Neonatal Outcome by Reason for Delivery

Completed

Conditions studied: Preterm Delivery

In brief

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.

Key facts

Study ID

NCT01818518

Run by

Obstetrix Medical Group

People needed

995

Starts

2013-07-01

Expected to finish

2016-07-25

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Banner Desert Medical Center — Mesa, Arizona, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Scottsdale Healthcare-Shea Medical Center — Scottsdale, Arizona, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Good Samaritan Hospital — San Jose, California, United States
• Presbyterian/St Luke's Hospital — Denver, Colorado, United States
• Saint Luke's Hospital, Kansas City — Kansas City, Missouri, United States
• Mercy Hospital of St. Louis — St Louis, Missouri, United States
• Harris Methodist Hospital - Fort Worth — Fort Worth, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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