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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04431102
Other study ID # CFMP14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2018
Est. completion date December 27, 2019

Study information

Verified date June 2020
Source University of Huelva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.


Description:

It is postulated that in pregnang women, the practice of PM can reduce the severity of birth injuries.

Our main objective was to determine the effectiveness of a PM program to reduce the incidence and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.

Secondary objectives were:

Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the effect of a MP program on body weight (BMI).

It is a parallel group clinical trial with an allocation ratio of 1:2.

All pregnant women will be informed about the nature of the clinical trial. There will be no differences in the pregnant´s follow-up because it will be performed by two same Pilates monitor with the same formation.

Once the pregnant women is assigned to an arm of the study, those assigned to the intervention group will be sent to the Pilates monitor to explain and initiate the exercise of MP program while the control group will be informed to maintain their usual monitoring of pregnancy.

In the initial visit, the type of physical activity will be evaluated by filling in the international physical activity questionnaire (IPAQ).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 27, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- To go to the Maternal Education program.

- Give your written consent to participate in the study.

- Singleton pregnancy.

- Low-risk pregnancy.

- No contraindication to physical exercise.

- Age equals or more than 18 years old.

Excusion Criteria:

- Pregnant women with poor pregnancy control.

- Difficulty in speaking or understanding Spanish.

- Required a C-section during delivery.

- Refusal to participate in the study.

Study Design


Intervention

Other:
PILATES METHOD
It is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week. The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women. The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day.

Locations

Country Name City State
Spain Carmen Feria Ramírez Lepe Huelva

Sponsors (1)

Lead Sponsor Collaborator
University of Huelva

Country where clinical trial is conducted

Spain, 

References & Publications (40)

Aguiar M, Farley A, Hope L, Amin A, Shah P, Manaseki-Holland S. Birth-Related Perineal Trauma in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis. Matern Child Health J. 2019 Aug;23(8):1048-1070. doi: 10.1007/s10995-019-02732-5. — View Citation

Almagiá E. Influencia del estado emocional en la salud física. Terapia psicológica. 2003; 21(1): 38.

Boix-Vilella S, León-Zarceño E, Serrano-Rosa MA. Evidencias de la práctica Pilates sobre la salud mental de personas sanas. Rev Universidad y Salud. 2017; 19(2): 301-308.

Bozkurt M, Yumru AE, Sahin L. Pelvic floor dysfunction, and effects of pregnancy and mode of delivery on pelvic floor. Taiwan J Obstet Gynecol. 2014 Dec;53(4):452-8. doi: 10.1016/j.tjog.2014.08.001. Review. — View Citation

Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation

Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24. Review. — View Citation

Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22. — View Citation

D'Souza JC, Monga A, Tincello DG. Risk factors for perineal trauma in the primiparous population during non-operative vaginal delivery. Int Urogynecol J. 2020 Mar;31(3):621-625. doi: 10.1007/s00192-019-03944-7. Epub 2019 May 2. — View Citation

Davidson K, Jacoby S, Brown MS. Prenatal perineal massage: preventing lacerations during delivery. J Obstet Gynecol Neonatal Nurs. 2000 Sep-Oct;29(5):474-9. — View Citation

Dias NT, Ferreira LR, Fernandes MG, Resende APM, Pereira-Baldon VS. A Pilates exercise program with pelvic floor muscle contraction: Is it effective for pregnant women? A randomized controlled trial. Neurourol Urodyn. 2018 Jan;37(1):379-384. doi: 10.1002/nau.23308. Epub 2017 May 23. — View Citation

Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2. — View Citation

Escuriet R, Pueyo MJ, Perez-Botella M, Espada X, Salgado I, Gómez A, Biescas H, Espiga I, White J, Fernandez R, Fusté J, Ortún V. Cross-sectional study comparing public and private hospitals in Catalonia: is the practice of routine episiotomy changing? BMC Health Serv Res. 2015 Mar 11;15:95. doi: 10.1186/s12913-015-0753-z. — View Citation

Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an update. Birth. 2005 Sep;32(3):219-23. — View Citation

Guzmán P, Díaz AM, Gómez D, Guzmán R, Guzmán A. Actuación del fisioterapeuta en el tratamiento integral de la embarazada. Nure Investigación. 2013; 2(63): 1-8.

Howard D, Makhlouf M. Can pelvic floor dysfunction after vaginal birth be prevented? Int Urogynecol J. 2016 Dec;27(12):1811-1815. Epub 2016 Aug 15. — View Citation

Hyakutake MT, Han V, Cundiff GW, Baerg L, Koenig NA, Lee T, Geoffrion R. Pelvic Floor Health Education: Can a Workshop Enhance Patient Counseling During Pregnancy? Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):336-9. doi: 10.1097/SPV.0000000000000285. — View Citation

Jansson MH, Nilsson K, Franzén K. Development and validation of a protocol for documentation of obstetric perineal lacerations. Int Urogynecol J. 2019 Dec;30(12):2069-2076. doi: 10.1007/s00192-019-03915-y. Epub 2019 Mar 19. — View Citation

Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. Cochrane Database Syst Rev. 2017 Feb 8;2:CD000081. doi: 10.1002/14651858.CD000081.pub3. Review. — View Citation

Kyvernitakis I, Köhler C, Schmidt S, Misselwitz B, Großmann J, Hadji P, Kalder M. Impact of maternal body mass index on the cesarean delivery rate in Germany from 1990 to 2012. J Perinat Med. 2015 Jul;43(4):449-54. doi: 10.1515/jpm-2014-0126. — View Citation

Latorre GFS, de Fraga R, Seleme MR, Mueller CV, Berghmans B. An ideal e-health system for pelvic floor muscle training adherence: Systematic review. Neurourol Urodyn. 2019 Jan;38(1):63-80. doi: 10.1002/nau.23835. Epub 2018 Oct 30. Review. — View Citation

Leon-Larios F, Corrales-Gutierrez I, Casado-Mejía R, Suarez-Serrano C. Influence of a pelvic floor training programme to prevent perineal trauma: A quasi-randomised controlled trial. Midwifery. 2017 Jul;50:72-77. doi: 10.1016/j.midw.2017.03.015. Epub 2017 Mar 27. — View Citation

Llewellyn H, Konstantaki M, Johnson MI, Francis P. The Effect of a Pilates Exercise Programme on Perceived Functional Disability and Pain Associated with Non-Specific Chronic Low Back Pain. MOJ Yoga & Physical Therapy. 2017; 2(1): 00013.

López M, Palacio M, del Pino M, Puig M, Bataller E, Espuña M. Protocolo: lesiones perineales de origen obstétrico. Diagnóstico, tratamiento y seguimiento. Servei de Medicina Maternofetal. Barcelona. Institut Clínic de Ginecologia, Obstetrícia i Neonatologia, Hospital Clínic de Barcelona. 2014.

Maczka M, Sass A. Pilates and mobilization methods in therapy for low back pain among pregnant women. Journal of Exercise Science & Fitness. 2017; 7(8): 473-488.

Navarro CL, Luján MI. Nuevos sistemas de comunicación del método Pilates en embarazo y puerperio. Revista Española de Comunicación en Salud. 2017; 8(1): 20-28.

Neels H, Wyndaele JJ, Tjalma WA, De Wachter S, Wyndaele M, Vermandel A. Knowledge of the pelvic floor in nulliparous women. J Phys Ther Sci. 2016 May;28(5):1524-33. doi: 10.1589/jpts.28.1524. Epub 2016 May 31. — View Citation

Oblasser C, McCourt C, Hanzal E, Christie J. Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a protocol for a randomised controlled feasibility trial. J Adv Nurs. 2016 Apr;72(4):900-14. doi: 10.1111/jan.12868. Epub 2015 Dec 28. — View Citation

Oktaviani I. Pilates workouts can reduce pain in pregnant women. Complement Ther Clin Pract. 2018 May;31:349-351. doi: 10.1016/j.ctcp.2017.11.007. Epub 2017 Nov 16. — View Citation

Organización Mundial de la Salud.Cuidados en el parto normal: una guía práctica. Revista Hospital Materno Infantil Ramón Sardá. 1999; 18: 78-80.

Pierce H, Perry L, Gallagher R, Chiarelli P. Pelvic floor health: a concept analysis. J Adv Nurs. 2015 May;71(5):991-1004. doi: 10.1111/jan.12628. Epub 2015 Feb 10. — View Citation

Rise E, Bø K, Nystad W. Is there any association between abdominal strength training before and during pregnancy and delivery outcome? The Norwegian Mother and Child Cohort Study. Braz J Phys Ther. 2019 Mar - Apr;23(2):108-115. doi: 10.1016/j.bjpt.2018.06.006. Epub 2018 Jul 6. — View Citation

Rodríguez-Díaz L, Ruiz-Frutos C, Vázquez-Lara JM, Ramírez-Rodrigo J, Villaverde-Gutiérrez C, Torres-Luque G. Effectiveness of a physical activity programme based on the Pilates method in pregnancy and labour. Enferm Clin. 2017 Sep - Oct;27(5):271-277. doi: 10.1016/j.enfcli.2017.05.008. Epub 2017 Jul 6. English, Spanish. — View Citation

Sarpkaya D.S., Yalvaç M. & Vural G. The effect of pregnancy Pilates-assisted childbirth preparation training on childbirth fear and neonatal outcomes: a quasi-experimental/quantitative research. Quality & Quantitive. 2018; 1-13.

Shaban MM, Bassiouny YA, Elzahaby IM, Hassan AA. Body mass index and labour outcome in Egyptian women. J Obstet Gynaecol. 2014 Apr;34(3):248-50. doi: 10.3109/01443615.2013.844113. Epub 2013 Dec 2. — View Citation

Smith LA, Price N, Simonite V, Burns EE. Incidence of and risk factors for perineal trauma: a prospective observational study. BMC Pregnancy Childbirth. 2013 Mar 7;13:59. doi: 10.1186/1471-2393-13-59. — View Citation

Uccella S, Manzoni P, Marconi N, Toscani C, Biasoli S, Cianci S, Franchi M, Sorice P, Bertoli F, Zorzato PC, Gallina D, Ghezzi F, Serati M. Impact of Sport Activity and Physical Exercise on Obstetrical and Perineal Outcomes at Delivery: A Prospective Study. Am J Perinatol. 2019 Jul;36(S 02):S83-S90. doi: 10.1055/s-0039-1691816. Epub 2019 Jun 25. — View Citation

Verghese TS, Champaneria R, Kapoor DS, Latthe PM. Obstetric anal sphincter injuries after episiotomy: systematic review and meta-analysis. Int Urogynecol J. 2016 Oct;27(10):1459-67. doi: 10.1007/s00192-016-2956-1. Epub 2016 Feb 19. Review. — View Citation

Waddington H, Aloe AM, Becker BJ, Djimeu EW, Hombrados JG, Tugwell P, Wells G, Reeves B. Quasi-experimental study designs series-paper 6: risk of bias assessment. J Clin Epidemiol. 2017 Sep;89:43-52. doi: 10.1016/j.jclinepi.2017.02.015. Epub 2017 Mar 27. Review. — View Citation

Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13. Review. — View Citation

Zimmo K, Laine K, Vikanes Å, Fosse E, Zimmo M, Ali H, Thakar R, Sultan AH, Hassan S. Diagnosis and repair of perineal injuries: knowledge before and after expert training-a multicentre observational study among Palestinian physicians and midwives. BMJ Open. 2017 Apr 7;7(4):e014183. doi: 10.1136/bmjopen-2016-014183. — View Citation

* Note: There are 40 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the presence of pelvic floor injuries during childbirth after a Pilates Method program Decrease in the number of episiotomies and perineal tears Between the eighth and tenth day after birth
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