 days following birth
Newborn Surfactant therapy
measurement of the need for newborn surfactant therapy within the first 28 day following birth
Time frame: measured within the first 24 hours following birth
Newborn Hospital Days
the number of days that newborn remains in the hospital following its birth.
Time frame: measured within the first 24 hours following birth
Pneumothorax
diagnosis of a collapsed lung supported by clinical or radiologic evidence.
Time frame: measured within the first 24 hours following birth
Maternal Infectious Morbidity
diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.
Time frame: measured within the first 24 hours following birth
time from first dose of study drug to birth
the number of hours/days from the time of the first dose of study drug until birth
Time frame: measured in days/hours from the time of administration of first study drug until birth.