Pelvic Floor Muscle Function in Nulliparous and Primiparous.

March 14, 2011 updated by: UPECLIN HC FM Botucatu Unesp

COMPARATIVE STUDY OF PELVIC FLOOR MUSCLE EVALUATION IN NULIPAROUS AND PRIMIPAROUS WOMEN. A Prospective Study

This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and primiparous women. Subjective evaluation of PFM strength was performed vaginal digital palpation (TDP). The objective evaluation of PFM strength was assessed using a portable perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th and 36th weeks of pregnancy, and 45 days after the delivery. Pregnancy and vaginal delivery may cause weakness of PFM.

Study Overview

Status

Completed

Conditions

Detailed Description

Objective: This study aimed to compare the pelvic floor muscle (PFM) strength in nulliparous and primiparous women. Populations: The sample size was established considering a significance level of 5%, the test power of 80%, and the estimated error of 10%. According to these results and considering the range between percentages of answers as the casual error, each group was established with approximately 50 participants. Methods: 100 women were prospectively distributed into: Group G1 (n = 50) comprising by healthy nulliparous women; Group G2 (n = 50) with primiparous ones. Subjective evaluation of PFM strength was performed using transvaginal digital palpation (TDP). The objective evaluation of PFM strength was assessed using a portable perineometer. All parameters were performed at one moment in G1, and in G2, during the 20th and 36th weeks of pregnancy, and 45 days after the delivery. Results: In G2, 14 women were excluded due to the lost follow-up. The median of age was 23 years in G1 and 22, in G2, there was no statistical difference between the groups. In G1, BMI was in average 21.7 Kg/m2, and 25,0 Kg/m2 in G2, there was statistical difference between the groups (p= 0.0004). In G2, TDP evaluation showed a significant impairment of PFM strength at 36th week of pregnancy (p=0,0006) and 45 days after the vaginal delivery (p=0.0001) compared to nulliparous. Objective evaluations of PFM strength showed a significant decrease 45 days after vaginal delivery compared to nulliparas. Conclusion: Pregnancy and vaginal delivery may cause weakness of PFM.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-970
        • Medical School of Botucatu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The sample size was established considering a significance level of 5%, the test power of 80%, and the estimated error of 10%. According to these results and considering the range between percentages of answers as the casual error, each group was established with approximately 50 participants.

Description

Inclusion Criteria:

- Nulliparous and primiparous

Exclusion Criteria:

  • in G1 (nulliparous) were UI, neurological diseases, previous pelvic surgeries, diabetes, smoking and cognitive difficulties. In G2 (primiparas), the same criteria were used including women with gestational complications such as diabetes, hypertension, vaginal and urinary infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
non pregnant nulliparous
Group 1
primiparous women
Group 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Principal Investigator: Joao L Amaro, PhD MD, Urology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (ESTIMATE)

March 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2011

Last Update Submitted That Met QC Criteria

March 14, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-51

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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