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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasa Previa | Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. | |
| Mode of Delivery Stratified by Diagnostic Profile. | Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile | At birth. |
| Gestational Age of Infant at Birth | Gestational age of the infant noted in weeks at the time of birth | At birth. |
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Inclusion Criteria:
Exclusion Criteria:
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Women at participating site who have been identified as having a vasa previa between January 1, 2000 and December 31, 2012.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Garite, MD | Pediatrix Medical Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States | ||
| Banner Desert Medical Center |
undecided
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In a retrospective manner, we recruited all pregnancies complicated by vasa previa that delivery between January 1, 2000 and December 31, 2012 at nine Maternal Fetal Medicine Practices. The diagnosis of vasa previa was made either during the antenatal period by an ultrasound or at the time of delivery via clinical and/or pathologic investigation
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| ID | Title | Description |
|---|---|---|
| FG000 | Vasa Previa | Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vasa Previa | Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months |
|
Not applicable to this retrospective study. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
Not applicable to this retrospective study. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vasa Previa | Women with the diagnosis of Vasa Previa made during the pregnancy or at time of delivery who delivered between January 1, 2000 and December 31, 2012. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Maurel | Mednax. Inc | 714593-9171 | kimberly_maurel@mednax.com |
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| ID | Term |
|---|---|
| D055949 | Vasa Previa |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Mesa |
| Arizona |
| 85210 |
| United States |
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | United States |
| Saddleback Memorial Medical Center | Laguna Hills | California | 92653 | United States |
| Long Beach Memorial Medical Center | Long Beach | California | 90801-1428 | United States |
| Good Samaritan Hospital | San Jose | California | 95008 | United States |
| Presbyterian/St Luke's Hospital | Denver | Colorado | 80218 | United States |
| Saint Luke's Hospital, Kansas City | Kansas City | Missouri | 64111 | United States |
| Swedish Medical Center | Seattle | Washington | 98122-4307 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Enrolled in the US mostly western United States | Number | participants |
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| Primary | Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. | Only 64 participants had vasa previa diagnosed via ultrasound during the antenatal period. | Posted | Mean | Full Range | weeks | Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery. |
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| Primary | Mode of Delivery Stratified by Diagnostic Profile. | Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile | Posted | Count of Participants | Participants | At birth. |
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| Primary | Gestational Age of Infant at Birth | Gestational age of the infant noted in weeks at the time of birth | Mean Gestational age at delivery as well as Mean Gestational Age for those patients who delivered emergently and non-emergent are presented. | Posted | Mean | Standard Deviation | weeks | At birth. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| Antepartum Ultrasound, resolved prior to delivery |
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| Antepartum Ultrasound, resolved prior to delivery |
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| No antepartum diagnosis, Vasa Previa at birth |
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| Antepartum Ultrasound, not confirmed at delivery |
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| Antepartum Ultrasound, resolved prior to delivery |
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| No antepartum diagnosis, Vasa Previa at birth |
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