Impact of Pelvic Floor Musculature on Peripartum Outcomes (PregUS)
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Purpose
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.
| Condition |
|---|
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Pregnancy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study |
- Serial changes in pelvic floor anatomy and function [ Time Frame: 12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum ] [ Designated as safety issue: No ]To evaluate the serial changes in pelvic floor anatomy and function during the second, third trimester of pregnancy and in the postpartum period.
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Prenatal visits
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.
Contacts and Locations| Contact: Tulin Ozcan, MD | 585-275-7480 | tulin_ozcan@urmc.rochester.edu |
| 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: Varuna Raizada, MBBS 585-273-5879 varuna_raizada@urmc.rochester.edu | |
| Principal Investigator: Tulin Ozcan, MD | |
| Principal Investigator: | Tulin Ozcan, MD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Tulin Ozcan MD, Associate Professor, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01208246 History of Changes |
| Other Study ID Numbers: | 31522 |
| Study First Received: | September 22, 2010 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013