NCT01977040

Optimal Management of Vasa Previa Study - A Retrospective Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Obstetrix Medical Group · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vasa Previa

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-11-06
• Last updated: 2019-01-11
• Results posted: 2019-01-11

Locations

9 sites across 1 country: United States