NCT01208246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

September 22, 2010

Last Update Submit

February 19, 2014

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Serial changes in pelvic floor anatomy and function

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

    12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Prenatal visits

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Study Officials

  • Tulin Ozcan, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 22, 2010

First Posted

September 23, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

US(1)