Clinical trial NCT02588508: Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.
Official title: Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perineal Tear
Keywords: perineal tear
pain
pelvic floor
Labour
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 201
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of warm packs, perineal massage and hands off, during labour, in the perineal outcomes. The perineal outcomes are perineal tears, grade of perineal tears, need of suture, perineal edema, perineal pain, use of drugs for perineal pain, and satisfaction with the technique used.

Detailed description: This study is a randomised controled trial.

Eligibility criteria: Inclusion Criteria:

* parturient in active phase of labour
* single fetus at term (37-42 weeks)
* bent cephalic fetal presentation
* parity less than four children

Exclusion Criteria:

* use any perineal preparation techniques during pregnancy
* clinical indication for caesarean section

Primary outcomes:
measure: Need of suture
timeFrame: 30 minutes
Secondary outcomes:
measure: Grade of perineal tear
timeFrame: 30 minutes
measure: perineal edema
timeFrame: 1 hour
measure: Perineal pain
timeFrame: 24 hours
measure: Use of drugs for perineal pain
timeFrame: 24 hours
measure: Satisfaction with the technique used
timeFrame: 24 hours
measure: Perineal tear
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: UFPernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Caroline WS Ferreira, PHD
role: STUDY_DIRECTOR
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: Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. J Midwifery Womens Health. 2005 Sep-Oct;50(5):365-72. doi: 10.1016/j.jmwh.2005.05.012.
citation: Albers LL, Sedler KD, Bedrick EJ, Teaf D, Peralta P. Factors related to genital tract trauma in normal spontaneous vaginal births. Birth. 2006 Jun;33(2):94-100. doi: 10.1111/j.0730-7659.2006.00085.x.
citation: Albers LL, Borders N. Minimizing genital tract trauma and related pain following spontaneous vaginal birth. J Midwifery Womens Health. 2007 May-Jun;52(3):246-53. doi: 10.1016/j.jmwh.2006.12.008.
citation: Althabe F, Belizan JM, Bergel E. Episiotomy rates in primiparous women in Latin America: hospital based descriptive study. BMJ. 2002 Apr 20;324(7343):945-6. doi: 10.1136/bmj.324.7343.945. No abstract available.
citation: AMORIM, M. M. R. DE et al. Assistência humanizada ao parto no Instituto de Saúde Elpídio de Almeida (ISEA): resultados maternos. Revista Saúde & Ciência, v. v. I, n. n. 1, p. 80 - 7, 2010.
citation: AMORIM, M. M. R. DE; PORTO, A. M. F.; SOUZA, A. S. R. Assistência ao segundo e terceiro períodos do trabalho de parto baseada em evidências. Femina, v. 38, n. 11, p. 583-91, 2010.
citation: Beckmann MM, Garrett AJ. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005123. doi: 10.1002/14651858.CD005123.pub2.
citation: CARROLI, G.; BELIZAN, J. Episiotomy for vaginal birth (Review). n. 4, 2007
citation: COELHO, L. F. S. O treino de flexibilidade muscular e o aumento da amplitude de movimento: uma revisão crítica da literatura. Revista de Desporto e Saúde, v. 4, n. 3, p. 61-72, 2007.
citation: de Souza Caroci da Costa A, Gonzalez Riesco ML. A comparison of "hands off" versus "hands on" techniques for decreasing perineal lacerations during birth. J Midwifery Womens Health. 2006 Mar-Apr;51(2):106-11. doi: 10.1016/j.jmwh.2005.10.017.
citation: Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn R, Brodrick B. Perineal outcomes and maternal comfort related to the application of perineal warm packs in the second stage of labor: a randomized controlled trial. Birth. 2007 Dec;34(4):282-90. doi: 10.1111/j.1523-536X.2007.00186.x.
citation: Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery. 2009 Apr;25(2):e39-48. doi: 10.1016/j.midw.2007.08.002. Epub 2007 Nov 26.
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: Dahlen HG. Perineal warm compress reduces risk of third- and fourth- degree tears and should be part of second stage care. Evid Based Nurs. 2012 Oct;15(4):103-4. doi: 10.1136/ebnurs-2012-100685. Epub 2012 Jun 12. No abstract available.
citation: FELICE, T.; SANTANA, L. Recursos fisioterapêuticos (crioterapia e termoterapia) na espasticidade: revisão de literatura. Rev Neurocienc, v. 17, n. 1, p. 57-62, 2009.
citation: Flynn P, Franiek J, Janssen P, Hannah WJ, Klein MC. How can second-stage management prevent perineal trauma? Critical review. Can Fam Physician. 1997 Jan;43:73-84.
citation: Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.
citation: Helewa ME. Episiotomy and severe perineal trauma. Of science and fiction. CMAJ. 1997 Mar 15;156(6):811-3. No abstract available.
citation: Howard D, Davies PS, DeLancey JO, Small Y. Differences in perineal lacerations in black and white primiparas. Obstet Gynecol. 2000 Oct;96(4):622-4. doi: 10.1016/s0029-7844(00)00956-x.
citation: Klein MC, Gauthier RJ, Robbins JM, Kaczorowski J, Jorgensen SH, Franco ED, Johnson B, Waghorn K, Gelfand MM, Guralnick MS, et al. Relationship of episiotomy to perineal trauma and morbidity, sexual dysfunction, and pelvic floor relaxation. Am J Obstet Gynecol. 1994 Sep;171(3):591-8. doi: 10.1016/0002-9378(94)90070-1.
citation: Klein MC, Janssen PA, MacWilliam L, Kaczorowski J, Johnson B. Determinants of vaginal-perineal integrity and pelvic floor functioning in childbirth. Am J Obstet Gynecol. 1997 Feb;176(2):403-10. doi: 10.1016/s0002-9378(97)70506-4.
citation: LEAL, N. V et al. Factors associated with perineal lacerations requiring suture in vaginal births without episiotomy. Obstetrics and gynecology, v. 123 Suppl , p. 63S-4S, maio 2014.
citation: Lundquist M, Olsson A, Nissen E, Norman M. Is it necessary to suture all lacerations after a vaginal delivery? Birth. 2000 Jun;27(2):79-85. doi: 10.1046/j.1523-536x.2000.00079.x.
citation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
citation: Messelink B, Benson T, Berghmans B, Bo K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, a Nijeholt GL, Pemberton J, Wang A, Watier A, Van Kerrebroeck P. Standardization of terminology of pelvic floor muscle function and dysfunction: report from the pelvic floor clinical assessment group of the International Continence Society. Neurourol Urodyn. 2005;24(4):374-80. doi: 10.1002/nau.20144. No abstract available.
citation: OMS. Integrated management of pregnancy and childbirth. Manejo de las complicaciones del embarazo e el parto: Guía para obstetrices y médicos. OMS ed. Ginebra: [s.n.]. p. 438
citation: Patel DA, Xu X, Thomason AD, Ransom SB, Ivy JS, DeLancey JO. Childbirth and pelvic floor dysfunction: an epidemiologic approach to the assessment of prevention opportunities at delivery. Am J Obstet Gynecol. 2006 Jul;195(1):23-8. doi: 10.1016/j.ajog.2006.01.042. Epub 2006 Mar 30.
citation: PHILLIPS, C.; MONGA, A. Childbirth and the pelvic floor: "the gynaecological consequences."Reviews in Gynaecological Practice, v. 5, n. 1, p. 15-22, mar. 2005.
citation: Rathfisch G, Dikencik BK, Kizilkaya Beji N, Comert N, Tekirdag AI, Kadioglu A. Effects of perineal trauma on postpartum sexual function. J Adv Nurs. 2010 Dec;66(12):2640-9. doi: 10.1111/j.1365-2648.2010.05428.x. Epub 2010 Aug 23.
citation: Renfrew MJ, Hannah W, Albers L, Floyd E. Practices that minimize trauma to the genital tract in childbirth: a systematic review of the literature. Birth. 1998 Sep;25(3):143-60. doi: 10.1111/j.1523-536x.1998.t01-2-.x.
citation: Sanders J, Peters TJ, Campbell R. Techniques to reduce perineal pain during spontaneous vaginal delivery and perineal suturing: a UK survey of midwifery practice. Midwifery. 2005 Jun;21(2):154-60. doi: 10.1016/j.midw.2004.12.003. Epub 2005 Mar 27.
citation: SANTOS, J. DE O. et al. Freqüência de traumas perineais nos partos vaginais. Esc Anna Nery Rev Enferm, v. 12, n. 4, p. 658-63, 2008.
citation: Scott JR. Episiotomy and vaginal trauma. Obstet Gynecol Clin North Am. 2005 Jun;32(2):307-21, x. doi: 10.1016/j.ogc.2004.12.001.
citation: Stamp G, Kruzins G, Crowther C. Perineal massage in labour and prevention of perineal trauma: randomised controlled trial. BMJ. 2001 May 26;322(7297):1277-80. doi: 10.1136/bmj.322.7297.1277.
citation: TORRES, I. M. Efetividade da crioterapia para o controle da dor perineal no pós-parto vaginal imediato: ensaio clínico randomizado. 2013. Dissertação (Mestrado em Saúde Materno-Infantil). Instituto de Medicina Integral Professor Fernando Figueira, Recife, 2013.
citation: ZANETTI, M. R. D. et al. Episiotomia : revendo conceitos. Femina, v. 37, n. 7, p. 5-9, 2009.