Optimal Management of Vasa Previa Study - 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.

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Key information

Conditions

Vasa Previa Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of South Alabama Medical Center, Mobile, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.
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.
Mode of Delivery Stratified by Diagnostic Profile.

Time frame: At birth.

Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile
Gestational Age of Infant at Birth

Time frame: At birth.

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

Sponsors and collaborators

Lead sponsor

Obstetrix Medical Group

Industry

Registry information

Official study title

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

Acronym: VasaPrevia

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 6, 2013
Registry last updated: Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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