Optimal Management of Vasa Previa Study - A Retrospective Study

Vasa Previa Clinical Trial

— VasaPrevia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977040
• Other study ID #: OBX0025
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2019
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Vasa Previa

Locations

Country	Name	City	State
United States	Presbyterian/St Luke's Hospital	Denver	Colorado
United States	Saint Luke's Hospital, Kansas City	Kansas City	Missouri
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Banner Desert Medical Center	Mesa	Arizona
United States	University of South Alabama Medical Center	Mobile	Alabama
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Good Samaritan Hospital	San Jose	California
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Obstetrix Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	Mode of Delivery Stratified by Diagnostic Profile.	Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile	At birth.
Primary	Gestational Age of Infant at Birth	Gestational age of the infant noted in weeks at the time of birth	At birth.