Impact of Pelvic Floor Musculature on Peripartum Outcomes (PregUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tulin Ozcan MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01208246
First received: September 22, 2010
Last updated: February 19, 2014
Last verified: February 2014
  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
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

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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.


Enrollment: 34
Study Start Date: April 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Prenatal visits

Criteria

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
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

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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: February 19, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 15, 2014