Clinical trial NCT01977040: Optimal Management of Vasa Previa Study - A Retrospective Study
Official title: Optimal Management of Vasa Previa: Screening, Diagnosis and Management - A Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vasa Previa
Keywords: Vasa Previa
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 68
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.
timeFrame: Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months
measure: Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile.
timeFrame: Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery.
measure: Mode of Delivery Stratified by Diagnostic Profile.
timeFrame: At birth.
measure: Gestational Age of Infant at Birth
timeFrame: At birth.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Mesa
country: United States
facility: Banner Desert Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: Laguna Hills
country: United States
facility: Saddleback Memorial Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Presbyterian/St Luke's Hospital
state: Colorado
city: Kansas City
country: United States
facility: Saint Luke's Hospital, Kansas City
state: Missouri
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Pediatrix Medical Group, Inc.
name: Thomas Garite, MD
role: PRINCIPAL_INVESTIGATOR
References: