3D Ultrasound in Women With Vacuum or Forceps Deliveries

Completed

• Conditions: Pelvic Floor Injury; Urinary Incontinence; Stool Incontinence

• Registration Number: NCT01680731
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-19
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levator ani injury on 3D ultrasound	1-5 years after delivery	Assessment of levator ani injury on trasnperineal 3D ultrasound images

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States