Trial Outcomes & Findings for Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity? (NCT NCT02939742)

Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?

Mean number of days participants remained admitted to the Neonatal Intensive Care Unit (NICU) during hospitalization following birth.

defined as ≥ 1 of the following: RDS (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen support at 30 days of life), severe IVH (grades III or IV), periventricular leukomalacia, blood culture-proven sepsis, necrotizing enterocolitis, or perinatal death (stillbirth or death before neonatal hospital discharge)

Amount of time, expressed in days from birth, that the infant required supplemental oxygen of any form, including nasal cannula, positive airway pressure, or ventilatory support. Reported as the mean number of days participants required supplemental oxygen therapy or ventilatory support.

Will be quantified as either present or absent. RDS defined as: compatible symptoms with radiographic evidence of hyaline membrane disease or respiratory insufficiency of prematurity requiring ventilatory support for ≥ 24 hrs

Will be quantified as either present or absent. Grade III IVH defined as ventricles enlarged by accumulating blood. Grade IV IVH defined as bleeding extending into brain matter around the ventricles.

confirmed by culture in the first 72 hours of life

Will be quantified as either present or absent. Stage 2 NEC will be defined as mild to moderate systemic illness, absent bowel sounds, abdominal tenderness, pneumatosis intestinalis or portal venous gas, metabolic acidosis, decreased platelets. Stage 3 NEC will be defined as severely ill, marked distention, signs of peritonitis, hypotension, metabolic \& respiratory acidosis, disseminated intravascular coagulopathy, pneumoperitoneum if bowel perforation present.

defined as stillbirth or death before neonatal discharge

time from diagnosis of PPROM from admission until delivery of neonate or until completion of the study

Chorioamnionitis will be defined as at least one temperature elevation above 38°C combined with at least two of the following signs: maternal or fetal tachycardia, uterine tenderness, foul smelling vaginal discharge, white blood count \> 18,000. Postpartum endometritis will be defined as postpartum temperature elevation above 38°C without other localizing sources of infection and with either uterine tenderness or foul-smelling lochia.