Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAzienda Sanitaria Universitaria Friuli Centrale
About this trial
The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
nulliparous
single pregnancy
cephalic presentation of the fetus
Italian language fluency
Disqualifiers
multiparous
age < 18 y, age > 40 y
previous urinary or fecal incontinence
contraindications to vaginal delivery (such as placenta previa, vasa previa, etc)
Trial design
Design model
Parallel
Treatments tested in this trial
perineal massage
Behavioralwomen affected by LAM co-activation allocated to the intervention "perineal massage" are asked to perform the perineal massage once daily from 34 gestational weeks until delivery. Women are trained to correctly perform the perineal massage at 30 gestaitonal weeks.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: perineal massageExperimental treatment 1 intervention
Group B: standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test.
All women who consent to participate in the study will be scanned through a trans-perineal ultrasound at 20 weeks. Co-activation is defined when the levator ani muscle antero-posterior diameter under Valsalva manueuver is lower than the same diameter measured at rest, with trans-perineal ultrasound. In case of LAM co-activation women will be recruited and randomized into two groups: the perineal massage group vs the standard care group. All randomized women will be evaluated with trans-perineal ultrasound for the levator ani muscle antero-posterior diameter measurement at 37-38 gestational weeks. To evaluate the effectiveness of the perineal massage, the percentages of women without LAM co-activation after treatment or after standard care, evaluated at 37-38 weeks, will be compared. For the comparison a chi square test will be used.
Time frame
at 20 gestational weeks and at 37-40 gestational weeksSecondary outcomes
1
Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups
The comparisons between groups will occur through chi-square tests for categorical variables and Student's t-tests for continuous variables. Vaginal tears are classified into first- degree, second- degree vaginal laceration, obstetric anal sphincter injury (OASI) and episiotomy
Time frame
immediately after fetus delivery2
percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery.
for the effectiveness of perineal massage, participants in the "perineal massage" arm should perform the massage once a day, at least 5 days a week, from 34 gestational weeks until delivery. Participants will be asked to complete a diary, noting the days on which they perform the perineal massage.
Time frame
from 34 gestational weeks until the moment of delivery (between 37 weeks and 41 weeks and 3 days of gestation).Sponsors and contacts
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Source ClinicalTrials.gov