Overview

This trial is active, not recruiting.

Condition preterm delivery
Sponsor Obstetrix Medical Group
Start date July 2013
End date October 2016
Trial size 1290 participants
Trial identifier NCT01818518, OBX0022

Summary

To determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Group who goes into labor prior to 32 weeks of gestation
Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor.
Premature birth before 32 weeks gestation not including PTL or PROM

Primary Outcomes

Measure
Composite Perinatal Morbidity
time frame: From birth until neonatal hospital discharge (from birth + or minus 6 months)

Secondary Outcomes

Measure
Mortality and morbidity differences between groups
time frame: Birth until neonatal hospital discharge (from birth + or minus 6 months of age)

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating - Singleton pregnancy - Delivery where the baby is: 1. Stillborn OR 2. Born alive and: - expires before it leaves the delivery room OR - is cared for in the Neonatal Intensive Care Unit or an Intermediate Care Nursery Exclusion Criteria: - Patient less than 18 years of age - Pregnancies that had previously been multiple gestations but where one or more fetuses had died after 12weeks of gestation - Deliveries where the baby is born alive, does not expire in the delivery room but the baby does not get admitted to the NICU.

Additional Information

Official title Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study
Principal investigator Thomas Garite, MD
Description This is a prospective, observational study that will use information from the medical records of mothers and their newborns. This study seeks to determine the rate of Composite Neonatal Morbidity for very preterm babies delivered secondary to preterm labor (PTL) vs. prelabor rupture of membranes (PROM). Composite neonatal morbidity is defined as ≥ 1 of the following: Respiratory Distress Syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis, necrotizing enterocolitis (NEC), or perinatal death (stillbirth or death before neonatal hospital discharge. Secondary Objectives: 1) Difference in mortality between the PTL and PROM groups, composite morbidity differences for other reasons for premature delivery, and individual morbidities including IVH, PVL, RDS, sepsis, seizures, BPD and NEC Study Population: All babies from singleton pregnancies delivering in each of the involved hospitals who deliver at less than 32 weeks of gestation who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included. Planned Sample Size: We plan a two year study and estimate based on historical data for the institutions to be included in the study, which should yield approximately 6000 babies less than (<) 32w0d gestation. For a 10% difference in composite morbidity (assuming 90% power and two-sided alpha=0.05) assuming a rate of 60% at least 661 patients are needed in each of the 3 groups (PTL, PROM, and other).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mednax Center for Research, Education and Quality.