3D Ultrasound in Women With Vacuum or Forceps Deliveries

Urinary Incontinence Clinical Trial

— VADUS  

Official title:

3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680731
• Other study ID #: 39146
• Status: Completed
• Phase: N/A
• First received: September 4, 2012
• Last updated: February 19, 2014
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Females age >18 and <45.

• Primiparous females with 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.

• Birth weight >2500g and <4500g.

• Delivery should have occurred more than one year ago, but less than five years ago.

Pregestational BMI <35kg40kg/m2.

Exclusion Criteria:

• Presence of interim delivery.

• Presence of both vacuum and forceps use during delivery.

• Presence of pregestational or A2 gestational diabetes mellitus.

• Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis, Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fecal Incontinence
• Pelvic Floor Injury
• Stool Incontinence
• Urinary Incontinence

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levator ani injury on 3D ultrasound	Assessment of levator ani injury on trasnperineal 3D ultrasound images	1-5 years after delivery	No