Premature Birth
Conditions
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.
Interventions
DRUGBetamethasone - ACTIVE
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
OTHERNormal Saline - PLACEBO
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
Sponsors
Pediatrix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Gestational age of baby | measured within the first 24 hours following birth. | gestational age of the baby on the day of it's 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. |
| 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 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 |
Countries
United States
Outcome results
None listed