Effectiveness of Warm Packs, Perineal Massage and Hands Off During Labour in the Perineal Outcomes.

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.

Study Overview

• Status: Unknown
• Conditions: Perineal Tear
• Intervention / Treatment: Procedure: Warm packs; Procedure: Perineal massage

Detailed Description

This study is a randomised controled trial.

• Study Type: Interventional
• Enrollment (Anticipated): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • Recruiting
      • UFPernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm packs; The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.	Procedure: Warm packs; : The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.
Experimental: Perineal massage; The perineal massage will be gently held in the longitudinal direction of the muscle fibers, with movements of the thumb and forefinger, like "count coins".	Procedure: Perineal massage; The perineal massage will be gently held in the longitudinal direction of the muscle fibers, with movements of the thumb and forefinger, like "count coins".
No Intervention: Hands off; Hands off group does not receive any perineal manipulation and they are only observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of suture	Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of perineal tear	Perineal tear ranked 1st, 2nd, 3rd and 4th degree	30 minutes
perineal edema	Perineal edema is scored 0-4 (0 = no edema; 4 = edema invades the perineal body) .	1 hour
Perineal pain	self reported ´perineal pain intensity. Perineal pain is scored 0-10 (0 = no pain; 10 = pain as bad as can be).	24 hours
Use of drugs for perineal pain	Number of participants using drugs for perineal pain at the time of 24 hours after vaginal delivery (evaluated as yes or no).	24 hours
Satisfaction with the technique used	Satisfaction of the woman with the technique used for perineal care. Satisfaction is scored 0-4 (0 = very satisfied; 4 = very dissatisfied)	24 hours
Perineal tear	Number of participants with perineal tear after vaginal delivery (evaluated as yes or no).	30 minutes

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Study Director: Caroline WS Ferreira, PHD, Universidade Federal de Pernambuco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Carroli G, Belizan J, Stamp G. Episiotomy for vaginal birth. Birth. 1999 Dec;26(4):263. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• FELICE, T.; SANTANA, L. Recursos fisioterapêuticos (crioterapia e termoterapia) na espasticidade: revisão de literatura. Rev Neurocienc, v. 17, n. 1, p. 57-62, 2009.
• 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.
• 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.
• Helewa ME. Episiotomy and severe perineal trauma. Of science and fiction. CMAJ. 1997 Mar 15;156(6):811-3. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• ZANETTI, M. R. D. et al. Episiotomia : revendo conceitos. Femina, v. 37, n. 7, p. 5-9, 2009.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: pain; perineal tear; pelvic floor; Labour
• Other Study ID Numbers: 0335932