Vasa PreviaVasaPreviaNCT01977040
Optimal Management of Vasa Previa Study - A Retrospective Study
An observational study of Vasa Previa, run by Obstetrix Medical Group at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasa Previa
- How many people
- 68 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2014to Jan 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women at participating site who have been identified as having a vasa previa between January 1, 2000 and December 31, 2012.
Who may be able to join
- 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
Who cannot join
- No diagnosis or confirmation of vasa previa
- Delivered either before January 1, 2000 or after December 31, 2012
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
Saint Luke's Hospital, Kansas City
Kansas City, Missouri, 64111
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428
Banner Desert Medical Center
Mesa, Arizona, 85210
University of South Alabama Medical Center
Mobile, Alabama, 36617
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Good Samaritan Hospital
San Jose, California, 95008
Swedish Medical Center
Seattle, Washington, 98122-4307
About this study
Official title: Optimal Management of Vasa Previa: Screening, Diagnosis and Management - A Retrospective Study.
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.
Read the 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
- Keywords
- Vasa Previa
- Medical subject headings
- Vasa Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: At birth.
Gestational Age of Infant at Birth
Gestational age of the infant noted in weeks at the time of birth
Measured: At birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasa PreviaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Garite, MD, Principal investigator, Pediatrix Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977040
- Sponsor's protocol ID
- OBX0025
- Acronym
- VasaPrevia
- Status last verified
- Jan 2019
- First submitted
- 4 Oct 2013
- Last updated
- 11 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Management of Vasa Previa: Screening, Diagnosis and Management - A Retrospective Study.
- ClinicalTrials.gov ID
- NCT01977040
- Acronym / sponsor ID
- VasaPrevia / OBX0025
- Conditions
- Vasa Previa
- Keywords
- Vasa Previa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 11 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women at participating site who have been identified as having a vasa previa between January 1, 2000 and December 31, 2012.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- No diagnosis or confirmation of vasa previa
- Delivered either before January 1, 2000 or after December 31, 2012
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.
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
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.
Time frame: 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.
Time frame: At birth.
Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile
Gestational Age of Infant at Birth
Time frame: At birth.
Gestational age of the infant noted in weeks at the time of birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Vasa Previa
RecruitingObservational study
Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome
Fetal Growth Restriction (FGR), Preeclampsia
Recruiting
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Fetal Conditions, Maternal; Procedure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Garite, MD principal investigator
Pediatrix Medical Group, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasa Previa, run by Obstetrix Medical Group at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.