Neonatal Outcome by Reason for Delivery

Completed

• Conditions: Preterm Delivery

• Registration Number: NCT01818518
• Lead Sponsor: Obstetrix Medical Group

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 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.

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 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).

Study Timeline

• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Study Start: 2013-07
• Primary Completion: 2016-05-03
• Study Completion: 2016-07-25
• Results First Submitted: 2018-05-07
• Results First Submitted QC: 2019-03-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Results First Posted: 2019-06-07
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 995

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Perinatal Morbidity	Infants from birth until discharge or until infant reaches 28 days of life.	The primary outcome is Composite Perinatal Morbidity. Composite morbidity refers to the newborns born to the female participants enrolled in the study. Composite 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 present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge).

Trial Locations

Locations (10)

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; 🇺🇸 Saint Louis, Missouri, United States

Harris Methodist Hospital - Fort Worth; 🇺🇸 Fort Worth, Texas, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States