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

Perineal Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02588508
• Other study ID #: 0335932
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2015
• Last updated: November 18, 2015
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2015
• Source: Universidade Federal de Pernambuco
• Contact: Jânio N Alves, Graduate
• Phone: +55 83 999812006
• Email: janiourofisio[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a randomised controled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Perineal Tear

Intervention

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.
• 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".

Locations

Country	Name	City	State
Brazil	UFPernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (37)

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. Review. — View 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. — View 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. — View 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. — View Citation

Althabe F, Belizán JM, Bergel E. Episiotomy rates in primiparous women in Latin America: hospital based descriptive study. BMJ. 2002 Apr 20;324(7343):945-6. — View 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.

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. Review. Update in: Cochrane Database Syst Rev. 2013;4:CD005123. — View Citation

CARROLI, G.; BELIZAN, J. Episiotomy for vaginal birth (Review). n. 4, 2007

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.

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. — View 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. Epub 2007 Nov 26. — View 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. Epub 2012 Jun 12. — View 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. — View 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. Review. — View 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.

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. Review. — View 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. — View Citation

Helewa ME. Episiotomy and severe perineal trauma. Of science and fiction. CMAJ. 1997 Mar 15;156(6):811-3. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

Messelink B, Benson T, Berghmans B, Bø K, Corcos J, Fowler C, Laycock J, Lim PH, van Lunsen R, á 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. — View 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

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. Epub 2006 Mar 30. — View 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.

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. — View 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. Review. — View 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. Epub 2005 Mar 27. — View 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.

Scott JR. Episiotomy and vaginal trauma. Obstet Gynecol Clin North Am. 2005 Jun;32(2):307-21, x. Review. — View 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. — View 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.

ZANETTI, M. R. D. et al. Episiotomia : revendo conceitos. Femina, v. 37, n. 7, p. 5-9, 2009.

* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of suture	Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).	30 minutes	No
Secondary	Grade of perineal tear	Perineal tear ranked 1st, 2nd, 3rd and 4th degree	30 minutes	No
Secondary	perineal edema	Perineal edema is scored 0-4 (0 = no edema; 4 = edema invades the perineal body) .	1 hour	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Perineal tear	Number of participants with perineal tear after vaginal delivery (evaluated as yes or no).	30 minutes	No