Impact of Pelvic Floor Musculature on Peripartum Outcomes (PregUS)
This study is currently recruiting participants.
Verified March 2013 by University of Rochester
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester
First received: September 22, 2010
Last updated: March 29, 2013
Last verified: March 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208246
University of Rochester
||Tulin Ozcan, MD
||University of Rochester
No publications provided
ClinicalTrials.gov processed this record on May 16, 2013
||Tulin Ozcan MD, Associate Professor, University of Rochester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 22, 2010
||March 29, 2013
||United States: Institutional Review Board