Optimal Management of Vasa Previa Study - A Retrospective Study

NCT ID: NCT01977040

Last Updated: 2019-01-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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This is a multicenter retrospective observational study of women diagnosed with a vasa previa during pregnancy or at delivery who delivered between 2000 and 2012. The study hopes to be able to describe techniques utilized to screen for and diagnose vasa previa as well as to describe the maternal characteristics and identify potential underlying risk factors that may provide a basis for future screening recommendations for vasa previa and treatment protocols.

Detailed Description

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This is a multicenter retrospective study of women identified as having a vasa previa during pregnancy or at the time of delivery who delivered between January 1, 2000 and December 31, 2012 at participating centers. The primary objective of the study is to describe techniques utilized to screen for and diagnose vasa previa.

* In those cases that were diagnosed antenatally, to describe the different management protocols utilized, correlate these management protocols with neonatal outcomes and support the management protocol that offers optimal outcomes for both mother and neonate.
* In those cases that were not diagnosed antenatally, to describe the clinical scenario surrounding delivery and the neonatal outcomes. Review the ultrasound reports and maternal characteristics to identify any potential risk factors for vasa previa that could have been identified antenatally in attempt to improve neonatal outcomes in the future.
* In all cases of diagnosed vasa previa (those diagnosed antepartum, intrapartum, and postpartum), to describe the maternal characteristics and identify potential underlying risk factors that may provide a basis for future screening recommendations and protocols. Due to the rarity of this diagnosis, the study hopes to include 100-250 participants.

Conditions

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Vasa Previa

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Vasa Previa

Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with the diagnosed of vasa previa made either during the pregnancy via ultrasound or at time of delivery via clinical and/or pathologic investigation.
* Patient delivered between January 2000 through December 2012

Exclusion Criteria

* No diagnosis or confirmation of vasa previa
* Delivered either before January 1, 2000 or after December 31, 2012
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Obstetrix Medical Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Garite, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrix Medical Group, Inc.

Locations

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University of South Alabama Medical Center

Mobile, Alabama, United States

Site Status

Banner Desert Medical Center

Mesa, Arizona, United States

Site Status

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Site Status

Saddleback Memorial Medical Center

Laguna Hills, California, United States

Site Status

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

Good Samaritan Hospital

San Jose, California, United States

Site Status

Presbyterian/St Luke's Hospital

Denver, Colorado, United States

Site Status

Saint Luke's Hospital, Kansas City

Kansas City, Missouri, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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OBX0025

Identifier Type: -

Identifier Source: org_study_id

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