Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
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|ClinicalTrials.gov Identifier: NCT02939742|
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : January 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|PPROM Respiratory Distress Syndrome in Premature Infants||Drug: Betamethasone Drug: Placebo||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2023|
Women admitted with PPROM who will receive a second course of two betamethasone 12mg intramuscular (IM) injections given 24 hours apart.
Betamethasone 12mg IM given every 24 hours for two doses
Other Name: Celestone
Placebo Comparator: Saline Placebo
Women admitted with PPROM who will receive intramuscular saline placebo, given as two injections 24 hours apart.
Sterile 0.9% normal saline solution given IM every 24 hours for two doses
Other Name: Saline placebo
- Length of stay in the neonatal intensive care unit (NICU) [ Time Frame: daily from birth of infant up to one year ]expressed in days
- Composite neonatal morbidity [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]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)
- Duration of oxygen and ventilatory support [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]Amount of time in days from birth that the infant requires supplemental oxygen of any form, including nasal cannula, positive airway pressure, or ventilatory support
- Development of Respiratory Distress Syndrome (RDS) [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]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
- Grade III or IV intraventricular hemorrhage (IVH) [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]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.
- Neonatal Sepsis [ Time Frame: daily up to 72 hours of life ]confirmed by culture in the first 72 hours of life
- Necrotizing enterocolitis (NEC) stage 2 or 3 [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]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.
- Perinatal death [ Time Frame: assessed daily up to 120 days after birth or discharge from hospital, whichever occurs first ]defined as stillbirth or death before neonatal discharge
- Labor latency [ Time Frame: time from admission to delivery up to one year, or through study completion ]time from diagnosis of PPROM from admission until delivery of neonate or until completion of the study
- Infectious morbidities [ Time Frame: time from admission until maternal discharge from the hospital and up until 6 weeks postpartum, or through study completion ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939742
|Contact: Mauricio La Rosa De Los Rios, MD||409-772-1571||malarosa@UTMB.EDU|
|Contact: Maggie j Kuhlmann-Capek, MD||409-772-1571||makuhlma@UTMB.EDU|
|United States, Texas|
|University of Texas Medical Branch in Galveston||Recruiting|
|Galveston, Texas, United States, 77555|
|Contact: Mauricio La Rosa De Los Rios, MD 409-772-1571 malarosa@UTMB.EDU|
|Contact: Ester Godbold, RN 409-772-0991 email@example.com|
|Principal Investigator: Maged M Costantine, MD|
|Sub-Investigator: Mauricio La Rosa De Los Rios, MD|
|Sub-Investigator: Gayle L Olson-Koutrouvelis, MD|
|Sub-Investigator: Maggie J Kuhlmann-Capek, MD|
|Principal Investigator:||Maged M Costantine, MD||University of Texas Medical Branch in Galveston|