Trial record 11 of 56 for:
Open Studies | "Pelvic Floor"
3D Ultrasound in Women With Vacuum or Forceps Deliveries (VADUS)
This study is currently recruiting participants.
Verified March 2013 by University of Rochester
Sponsor:
University of Rochester
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01680731
First received: September 4, 2012
Last updated: March 29, 2013
Last verified: March 2013
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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
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | October 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
Contacts
| Contact: Tulin Ozcan, MD | 585-275-7480 | tulin_ozcan@urmc.rochester.edu |
| Contact: Linda Leoni, RN, MS | 585-275-3160 | linda_leoni@urmc.rochester.edu |
Locations
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Tulin Ozcan, MD 585-275-7480 tulin_ozcan@urmc.rochester.edu | |
| Contact: Linda Leoni, RN, MS 585-2753160 | |
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: | March 29, 2013 |
| 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 Rectal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013