Pelvic Floor DisordersCO-LAM23NCT06296134
Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation
A study testing perineal massage in people with Pelvic Floor Disorders and Levator Ani Syndrome, run by Azienda Sanitaria Universitaria Friuli Centrale at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Levator Ani Syndrome
- What is being tested?
- perineal massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- multiparous
- age < 18 y, age > 40 y
- previous urinary or fecal incontinence
- contraindications to vaginal delivery (such as placenta previa, vasa previa, etc)
- twin pregnancy
- language barrier
- BMI at or > 30
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Serena Xodo
Udine, 33100
Serena Xodo, 0432-559699, serena.xodo@gmail.com
About this study
Official title: Does Perineal Massage in Pregnancy Reduce the Levator Ani Muscle Co-activation?
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.
Read the detailed description
The levator ani muscle has to relax instead of contracting during the pushing efforts in childbirth. However, some women consciously or unconsciously co-contract, or tighten, the levator ani muscle. This phenomenon is levator ani muscle co-activation. Recently, it has been shown that co-activation may be associated with unfavorable obstetric outcomes, such as prolonged second stages of labor and higher fetal head station in women with co-contraction.
Recently, a study assessing the correlation between levator ani muscle co-activation and perineal trauma has been published. This study found a significantly higher incidence of severe perineal trauma related to childbirth (i.e., third and fourth-degree lacerations and episiotomies) in women with levator ani muscle co-activation. This group of patients had approximately three times the risk of a vacuum-assisted vaginal delivery and five times the risk of developing a severe vagino-perineal laceration with potential involvement of the anal sphincter. Therefore, intervening in these patients with targeted measures to correct LAM co-activation in the third trimester of pregnancy might be promising.
Study design All women are informed about this study during the first trimester of pregnancy. During the anatomical scan, at 20-22 gestational weeks, women are screened for eligibility criteria, including: nulliparity, single pregnancy, fetus in cephalic presentation and fluency in Italian language. Women satisfying the inclusion criteria are asked to participate to this RCT. If women agree to participate in the study, an informed consent will be signed. Thereafter, a trans-perineal ultrasound will be performed in order to evaluate the presence of levator ani muscle co-activation. A medio-sagittal scan is obtained to identify the following landmarks: pubic symphysis, fetal head, rectum, and puborectal muscle. In this scan, the antero-posterior diameter of the anorectal angle (APD) is measured, which is the minimum distance between the postero-inferior border of the pubic symphysis and the anterior border of the puborectal muscle. This measurement is taken both at rest and during maternal pushing (Valsalva maneuver). Patients with co-activation will be identified by an APD during Valsalva that is smaller than the one observed at rest. Patients will be enrolled and randomized only in case of LAM co-activation.
A 1:1 randomization will be done using a specific function of Excel (preliminarily prepared by our Statistician). Women will be randomized in 2 arms: arm A is represented by the treatment "perineal massage", while arm B is represented by the "standard care".
At about 30 gestational weeks women randomized to arm A will be trained on how technically perform the perineal massage. Participants are instructed to do the perineal massage once daily from 34 gestational weeks until delivery, for at least 3 weeks continuously. By contrast, women randomized to arm B are informed on currently available recommendations to take care for pelvic floor in pregnancy. These recommendations include advices on healthy diet, physical activity and voiding training.
At 37-38 gestational weeks all randomized women are scanned again in order to measure the APD at rest and under Valsalva. All anthropometric and clinical data are collected and anonymized.
Intra-partum part of the study This part of the project involves data collection on labor, delivery, and neonatal outcomes. The labor and delivery care-providers operate blindly with respect to the antepartum ultrasound measurements.
The study was powered based on the primary endpoint, which is the 40% reduction in LAM co-activation at term after perineal massage therapy. It is necessary to randomize 58 subjects (29 women per group).
The primary outcome of this trial is to assess whether the intervention "perineal massage", compared to the standard care, is able to significantly reduce the levator ani co-activation. Secondary outcomes are the standardization of the perineal massage and the comparison of perineal trauma prevalence between the 2 arms.
- Conditions
- Pelvic Floor Disorders, Levator Ani Syndrome
- Being tested
- perineal massage
- Medical subject headings
- Pelvic Floor Disorders, Levator syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal massageBehavioural
women 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.
| Study group | Role | What they receive |
|---|---|---|
| perineal massage | Experimental | participants randomized to this arm are asked to perform themselves the perineal massage once daily from 34 gestational weeks until delivery. Receives: Behavioral: perineal massage |
| standard care | No intervention | participants randomized to this arm are asked to care for their pelvic floor according to the standard practice, which includes healthy diet, weight gain control, physical activity and voiding training therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 20 gestational weeks and at 37-40 gestational weeks
Secondary outcomes (2)
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
Measured: immediately after fetus delivery
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.
Measured: from 34 gestational weeks until the moment of delivery (between 37 weeks and 41 weeks and 3 days of gestation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Universitaria Friuli Centrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296134
- Sponsor's protocol ID
- 17501
- Acronym
- CO-LAM23
- Status last verified
- Aug 2024
- First submitted
- 14 Feb 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Orno AK, Dietz HP. Levator co-activation is a significant confounder of pelvic organ descent on Valsalva maneuver. Ultrasound Obstet Gynecol. 2007 Sep;30(3):346-50. doi: 10.1002/uog.4082.
PubMed 17702054Kamel R, Montaguti E, Nicolaides KH, Soliman M, Dodaro MG, Negm S, Pilu G, Momtaz M, Youssef A. Contraction of the levator ani muscle during Valsalva maneuver (coactivation) is associated with a longer active second stage of labor in nulliparous women undergoing induction of labor. Am J Obstet Gynecol. 2019 Feb;220(2):189.e1-189.e8. doi: 10.1016/j.ajog.2018.10.013. Epub 2018 Oct 12.
PubMed 30321525Brunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31.
PubMed 32865824Youssef A, Montaguti E, Dodaro MG, Kamel R, Rizzo N, Pilu G. Levator ani muscle coactivation at term is associated with longer second stage of labor in nulliparous women. Ultrasound Obstet Gynecol. 2019 May;53(5):686-692. doi: 10.1002/uog.20159. Epub 2019 Apr 2.
PubMed 30353589Youssef A, Brunelli E, Montaguti E, Di Donna G, Dodaro MG, Bianchini L, Pilu G. Transperineal ultrasound assessment of maternal pelvic floor at term and fetal head engagement. Ultrasound Obstet Gynecol. 2020 Dec;56(6):921-927. doi: 10.1002/uog.21982.
PubMed 31975450Youssef A, Brunelli E, Fiorentini M, Pilu G, El-Balat A. The correlation between levator ani co-activation and fetal head regression on maternal pushing at term. J Matern Fetal Neonatal Med. 2022 Dec;35(25):9654-9660. doi: 10.1080/14767058.2022.2050363. Epub 2022 Mar 13.
PubMed 35282757Beckmann MM, Stock OM. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD005123. doi: 10.1002/14651858.CD005123.pub3.
PubMed 23633325
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perineal Massage in Pregnancy Reduce the Levator Ani Muscle Co-activation?
- ClinicalTrials.gov ID
- NCT06296134
- Acronym / sponsor ID
- CO-LAM23 / 17501
- Conditions
- Pelvic Floor Disorders, Levator Ani Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Universitaria Friuli CentraleUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The levator ani muscle has to relax instead of contracting during the pushing efforts in childbirth. However, some women consciously or unconsciously co-contract, or tighten, the levator ani muscle. This phenomenon is levator ani muscle co-activation. Recently, it has been shown that co-activation may be associated with unfavorable obstetric outcomes, such as prolonged second stages of labor and higher fetal head station in women with co-contraction.
Recently, a study assessing the correlation between levator ani muscle co-activation and perineal trauma has been published. This study found a significantly higher incidence of severe perineal trauma related to childbirth (i.e., third and fourth-degree lacerations and episiotomies) in women with levator ani muscle co-activation. This group of patients had approximately three times the risk of a vacuum-assisted vaginal delivery and five times the risk of developing a severe vagino-perineal laceration with potential involvement of the anal sphincter. Therefore, intervening in these patients with targeted measures to correct LAM co-activation in the third trimester of pregnancy might be promising.
Study design All women are informed about this study during the first trimester of pregnancy. During the anatomical scan, at 20-22 gestational weeks, women are screened for eligibility criteria, including: nulliparity, single pregnancy, fetus in cephalic presentation and fluency in Italian language. Women satisfying the inclusion criteria are asked to participate to this RCT. If women agree to participate in the study, an informed consent will be signed. Thereafter, a trans-perineal ultrasound will be performed in order to evaluate the presence of levator ani muscle co-activation. A medio-sagittal scan is obtained to identify the following landmarks: pubic symphysis, fetal head, rectum, and puborectal muscle. In this scan, the antero-posterior diameter of the anorectal angle (APD) is measured, which is the minimum distance between the postero-inferior border of the pubic symphysis and the anterior border of the puborectal muscle. This measurement is taken both at rest and during maternal pushing (Valsalva maneuver). Patients with co-activation will be identified by an APD during Valsalva that is smaller than the one observed at rest. Patients will be enrolled and randomized only in case of LAM co-activation.
A 1:1 randomization will be done using a specific function of Excel (preliminarily prepared by our Statistician). Women will be randomized in 2 arms: arm A is represented by the treatment "perineal massage", while arm B is represented by the "standard care".
At about 30 gestational weeks women randomized to arm A will be trained on how technically perform the perineal massage. Participants are instructed to do the perineal massage once daily from 34 gestational weeks until delivery, for at least 3 weeks continuously. By contrast, women randomized to arm B are informed on currently available recommendations to take care for pelvic floor in pregnancy. These recommendations include advices on healthy diet, physical activity and voiding training.
At 37-38 gestational weeks all randomized women are scanned again in order to measure the APD at rest and under Valsalva. All anthropometric and clinical data are collected and anonymized.
Intra-partum part of the study This part of the project involves data collection on labor, delivery, and neonatal outcomes. The labor and delivery care-providers operate blindly with respect to the antepartum ultrasound measurements.
The study was powered based on the primary endpoint, which is the 40% reduction in LAM co-activation at term after perineal massage therapy. It is necessary to randomize 58 subjects (29 women per group).
The primary outcome of this trial is to assess whether the intervention "perineal massage", compared to the standard care, is able to significantly reduce the levator ani co-activation. Secondary outcomes are the standardization of the perineal massage and the comparison of perineal trauma prevalence between the 2 arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineal massage | Experimental | Behavioral: perineal massageparticipants randomized to this arm are asked to perform themselves the perineal massage once daily from 34 gestational weeks until delivery. |
| standard care | No intervention | –participants randomized to this arm are asked to care for their pelvic floor according to the standard practice, which includes healthy diet, weight gain control, physical activity and voiding training therapy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- multiparous
- age < 18 y, age > 40 y
- previous urinary or fecal incontinence
- contraindications to vaginal delivery (such as placenta previa, vasa previa, etc)
- twin pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perineal massagewomen 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. | Behavioural | perineal massage |
Primary outcome
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.
Time frame: at 20 gestational weeks and at 37-40 gestational weeks
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.
2 secondary outcomes
Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups
Time frame: immediately after fetus delivery
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.
Time frame: from 34 gestational weeks until the moment of delivery (between 37 weeks and 41 weeks and 3 days of gestation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 17702054Orno AK, Dietz HP. Levator co-activation is a significant confounder of pelvic organ descent on Valsalva maneuver. Ultrasound Obstet Gynecol. 2007 Sep;30(3):346-50. doi: 10.1002/uog.4082.
- Background: PubMed 30321525Kamel R, Montaguti E, Nicolaides KH, Soliman M, Dodaro MG, Negm S, Pilu G, Momtaz M, Youssef A. Contraction of the levator ani muscle during Valsalva maneuver (coactivation) is associated with a longer active second stage of labor in nulliparous women undergoing induction of labor. Am J Obstet Gynecol. 2019 Feb;220(2):189.e1-189.e8. doi: 10.1016/j.ajog.2018.10.013. Epub 2018 Oct 12.
- Background: PubMed 32865824Brunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31.
- Background: PubMed 30353589Youssef A, Montaguti E, Dodaro MG, Kamel R, Rizzo N, Pilu G. Levator ani muscle coactivation at term is associated with longer second stage of labor in nulliparous women. Ultrasound Obstet Gynecol. 2019 May;53(5):686-692. doi: 10.1002/uog.20159. Epub 2019 Apr 2.
- Background: PubMed 31975450Youssef A, Brunelli E, Montaguti E, Di Donna G, Dodaro MG, Bianchini L, Pilu G. Transperineal ultrasound assessment of maternal pelvic floor at term and fetal head engagement. Ultrasound Obstet Gynecol. 2020 Dec;56(6):921-927. doi: 10.1002/uog.21982.
- Background: PubMed 35282757Youssef A, Brunelli E, Fiorentini M, Pilu G, El-Balat A. The correlation between levator ani co-activation and fetal head regression on maternal pushing at term. J Matern Fetal Neonatal Med. 2022 Dec;35(25):9654-9660. doi: 10.1080/14767058.2022.2050363. Epub 2022 Mar 13.
- Background: PubMed 23633325Beckmann MM, Stock OM. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD005123. doi: 10.1002/14651858.CD005123.pub3.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineal massage in people with Pelvic Floor Disorders and Levator Ani Syndrome, run by Azienda Sanitaria Universitaria Friuli Centrale at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Xodo, M.D. (0432-559699, serena.xodo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at 20 gestational weeks and at 37-40 gestational weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296134, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.