Status:

COMPLETED

Neonatal Outcome by Reason for Delivery

Lead Sponsor:

Obstetrix Medical Group

Conditions:

Preterm Delivery

Eligibility:

FEMALE

18-65 years

Brief 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 defin...

Detailed 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 ...

Eligibility Criteria

Inclusion

  • Delivery at participating hospitals at less than 32weeks of gestation based on best obstetrical dating
  • Singleton pregnancy
  • Delivery where the baby is:
  • Stillborn OR
  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 25 2016

Estimated Enrollment :

995 Patients enrolled

Trial Details

Trial ID

NCT01818518

Start Date

July 1 2013

End Date

July 25 2016

Last Update

June 18 2019

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Banner Desert Medical Center

Mesa, Arizona, United States, 85210

2

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States, 85006

3

Scottsdale Healthcare-Shea Medical Center

Scottsdale, Arizona, United States, 85260

4

Saddleback Memorial Medical Center

Laguna Hills, California, United States, 92653