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3D Ultrasound in Women With Vacuum or Forceps Deliveries (VADUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01680731
Recruitment Status : Completed
First Posted : September 7, 2012
Last Update Posted : February 21, 2014
Sponsor:
Information provided by (Responsible Party):

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
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 : October 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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 :
  1. Levator ani injury on 3D ultrasound [ Time Frame: 1-5 years after delivery ]
    Assessment of levator ani injury on trasnperineal 3D ultrasound images


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680731


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Tulin Ozcan, MD University of Rochester
More Information

Responsible Party: Tulin Ozcan MD, Associate Professor of Obstetrics and Gynecology, University of Rochester
ClinicalTrials.gov Identifier: NCT01680731     History of Changes
Other Study ID Numbers: 39146
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Keywords provided by Tulin Ozcan MD, University of Rochester:
Pelvic floor injury
Levator ani muscle

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Fecal Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases