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PregUS: Impact of Pelvic Floor Musculature on Peripartum Outcomes

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT01208246
Collaborator
(none)
34
Enrollment
1
Location
45
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    34 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2014
    Actual Study Completion Date :
    Jan 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Serial changes in pelvic floor anatomy and function [12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum]

      To evaluate the serial changes in pelvic floor anatomy and function during the second, third trimester of pregnancy and in the postpartum period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    • Principal Investigator: Tulin Ozcan, MD, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tulin Ozcan MD, Associate Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT01208246
    Other Study ID Numbers:
    • 31522
    First Posted:
    Sep 23, 2010
    Last Update Posted:
    Feb 21, 2014
    Last Verified:
    Feb 1, 2014

    Study Results

    No Results Posted as of Feb 21, 2014