Optimal Management of Vasa Previa: Screening, Diagnosis and Management - A Retrospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 9
- 主要终点
- Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •No diagnosis or confirmation of vasa previa
- •Delivered either before January 1, 2000 or after December 31, 2012
结局指标
主要结局
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.
时间窗: 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.
Mode of Delivery Stratified by Diagnostic Profile.
时间窗: At birth.
Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile
Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile.
时间窗: Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery.
Gestational Age of Infant at Birth
时间窗: At birth.
Gestational age of the infant noted in weeks at the time of birth
次要结局
未报告次要终点