Clinical trial NCT02582580: Effects of Antenatal Pelvic Floor Preparation Techniques for Childbirth
Official title: Effects of Perineal Massage, Vaginal Dilator and Pelvic Floor Muscles Training on the Perineal Integrity Primiparous: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pelvic floor
perineal trauma
physiotherapy
perineal integrity
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-10-21
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Perineal trauma during childbirth is an important etiological factor of various undesirable complications to women's health, with emphasis on pelvic floor dysfunction. Thus, methods that preserve the perineal integrity have been a challenge to practices among health professionals working in the gravid-puerperal cycle assistance. Despite the remarkable importance of beneficial effects of pelvic floor preparation prior to vaginal birth on prevention of perineal trauma, there are few studies in the literature that point which is the best method to be used to reduce the chances of perineal lesions. Therefore, there is need for more studies to compare existing methods. The objective this present study is to compare the effects of perineal massage, the vaginal dilator and training of the muscles of the pelvic floor to prepare the pelvic floor for vaginal birth on perineal integrity of primiparous. Primigravidae women are selected over 18 years, from the 32th gestational week and wishing to have a vaginal birth. Women will be randomly allocated into 3 groups: perineal massage, vaginal dilator and pelvic floor muscles training and should practice the technique from the 34th week of pregnancy until the time of delivery. All the women will be subject to clinical evaluation, functional assessment of pelvic floor and perineal integrity assessment prior to the beginning of the practice of the technique and between 45 and 60 days after childbirth.

Detailed description: METHODS:

Participants: Primigravidae women over 18 years old will be selected, from the 32th gestational week and wishing to have a vaginal delivery.

Interventions: Pregnant women will be randomly allocated into three groups: perineal massage, vaginal dilator and pelvic floor muscles training. The technique should be practiced from the 34th week of pregnancy until the beginning of labor. Randomization will be done by a researcher who was not involved with the recruitment, assessment and treatment of the participants. All participants will undergo a clinical and functional assessment of the pelvic floor before the beginning of the technique practice, as well as a reassessment of these items and an assessment of perineal integrity between 45 and 60 days after delivery for a blind physiotherapist regarding the interventional procedures.

Objective: To compare the effects of perineal massage, vaginal dilator and pelvic floor muscles training on the perineal integrity of primiparae women.

Outcome: The perineal integrity will be verified by the presence or absence of perineal laceration as well as their characteristics observed immediately after delivery.

Randomization: Participants randomization will be done from a sequence generated by a computer program.

Blinding: The evaluative procedures will be done by a 'blinded' physiotherapist in relation to the intervention procedures and the randomization procedure by a researcher who was not involved with the recruitment, evaluation and participant's treatment.

Discussion: The knowledge of the effects of antenatal pelvic floor preparation techniques on the perineal integrity and pelvic floor muscles function after delivery, will allow a better choice about which approach is the best to pregnant women to prevent perineal trauma.

Eligibility criteria: Inclusion Criteria:

* usual risk primigravidae women
* primigravidae women from the 32nd gestational week
* wishing to have a vaginal delivery

Exclusion Criteria:

* pregnant women with pelvic or vaginal surgeries
* presence of pelvic organ prolapse
* intolerance to vaginal palpation
* inability to contract the pelvic floor muscles
* vaginal infections
* neurological and/or cognitive impairments that prevent an understanding of the proposed procedures
* pregnant women who used antenatal pelvic floor methods of preparation prior to study enrollment

Primary outcomes:
measure: Perineal Perineal integrity assessed by the absence or presence of perineal lacerations
timeFrame: This assessment will be done until 60 days after delivery
Secondary outcomes:
measure: Function of the pelvic floor muscles evaluated by the PERFECT method
timeFrame: This assessment will be done at the time of initial evaluation (before the intervention) and between 45 and 60 days after delivery
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos - Physical therapy Department
state: São Paulo
Study officials:
affiliation: Federal University of São Carlos - Physiotherapy Department
name: Priscila G Alves
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aasheim V, Nilsen AB, Lukasse M, Reinar LM. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006672. doi: 10.1002/14651858.CD006672.pub2.
citation: Riesco MLG, Costa ASC, Almeida SFS, Basile ALO, Oliveira SMJV. Episiotomia, laceração e integridade perineal em partos normais: análise de fatores associados. Rev. Enferm. UERJ 2011; 19(1): 77-83.
citation: Shek KL, Chantarasorn V, Langer S, Phipps H, Dietz HP. Does the Epi-No Birth Trainer reduce levator trauma? A randomised controlled trial. Int Urogynecol J. 2011 Dec;22(12):1521-8. doi: 10.1007/s00192-011-1517-x. Epub 2011 Aug 2.
citation: 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.
citation: Oliveira LS, Brito LG, Quintana SM, Duarte G, Marcolin AC. Perineal trauma after vaginal delivery in healthy pregnant women. Sao Paulo Med J. 2014;132(4):231-8. doi: 10.1590/1516-3180.2014.1324710.
citation: Kovacs GT, Heath P, Heather C. First Australian trial of the birth-training device Epi-No: a highly significantly increased chance of an intact perineum. Aust N Z J Obstet Gynaecol. 2004 Aug;44(4):347-8. doi: 10.1111/j.1479-828X.2004.00265.x.
citation: Herbert J. Pregnancy and childbirth: the effects on pelvic floor muscles. Nurs Times. 2009 Feb 24-Mar 2;105(7):38-41.
citation: Foroughipour A, Firuzeh F, Ghahiri A, Norbakhsh V, Heidari T. The effect of perineal control with hands-on and hand-poised methods on perineal trauma and delivery outcome. J Res Med Sci. 2011 Aug;16(8):1040-6.
citation: Kopas ML. A review of evidence-based practices for management of the second stage of labor. J Midwifery Womens Health. 2014 May-Jun;59(3):264-76. doi: 10.1111/jmwh.12199.
citation: Zhou F, Wang XD, Li J, Huang GQ, Gao BX. Hyaluronidase for reducing perineal trauma. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD010441. doi: 10.1002/14651858.CD010441.pub2.
citation: Brito LG, Ferreira CH, Duarte G, Nogueira AA, Marcolin AC. Antepartum use of Epi-No birth trainer for preventing perineal trauma: systematic review. Int Urogynecol J. 2015 Oct;26(10):1429-36. doi: 10.1007/s00192-015-2687-8. Epub 2015 Apr 8.
citation: Du Y, Xu L, Ding L, Wang Y, Wang Z. The effect of antenatal pelvic floor muscle training on labor and delivery outcomes: a systematic review with meta-analysis. Int Urogynecol J. 2015 Oct;26(10):1415-27. doi: 10.1007/s00192-015-2654-4. Epub 2015 Feb 25.
citation: Salvesen KA, Morkved S. Randomised controlled trial of pelvic floor muscle training during pregnancy. BMJ. 2004 Aug 14;329(7462):378-80. doi: 10.1136/bmj.38163.724306.3A. Epub 2004 Jul 14.
citation: Agur W, Steggles P, Waterfield M, Freeman R. Does antenatal pelvic floor muscle training affect the outcome of labour? A randomised controlled trial. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jan;19(1):85-8. doi: 10.1007/s00192-007-0391-z. Epub 2007 May 26.
citation: Bo K, Fleten C, Nystad W. Effect of antenatal pelvic floor muscle training on labor and birth. Obstet Gynecol. 2009 Jun;113(6):1279-1284. doi: 10.1097/AOG.0b013e3181a66f40.
citation: Dias LA, Driusso P, Aita DL, Quintana SM, Bo K, Ferreira CH. Effect of pelvic floor muscle training on labour and newborn outcomes: a randomized controlled trial. Rev Bras Fisioter. 2011 Nov-Dec;15(6):487-93. doi: 10.1590/s1413-35552011005000011. Epub 2011 Aug 19.
citation: Bo K, Hilde G, Jensen JS, Siafarikas F, Engh ME. Too tight to give birth? Assessment of pelvic floor muscle function in 277 nulliparous pregnant women. Int Urogynecol J. 2013 Dec;24(12):2065-70. doi: 10.1007/s00192-013-2133-8. Epub 2013 Jun 8.
citation: Boyle R, Hay-Smith EJ, Cody JD, Morkved S. Pelvic floor muscle training for prevention and treatment of urinary and fecal incontinence in antenatal and postnatal women: a short version Cochrane review. Neurourol Urodyn. 2014 Mar;33(3):269-76. doi: 10.1002/nau.22402. Epub 2013 Apr 24.
citation: Dönmez S, Kavlak O. Effects of prenatal perineal massage and Kegel exercises on the integrity of postnatal perine. Health 2015; 7: 495-505.
citation: Nagib ABL, Guirro ECO, Palauro VA, Guirro RRJ. Avaliação da sinergia da musculatura abdomino-pélvica em nulíparas com eletromiografia e biofeedback perineal. RBGO 2005; 27(4): 210-5.
citation: Laycock J, Jerwood D. Pelvic floor muscle assessment: the PERFECT scheme. Physiotherapy 2001; 87(12): 631-42.
citation: Moreira ECH, Brunetto AF, Catanho MM, Nakagawa TH, Yamaguti WPS. Estudo da ação sinérgica dos músculos respiratórios e do assoalho pélvico. Rev Bras Fisioter. 2002; 6(2): 71-6.
citation: Labrecque M, Eason E, Marcoux S, Lemieux F, Pinault JJ, Feldman P, Laperriere L. Randomized controlled trial of prevention of perineal trauma by perineal massage during pregnancy. Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):593-600. doi: 10.1016/s0002-9378(99)70260-7.
citation: Bodner-Adler B, Bodner K, Mayerhofer K. Perineal massage during pregnancy in primiparous women. Int J Gynaecol Obstet. 2002 Jul;78(1):51-3. doi: 10.1016/s0020-7292(02)00065-6. No abstract available.
citation: Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available.
citation: Jones LE, Marsden N. The application of antenatal perineal massage: a review of literature to determine instruction, dosage and technique. Spring 2008; 102: 8-11.
citation: Mei-dan E, Walfisch A, Raz I, Levy A, Hallak M. Perineal massage during pregnancy: a prospective controlled trial. Isr Med Assoc J. 2008 Jul;10(7):499-502.
citation: Hillebrenner J, Wagenpfeil S, Schuchardt R, Schelling M, Schneider KT. [Initial experiences with primiparous women using a new kind of Epi-no labor trainer]. Z Geburtshilfe Neonatol. 2001 Jan-Feb;205(1):12-9. doi: 10.1055/s-2001-14552. German.
citation: Kok J, Tan KH, Koh S, Cheng PS, Lim WY, Yew ML, Yeo GS. Antenatal use of a novel vaginal birth training device by term primiparous women in Singapore. Singapore Med J. 2004 Jul;45(7):318-23.
citation: Ruckhaberle E, Jundt K, Bauerle M, Brisch KH, Ulm K, Dannecker C, Schneider KT. Prospective randomised multicentre trial with the birth trainer EPI-NO for the prevention of perineal trauma. Aust N Z J Obstet Gynaecol. 2009 Oct;49(5):478-83. doi: 10.1111/j.1479-828X.2009.01044.x.
citation: Ashton-Miller JA, Delancey JO. On the biomechanics of vaginal birth and common sequelae. Annu Rev Biomed Eng. 2009;11:163-76. doi: 10.1146/annurev-bioeng-061008-124823.
citation: Ferreira M, Santos P. Princípios da fisiologia do exercício no treino dos músculos do pavimento pélvico. Acta Urológica 2009; 26(3): 31-8.
citation: Pereira LC, Botelho S, Marques J, Amorim CF, Lanza AH, Palma P, Riccetto C. Are transversus abdominis/oblique internal and pelvic floor muscles coactivated during pregnancy and postpartum? Neurourol Urodyn. 2013 Jun;32(5):416-9. doi: 10.1002/nau.22315. Epub 2012 Oct 15.
citation: Leite JS. Caracterização das lacerações perineais espontâneas no parto normal. http://www.teses.usp.br/teses/disponiveis/7/7141/tde-20022013-151836/pt-br (2012). Acessado em 08 Jun 2015.
citation: Caroci AS, Riesco MLG, Leite JS, Araíjo NM, Scarabotto LB,Oliveira SMJV. Localização das lacerações perineais no parto normal em mulheres primíparas. Rev enferm UERJ 2014; 22(3): 402-8.
citation: Cunningham FG. et al. Conduta no trabalho de parto e parto normal. In: Williams Obstetrícia. 20a Ed. Rio de Janeiro: Guanabara Koogan, p. 281-298, 2000.
citation: Kettle C, Dowswell T, Ismail KM. Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD000947. doi: 10.1002/14651858.CD000947.pub3.
citation: Kettle C, Dowswell T, Ismail KM. Absorbable suture materials for primary repair of episiotomy and second degree tears. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD000006. doi: 10.1002/14651858.CD000006.pub2.
citation: Elharmeel SM, Chaudhary Y, Tan S, Scheermeyer E, Hanafy A, van Driel ML. Surgical repair of spontaneous perineal tears that occur during childbirth versus no intervention. Cochrane Database Syst Rev. 2011 Aug 10;(8):CD008534. doi: 10.1002/14651858.CD008534.pub2.
citation: Parente MP, Natal Jorge RM, Mascarenhas T, Silva-Filho AL. The influence of pelvic muscle activation during vaginal delivery. Obstet Gynecol. 2010 Apr;115(4):804-808. doi: 10.1097/AOG.0b013e3181d534cd.
citation: McHugh MP, Cosgrave CH. To stretch or not to stretch: the role of stretching in injury prevention and performance. Scand J Med Sci Sports. 2010 Apr;20(2):169-81. doi: 10.1111/j.1600-0838.2009.01058.x. Epub 2009 Dec 18.
citation: Kruger JA, Dietz HP, Murphy BA. Pelvic floor function in elite nulliparous athletes. Ultrasound Obstet Gynecol. 2007 Jul;30(1):81-5. doi: 10.1002/uog.4027.