Neonatal Outcome by Reason for Delivery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

995 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-07-25

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Preterm Delivery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Labor

Group who goes into labor prior to 32 weeks of gestation

No interventions assigned to this group

Prelabor rupture of membranes

Group who have prelabor rupture of membranes are those who break their bag of water prior to 32 weeks gestation in the absence of labor.

No interventions assigned to this group

Premature birth before 32 weeks gestation

Premature birth before 32 weeks gestation not including PTL or PROM

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes