NCT01680731|Completed
3D Ultrasound in Women With Vacuum or Forceps Deliveries
VADUS
3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries
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VADUS
3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries
Sponsor study identifier
observational
45
1 country
1
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women within 1-5 years after first delivery who did not have an internal delivery will be included. The total number of subjects is forty. This will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 4, 2012
Actual (reported)September 7, 2012
Actual (reported)April 2013
Actual (reported)April 2013
Actual (reported)Levator ani injury on 3D ultrasound
Assessment of levator ani injury on trasnperineal 3D ultrasound images
1-5 years after delivery
Forceps assisted vaginal delivery within 1-5 years without any interval delivery
Vacuum assisted vaginal delivery within 1-5 years without any interval delivery
Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor
Spontaneous vaginal delivery within 1-5 years without any interval delivery
Forty primiparous subjects with a history of a singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery with 10 subjects in each group.
University of Rochester
Rochester, New York, 14642, United States
Tulin Ozcan, MD
University of Rochester
45 participants (actual enrollment reported by the registry).
First Submitted
September 4, 2012
First Posted
September 7, 2012
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Translating Unique Learning for Incontinence Prevention
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads
Contact the study team to confirm eligibility.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
February 21, 2014
Record last verified: 2014-02
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Source: ClinicalTrials.gov.
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