Neonatal Outcome by Reason for Delivery

NCT01818518 | Completed Results

• 1 other identifier: OBX0022
• Study Type: observational
• Target: 995
• Locations: 1 country
• Sites: 10

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.

Conditions

Preterm Delivery

Keywords

Preterm delivery; Premature delivery; Premature birth

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Preterm Labor

Group who goes into labor prior to 32 weeks of gestation

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.

Premature birth before 32 weeks gestation

Premature birth before 32 weeks gestation not including PTL or PROM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All babies from singleton pregnancies delivering in each of the involved hospitals who delivered at less than 32 weeks of gestation and who are stillborn, who die in the delivery room and who are cared for in the Neonatal Intensive Care Unit (NICU) will be included.

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.

Sponsors & Collaborators

• Obstetrix Medical Group: lead

Study Sites (10)

Banner Desert Medical Center

Mesa, Arizona, 85210, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Scottsdale Healthcare-Shea Medical Center

Scottsdale, Arizona, 85260, United States

Location

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

Location

Good Samaritan Hospital

San Jose, California, 95008, United States

Location

Presbyterian/St Luke's Hospital

Denver, Colorado, 80218, United States

Location

Saint Luke's Hospital, Kansas City

Kansas City, Missouri, 64111, United States

Location

Mercy Hospital of St. Louis

St Louis, Missouri, 63141, United States

Location

Harris Methodist Hospital - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Kimberly Maurel
• Organization: Mednax. Inc

kimberly_maurel@mednax.com

714-593-9171

Study Officials

• Thomas Garite, MD

  Obstetrix Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: July 1, 2013
• Primary Completion: May 3, 2016
• Study Completion: July 25, 2016
• Last Updated: June 18, 2019
• Results First Posted: June 7, 2019

Record last verified: 2019-06

Locations

US (10)