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Neonatal Outcome by Reason for Delivery

NCT01818518 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 995

Last updated 2019-06-18

Study results available
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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.

Conditions

  • Preterm Delivery

Sponsors & Collaborators

  • Obstetrix Medical Group

    lead INDUSTRY

Principal Investigators

  • Thomas Garite, MD · Obstetrix Medical Group

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-05-03
Completion
2016-07-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818518 on ClinicalTrials.gov