Trial Outcomes & Findings for Optimal Management of Vasa Previa Study - A Retrospective Study (NCT NCT01977040)

NCT ID: NCT01977040

Last Updated: 2019-01-11

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 68 participants
• Primary outcome timeframe: Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months
• Results posted on: 2019-01-11

Participant Flow

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

Participant milestones

Measure	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.
Overall Study STARTED	68
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Vasa previa not confirmed	2

Baseline Characteristics

Optimal Management of Vasa Previa Study - A Retrospective Study

Baseline characteristics by cohort

Measure	Vasa Previa n=68 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Vasa Previa n=66 Participants 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.	Non-Emergent Cesarean Section Cesarean Section planned or non-emergency related.	Vaginal Delivery Delivered vaginally.
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. Antepartum Ultrasound, confirmed at delivery	47 Participants	—	—
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. Antepartum Ultrasound, not confirmed at delivery	13 Participants	—	—
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. Antepartum Ultrasound, resolved prior to delivery	4 Participants	—	—
Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy. No antepartum diagnosis, Vasa Previa at birth	2 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Vasa Previa n=64 Participants 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.	Non-Emergent Cesarean Section Cesarean Section planned or non-emergency related.	Vaginal Delivery Delivered vaginally.
Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. Antepartum Ultrasound, confirmed at delivery	27.0 weeks Interval 16.0 to 40.0	—	—
Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. Antepartum Ultrasound, not confirmed at delivery	27.8 weeks Interval 16.0 to 32.0	—	—
Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile. Antepartum Ultrasound, resolved prior to delivery	19.8 weeks Interval 18.0 to 21.0	—	—

PRIMARY outcome

Timeframe: At birth.

Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile

Outcome measures

Measure	Vasa Previa n=10 Participants 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.	Non-Emergent Cesarean Section n=51 Participants Cesarean Section planned or non-emergency related.	Vaginal Delivery n=5 Participants Delivered vaginally.
Mode of Delivery Stratified by Diagnostic Profile. Antepartum Ultrasound, not confirmed at delivery	2 Participants	9 Participants	2 Participants
Mode of Delivery Stratified by Diagnostic Profile. Antepartum Ultrasound, resolved prior to delivery	0 Participants	1 Participants	1 Participants
Mode of Delivery Stratified by Diagnostic Profile. Antepartum Ultrasound, confirmed at delivery	7 Participants	40 Participants	2 Participants
Mode of Delivery Stratified by Diagnostic Profile. No antepartum diagnosis, Vasa Previa at birth	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Gestational age of the infant noted in weeks at the time of birth

Outcome measures

Measure	Vasa Previa n=10 Participants 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.	Non-Emergent Cesarean Section n=56 Participants Cesarean Section planned or non-emergency related.	Vaginal Delivery Delivered vaginally.
Gestational Age of Infant at Birth Antepartum Ultrasound, confirmed at delivery	34.76 weeks Standard Deviation 1.24	34.68 weeks Standard Deviation 1.84	—
Gestational Age of Infant at Birth Antepartum Ultrasound, not confirmed at delivery	31.50 weeks Standard Deviation 2.73	34.78 weeks Standard Deviation 1.47	—
Gestational Age of Infant at Birth Antepartum Ultrasound, resolved prior to delivery	—	37.04 weeks Standard Deviation 1.55	—
Gestational Age of Infant at Birth No antepartum diagnosis, Vasa Previa at birth	36.14 weeks Standard Deviation 1	35.57 weeks Standard Deviation 0.4	—

Adverse Events

Vasa Previa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kimberly Maurel

Mednax. Inc

Phone: 714593-9171

Email: kimberly_maurel@mednax.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place