Clinical Trials Directory

Trials / Completed

CompletedNCT01315769

Pelvic Floor Muscle Function in Nulliparous and Primiparous.

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
UPECLIN HC FM Botucatu Unesp · Academic / Other
Sex
Female
Age
20 Years – 30 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Timeline

Start date
2006-03-01
Completion
2006-09-01
First posted
2011-03-15
Last updated
2011-03-15

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01315769. Inclusion in this directory is not an endorsement.