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OpenTrials
Completed

NCT Number: NCT01208246

Impact of Pelvic Floor Musculature on Peripartum Outcomes

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study

Acronym: PregUS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 23, 2010
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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