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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01680731
First received: September 4, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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
Pelvic Floor Injury
Urinary Incontinence
Stool Incontinence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: 3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Levator ani injury on 3D ultrasound [ Time Frame: 1-5 years after delivery ] [ Designated as safety issue: No ]
    Assessment of levator ani injury on trasnperineal 3D ultrasound images


Enrollment: 45
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 4, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Pelvic floor injury
Levator ani muscle

Additional relevant MeSH terms:
Fecal Incontinence
Urinary Incontinence
Wounds and Injuries
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014