Impact of Pelvic Floor Musculature on Peripartum Outcomes (PregUS)
This study has been completed.
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester
First received: September 22, 2010
Last updated: February 19, 2014
Last verified: February 2014
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2014 (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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208246
|University of Rochester
|Rochester, New York, United States, 14642 |
University of Rochester
||Tulin Ozcan, MD
||University of Rochester
No publications provided
ClinicalTrials.gov processed this record on August 28, 2014
||Tulin Ozcan MD, Associate Professor, University of Rochester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 22, 2010
||February 19, 2014
||United States: Institutional Review Board