Optimal Management of Vasa Previa Study - A Retrospective Study

NCT01977040 | Completed Results

• 1 other identifier: OBX0025
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Vasa Previa

Keywords

Vasa Previa

Outcome Measures

Primary Outcomes (4)

• Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.

  The primary outcome of the study it to describe antenatal techniques utilized to screen for and diagnose vasa previa. Vasa previa is when unprotected blood vessels implanted in the membranes or sac run from the placenta across the inside of the woman's cervix. Antepartum ultrasounds were conducted according to standard of care. Here we report the count of participants who were diagnosed during routine ultrasound exam. After initial diagnosis by ultrasound, Vasa Previa's were followed up by routine ultrasounds for confirmation prior to delivery.

  Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months

• Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile.

  Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery.

• Mode of Delivery Stratified by Diagnostic Profile.

  Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile

  At birth.

• Gestational Age of Infant at Birth

  Gestational age of the infant noted in weeks at the time of birth

  At birth.

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women at participating site who have been identified as having a vasa previa between January 1, 2000 and December 31, 2012.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Obstetrix Medical Group: lead

Study Sites (9)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

Location

Banner Desert Medical Center

Mesa, Arizona, 85210, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Saddleback Memorial Medical Center

Laguna Hills, California, 92653, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90801-1428, 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

Swedish Medical Center

Seattle, Washington, 98122-4307, United States

Location

MeSH Terms

Conditions

Vasa Previa

Condition Hierarchy (Ancestors)

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

714593-9171

Study Officials

• Thomas Garite, MD

  Pediatrix Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: November 6, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 11, 2019
• Results First Posted: January 11, 2019

Record last verified: 2019-01

Locations

US (9)