- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01208246
Impact of Pelvic Floor Musculature on Peripartum Outcomes (PregUS)
February 19, 2014 updated by: Tulin Ozcan MD, University of Rochester
Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study
The purpose of this study is to understand the effect of the pregnancy on the muscles in the pelvis.
The purpose of this study is to evaluate the pelvic muscle changes related to pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on delivery mode and if there are any injuries to the pelvic muscles.
Study Overview
Status
Completed
Conditions
Detailed Description
Healthy women who are pregnant with their first child will be included in the study.
Information about their general health will be gathered.
These women will be screened for pelvic disorders at the start and end of study.
Three-dimensional ultrasound will be performed three times: 12-24 weeks, 34-39 weeks and 4-6 weeks after delivery.
Fetal measurements will be included in the third trimester ultrasound for prediction of estimated birth weight.
The relationship of the predicted fetal weight and the likelihood of having a successful vaginal delivery will be studied.
Images will be analyzed for pelvic muscles function and injuries.
Information regarding the length of labor, types of delivery and vaginal tears will be gathered.
The information obtained will be analyzed to look for the strength of correlation of variables to the outcomes.
Study Type
Observational
Enrollment (Actual)
34
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Prenatal visits
Description
Inclusion Criteria:
- Primiparous or should not have given birth to a fetus older than 12 weeks.
- Singleton pregnancy.
- Age more than or equal to 18 years.
- Basal mass index between 18 - 40 kg/m2.
- Must plan to deliver at Strong Memorial Hospital at the University of Rochester Medical Center.
Exclusion Criteria:
- Basal mass index more than 40 kg/m2.
- Presence of current or prior history of cervical incompetence.
- Presence of diabetes mellitus (type I or type II).
- Presence of connective-tissue disorders such as Systemic lupus erythematosus, Rheumatoid Arthritis, or Sjogren's disease.
- Presence of neuromuscular disorders such as myasthenia gravis and neuropathies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serial changes in pelvic floor anatomy and function
Time Frame: 12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum
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To evaluate the serial changes in pelvic floor anatomy and function during the second, third trimester of pregnancy and in the postpartum period.
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12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tulin Ozcan, MD, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
September 22, 2010
First Submitted That Met QC Criteria
September 22, 2010
First Posted (Estimate)
September 23, 2010
Study Record Updates
Last Update Posted (Estimate)
February 21, 2014
Last Update Submitted That Met QC Criteria
February 19, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 31522
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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