Vasa Previa
Conditions
Keywords
Vasa Previa
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.
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.
Interventions
None listed
Sponsors
Obstetrix Medical Group
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 68 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Vasa previa not confirmed | 2 |
Baseline characteristics
| Characteristic | Vasa Previa |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Region of Enrollment United States | 68 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vasa Previa | Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. | No antepartum diagnosis, Vasa Previa at birth | 2 Participants |
| Vasa Previa | Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. | Antepartum Ultrasound, confirmed at delivery | 47 Participants |
| Vasa Previa | Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. | Antepartum Ultrasound, not confirmed at delivery | 13 Participants |
| Vasa Previa | Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. | Antepartum Ultrasound, resolved prior to delivery | 4 Participants |
Primary
Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile.
Time frame: Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery.
Population: Only 64 participants had vasa previa diagnosed via ultrasound during the antenatal period.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Vasa Previa | Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. | Antepartum Ultrasound, confirmed at delivery | 27.0 weeks |
| Vasa Previa | Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. | Antepartum Ultrasound, not confirmed at delivery | 27.8 weeks |
| Vasa Previa | Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. | Antepartum Ultrasound, resolved prior to delivery | 19.8 weeks |
Primary
Gestational Age of Infant at Birth
Gestational age of the infant noted in weeks at the time of birth
Time frame: At birth.
Population: Mean Gestational age at delivery as well as Mean Gestational Age for those patients who delivered emergently and non-emergent are presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vasa Previa | Gestational Age of Infant at Birth | Antepartum Ultrasound, not confirmed at delivery | 31.50 weeks | Standard Deviation 2.73 |
| Vasa Previa | Gestational Age of Infant at Birth | No antepartum diagnosis, Vasa Previa at birth | 36.14 weeks | Standard Deviation 1 |
| Vasa Previa | Gestational Age of Infant at Birth | Antepartum Ultrasound, confirmed at delivery | 34.76 weeks | Standard Deviation 1.24 |
| Non-Emergent Cesarean Section | Gestational Age of Infant at Birth | No antepartum diagnosis, Vasa Previa at birth | 35.57 weeks | Standard Deviation 0.4 |
| Non-Emergent Cesarean Section | Gestational Age of Infant at Birth | Antepartum Ultrasound, not confirmed at delivery | 34.78 weeks | Standard Deviation 1.47 |
| Non-Emergent Cesarean Section | Gestational Age of Infant at Birth | Antepartum Ultrasound, confirmed at delivery | 34.68 weeks | Standard Deviation 1.84 |
| Non-Emergent Cesarean Section | Gestational Age of Infant at Birth | Antepartum Ultrasound, resolved prior to delivery | 37.04 weeks | Standard Deviation 1.55 |
Primary
Mode of Delivery Stratified by Diagnostic Profile.
Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile
Time frame: At birth.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vasa Previa | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, confirmed at delivery | 7 Participants |
| Vasa Previa | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, not confirmed at delivery | 2 Participants |
| Vasa Previa | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, resolved prior to delivery | 0 Participants |
| Vasa Previa | Mode of Delivery Stratified by Diagnostic Profile. | No antepartum diagnosis, Vasa Previa at birth | 1 Participants |
| Non-Emergent Cesarean Section | Mode of Delivery Stratified by Diagnostic Profile. | No antepartum diagnosis, Vasa Previa at birth | 1 Participants |
| Non-Emergent Cesarean Section | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, confirmed at delivery | 40 Participants |
| Non-Emergent Cesarean Section | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, resolved prior to delivery | 1 Participants |
| Non-Emergent Cesarean Section | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, not confirmed at delivery | 9 Participants |
| Vaginal Delivery | Mode of Delivery Stratified by Diagnostic Profile. | No antepartum diagnosis, Vasa Previa at birth | 0 Participants |
| Vaginal Delivery | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, not confirmed at delivery | 2 Participants |
| Vaginal Delivery | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, resolved prior to delivery | 1 Participants |
| Vaginal Delivery | Mode of Delivery Stratified by Diagnostic Profile. | Antepartum Ultrasound, confirmed at delivery | 2 Participants |