Clinical Trials Logo

Clinical Trial Summary

This study has two aims: a) to evaluate the pelvic floor muscles strength in primigravid and non-pregnant nulliparous women and to correlate with their sexual function and b) to compare PFM strength and sexual function between women in the second and third pregnancy trimesters.


Clinical Trial Description

This is an observational cross-sectional study. The sample consisted of 161 women divided into two groups: the first of pregnant women, formed by 81 primigravidae participants in the Prenatal Program of the public health system in Uberlandia city (Brazil). The second consists of 80 non-pregnant nulliparous. All participants signed an informed consent and the study was approved by the Ethics Committee of the Federal University of Uberlandia (nº 145.623/2012).

To estimate the average strength of vaginal palpation and vaginal squeeze pressure in primigravid, the investigators used the following equation to scale the sample: Zα/2 refers to the probability (α/2) standard one-tailed normal distribution; σ2 is the variance associated with vaginal palpation and vaginal squeeze pressure; ε is the sampling error. Based on a similar study, which evaluated similar population, it was assumed: α=0.05, σ=1.34 and ε=0.32 for vaginal palpation; and it was assumed: α=0.05, σ=12.60 and ε=3.00 for vaginal squeeze pressure. Therefore, the sample size would be 67 and 68 women, respectively.

The PFM assessment

PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. These methods are widely used in research involving the female pelvic floor and many studies have shown its reproducibility and validity.

The same examiner conducted all evaluations and before the start of the study, the reproducibility was tested. Ten women were evaluated twice, with an interval of one week to determine the intraclass correlation coefficient (ICC) of all variables.

The participants were asked about the health history. After checking that they were eligible to participate in the survey, participants were invited to empty the bladder and to remain in the supine position with hips and knees flexed and feet propped. Assessments began after explaining how to perform the contraction of PFM and the volunteer was advised to stay relaxed and breathing normally. The vaginal palpation was always the first exam to check the PFM contraction ability and then was held vaginal squeeze pressure exam.

During vaginal palpation the examiner quantified strength. The physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the PFM, according to the instruction of a movement "inward and up" with the greatest possible strength. Muscle function was classified by the Oxford Scale Modified, with varies from zero (absence of muscle contraction) to five (strong contraction with finger sucking of the evaluator). To be considered valid, the movement of cranial elevation was observed by the examiner, as well as the absence of visible contractions of the adductor muscles of the hip, gluteus or abdominals.

The vaginal squeeze pressure was measured through perineometer equipped with a vaginal probe that has been covered with a non-lubricated condom and then the probe was lubricated with hypoallergenic gel. The probe sensor was connected to a microprocessor hand with a latex tube, which allows the measurement of nip pressure in centimeters of water. To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced approximately 4cm into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. For statistical analysis, the investigators used the mean of three peak pressures provided by the equipment.

Sexual function assessment

Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire, with a validated Portuguese version, which has an easy to understand language and subsequently was applied exclusively in Brazilian pregnant women. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The score for each question is individual, varying from 0 to 6 points. The investigators performed a mathematical calculation, which allowed the acquisition of a final index, the total score of the FSFI. The total score of FSFI ranges between 2 and 36 points. The lower the score, the worse is the sexual function is. The assessment is for the period of the last four weeks.

At the time of the interview, the pregnant women were instructed regarding the completion and they had their enough time to fill it out in a self-administered way in a reserved place.

Statistical analysis

Statistical analysis was performed using Statistical Package for Social Sciences software (SPSSV21, Chicago, IL). Data normality was tested by the Kolmogorov-Smirnov test. To perform the variables comparison, the Mann-Whitney test was performed. To verify the correlation between the variables, the Spearman correlation test was used. Values of p<0.05 were considered significant. The intensity of the relationship of the correlation coefficient values were interpreted according to the following guidelines: 0 = zero; 0.10-0.39 = weak; 0.40-0.69 = moderate; 0.70-0.99 = strong, 1 = perfect, regardless of whether positive or negative. ;


Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02866292
Study type Observational
Source Federal University of Uberlandia
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date August 2016

See also
  Status Clinical Trial Phase
Completed NCT02493647 - Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk N/A
Completed NCT03533192 - Replication of Evidence-based Programs N/A
Completed NCT02548871 - Evaluation of the Teen Outreach Program in Chicago Public Schools N/A
Completed NCT00220597 - Group Therapies for Reducing HIV-risk Behavior in Women Who Have Survived Childhood Sexual Abuse N/A
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Completed NCT04035694 - Evaluation Study of the Online High School Media Aware Program N/A
Completed NCT04070950 - Sexuality of Women With Pelvic Cancer
Completed NCT04079608 - Rigorous Evaluation of High School FLASH N/A
Completed NCT03366636 - Project Legacy Impact Evaluation Study N/A
Completed NCT02613039 - Oral Contraceptive Therapy and Sexuality Phase 4
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Withdrawn NCT01169922 - HIV Prevention With Adolescents: Neurocognitive Deficits and Treatment Response N/A
Completed NCT00249496 - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1 N/A
Completed NCT02993185 - Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention N/A
Active, not recruiting NCT01088542 - The Community Youth Development Study: A Test of Communities That Care N/A
Completed NCT03330522 - Reducing HIV Risk in Urban Women: Soap Opera Videos on Video-Capable Cell Phones N/A
Completed NCT02530645 - Development and Testing of a Smartphone Application to Reduce Substance Use and Sexual Risk Among Homeless Young Adults N/A
Completed NCT00109421 - Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females N/A
Recruiting NCT05140980 - Sexuality Education: Knowledge of Women Aged 18 to 25
Completed NCT04962802 - Evaluation of Manhood 2.0: A Community-Based Teen Pregnancy Prevention Program for Young Men N/A