Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation

NCT06296134 | Recruiting

• 1 other identifier: 17501
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pelvic Floor Disorders; Levator Ani Syndrome

Outcome Measures

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.

  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

  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.

  from 34 gestational weeks until the moment of delivery (between 37 weeks and 41 weeks and 3 days of gestation).

Study Arms (2)

perineal massage

EXPERIMENTAL

participants randomized to this arm are asked to perform themselves the perineal massage once daily from 34 gestational weeks until delivery.

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.

Interventions

perineal massage BEHAVIORAL

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.

perineal massage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• nulliparous
• single pregnancy
• cephalic presentation of the fetus
• Italian language fluency

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Universitaria Friuli Centrale: lead

Study Sites (1)

Serena Xodo

Udine, 33100, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 17702054 BACKGROUND

• Kamel 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.

  PMID: 30321525 BACKGROUND

• Brunelli 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.

  PMID: 32865824 BACKGROUND

• Youssef 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.

  PMID: 30353589 BACKGROUND

• Youssef 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.

  PMID: 31975450 BACKGROUND

• Youssef 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.

  PMID: 35282757 BACKGROUND

• Beckmann 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.

  PMID: 23633325 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Levator syndrome

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Central Study Contacts

Serena Xodo, M.D.

CONTACT

0432-559699; serena.xodo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 6, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: immediately after publication
• Access Criteria: to gain access data requestors should contact the principal investigator: Serena Xodo, e-mail: serena.xodo@gmail.com

Locations

IT (1)