CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 995 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01818518
NCT01818518N/ACompleted

Neonatal Outcome by Reason for Delivery - A Prospective, Observational Study

Obstetrix Medical Group·observational·Posted Mar 26, 2013·Updated Jun 18, 2019

In Brief

An observational study for Preterm Delivery. Completed, enrolled 995 participants across 10 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2013
Enrollment StartJul 1, 2013
Primary CompletionMay 3, 2016
Study CompletionJul 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.3 years ago