Neonatal Outcome by Reason for Delivery

Preterm Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818518
• Other study ID #: OBX0022
• Status: Completed
• Start date: July 2013
• Est. completion date: July 25, 2016

Study information

• Verified date: June 2019
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 995
• Est. completion date: July 25, 2016
• Est. primary completion date: May 3, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Perinatal Morbidity	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).	Infants from birth until discharge or until infant reaches 28 days of life.