Optimal Management of Vasa Previa Study - A Retrospective Study (VasaPrevia)

January 10, 2019 updated by: Obstetrix Medical Group

Optimal Management of Vasa Previa: Screening, Diagnosis and Management - A Retrospective Study.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Medical Center
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Banner Desert Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Medical Center
    • California
      • Laguna Hills, California, United States, 92653
        • Saddleback Memorial Medical Center
      • Long Beach, California, United States, 90801-1428
        • Long Beach Memorial Medical Center
      • San Jose, California, United States, 95008
        • Good Samaritan Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Presbyterian/St Luke's Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital, Kansas City
    • Washington
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.
Time Frame: Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months
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.
Time Frame: Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery.
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.
Time Frame: At birth.
Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile
At birth.
Gestational Age of Infant at Birth
Time Frame: At birth.
Gestational age of the infant noted in weeks at the time of birth
At birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obstetrix Medical Group

Investigators

  • Principal Investigator: Thomas Garite, MD, Pediatrix Medical Group, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (ESTIMATE)

November 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBX0025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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