Impact of Pelvic Floor Musculature on Peripartum Outcomes

NCT ID: NCT01208246

Last Updated: 2014-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Tulin Ozcan MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tulin Ozcan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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31522

Identifier Type: -

Identifier Source: org_study_id

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