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Clinical Trials/NCT01680731
NCT01680731
Completed
Not Applicable

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

University of Rochester1 site in 1 country45 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Injury
Sponsor
University of Rochester
Enrollment
45
Locations
1
Primary Endpoint
Levator ani injury on 3D ultrasound
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
April 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tulin Ozcan MD

Associate Professor of Obstetrics and Gynecology

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Females age \>18 and \<
  • 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).

Outcomes

Primary Outcomes

Levator ani injury on 3D ultrasound

Time Frame: 1-5 years after delivery

Assessment of levator ani injury on trasnperineal 3D ultrasound images

Study Sites (1)

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