VasaPrevia: Optimal Management of Vasa Previa Study - A Retrospective Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. [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.
- 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. [At birth.]
Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile
- Gestational Age of Infant at Birth [At birth.]
Gestational age of the infant noted in weeks at the time of birth
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama Medical Center | Mobile | Alabama | United States | 36617 |
| 2 | Banner Desert Medical Center | Mesa | Arizona | United States | 85210 |
| 3 | Banner Good Samaritan Medical Center | Phoenix | Arizona | United States | 85006 |
| 4 | Saddleback Memorial Medical Center | Laguna Hills | California | United States | 92653 |
| 5 | Long Beach Memorial Medical Center | Long Beach | California | United States | 90801-1428 |
| 6 | Good Samaritan Hospital | San Jose | California | United States | 95008 |
| 7 | Presbyterian/St Luke's Hospital | Denver | Colorado | United States | 80218 |
| 8 | Saint Luke's Hospital, Kansas City | Kansas City | Missouri | United States | 64111 |
| 9 | Swedish Medical Center | Seattle | Washington | United States | 98122-4307 |
Sponsors and Collaborators
- Obstetrix Medical Group
Investigators
- Principal Investigator: Thomas Garite, MD, Pediatrix Medical Group, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OBX0025
Study Results
Participant Flow
| Recruitment Details | 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 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vasa Previa |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 68 |
| COMPLETED | 66 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Vasa Previa |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 68 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
68
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
68
100%
|
| Male |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
68
100%
|
Outcome Measures
| Title | Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. |
|---|---|
| Description | 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. |
| Time Frame | Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vasa Previa |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 66 |
| Antepartum Ultrasound, confirmed at delivery |
47
69.1%
|
| Antepartum Ultrasound, not confirmed at delivery |
13
19.1%
|
| Antepartum Ultrasound, resolved prior to delivery |
4
5.9%
|
| No antepartum diagnosis, Vasa Previa at birth |
2
2.9%
|
| Title | Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. |
|---|---|
| Description | |
| Time Frame | Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 64 participants had vasa previa diagnosed via ultrasound during the antenatal period. |
| Arm/Group Title | Vasa Previa |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 64 |
| Antepartum Ultrasound, confirmed at delivery |
27.0
|
| Antepartum Ultrasound, not confirmed at delivery |
27.8
|
| Antepartum Ultrasound, resolved prior to delivery |
19.8
|
| Title | Mode of Delivery Stratified by Diagnostic Profile. |
|---|---|
| Description | Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile |
| Time Frame | At birth. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Emergent Cesarean Section | Non-Emergent Cesarean Section | Vaginal Delivery |
|---|---|---|---|
| Arm/Group Description | Cesarean Section prompted by a medical emergency. | Cesarean Section planned or non-emergency related. | Delivered vaginally. |
| Measure Participants | 10 | 51 | 5 |
| Antepartum Ultrasound, confirmed at delivery |
7
10.3%
|
40
NaN
|
2
NaN
|
| Antepartum Ultrasound, not confirmed at delivery |
2
2.9%
|
9
NaN
|
2
NaN
|
| Antepartum Ultrasound, resolved prior to delivery |
0
0%
|
1
NaN
|
1
NaN
|
| No antepartum diagnosis, Vasa Previa at birth |
1
1.5%
|
1
NaN
|
0
NaN
|
| Title | Gestational Age of Infant at Birth |
|---|---|
| Description | Gestational age of the infant noted in weeks at the time of birth |
| Time Frame | At birth. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Mean Gestational age at delivery as well as Mean Gestational Age for those patients who delivered emergently and non-emergent are presented. |
| Arm/Group Title | Emergent Cesarean Section | Non-Emergent Cesarean Section and Vaginal Delivery |
|---|---|---|
| Arm/Group Description | Cesarean Section prompted by a medical emergency. | Cesarean Section planned or non-emergency related and Vaginal Deliveries were included in this data |
| Measure Participants | 10 | 56 |
| Antepartum Ultrasound, confirmed at delivery |
34.76
(1.24)
|
34.68
(1.84)
|
| Antepartum Ultrasound, not confirmed at delivery |
31.50
(2.73)
|
34.78
(1.47)
|
| Antepartum Ultrasound, resolved prior to delivery |
37.04
(1.55)
|
|
| No antepartum diagnosis, Vasa Previa at birth |
36.14
(1)
|
35.57
(0.4)
|
Adverse Events
| Time Frame | Not applicable to this retrospective study. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed | |
|---|---|---|
| Adverse Event Reporting Description | Not applicable to this retrospective study. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed | |
| Arm/Group Title | Vasa Previa | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Vasa Previa | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Serious Adverse Events |
||
| Vasa Previa | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Vasa Previa | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Kimberly Maurel |
|---|---|
| Organization | Mednax. Inc |
| Phone | 714593-9171 |
| kimberly_maurel@mednax.com |
- OBX0025