VADUS: 3D Ultrasound in Women With Vacuum or Forceps Deliveries

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT01680731

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Injury Urinary Incontinence Stool Incontinence

Study Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Forceps assisted vaginal delivery Forceps assisted vaginal delivery within 1-5 years without any interval delivery
Vacuum assisted vaginal delivery Vacuum assisted vaginal delivery within 1-5 years without any interval delivery
Elective cesarean delivery Elective cesarean vaginal delivery within 1-5 years without any interval delivery done prior to labor
Spontaneous vaginal delivery Spontaneous vaginal delivery within 1-5 years without any interval delivery

Outcome Measures

Primary Outcome Measures

Levator ani injury on 3D ultrasound [1-5 years after delivery]
Assessment of levator ani injury on trasnperineal 3D ultrasound images

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator: Tulin Ozcan, MD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tulin Ozcan MD, Associate Professor of Obstetrics and Gynecology, University of Rochester

ClinicalTrials.gov Identifier:

NCT01680731

Other Study ID Numbers:

39146

First Posted:

Sep 7, 2012

Last Update Posted:

Feb 21, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Tulin Ozcan MD, Associate Professor of Obstetrics and Gynecology, University of Rochester

Pelvic floor injury

Levator ani muscle

Additional relevant MeSH terms:

Urinary Incontinence

Study Results

No Results Posted as of Feb 21, 2014