Impact of Pelvic Floor Musculature on Peripartum Outcomes (PregUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01208246
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : February 21, 2014
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester

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

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
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 : April 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Primary Outcome Measures :
  1. Serial changes in pelvic floor anatomy and function [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01208246

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Tulin Ozcan, MD University of Rochester

Responsible Party: Tulin Ozcan MD, Associate Professor, University of Rochester Identifier: NCT01208246     History of Changes
Other Study ID Numbers: 31522
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014