Pelvic Floor InjuryVADUSNCT01680731
3D Ultrasound in Women With Vacuum or Forceps Deliveries
An observational study of Pelvic Floor Injury and Urinary Incontinence, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pelvic Floor Injury, Urinary Incontinence, Stool Incontinence
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries
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.
- Keywords
- Pelvic floor injury, Levator ani muscle
- Medical subject headings
- Urinary Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levator ani injury on 3D ultrasound
Assessment of levator ani injury on trasnperineal 3D ultrasound images
Measured: 1-5 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor InjuryStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulin Ozcan MD, University of Rochester
- Investigators
- Tulin Ozcan, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680731
- Sponsor's protocol ID
- 39146
- Acronym
- VADUS
- Status last verified
- Feb 2014
- First submitted
- 4 Sep 2012
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries
- ClinicalTrials.gov ID
- NCT01680731
- Acronym / sponsor ID
- VADUS / 39146
- Keywords
- Pelvic floor injury, Levator ani muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levator ani injury on 3D ultrasound
Time frame: 1-5 years after delivery
Assessment of levator ani injury on trasnperineal 3D ultrasound images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tulin Ozcan, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Injury and Urinary Incontinence, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levator ani injury on 3D ultrasound (time frame: 1-5 years after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2014.