NCT01315769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Shorter than P25 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

March 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

First QC Date

March 14, 2011

Last Update Submit

March 14, 2011

Conditions

Investigation or Care in A Nonpregnant WomanMother (Person)

Study Arms (2)

non pregnant nulliparous

Group 1

primiparous women

Group 2

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • \- Nulliparous and primiparous

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School of Botucatu

Botucatu, São Paulo, 18618-970, Brazil

Location

Study Officials

  • Joao L Amaro, PhD MD

    Urology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

March 1, 2006

Study Completion

September 1, 2006

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

BR(1)