NCT02588508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

October 26, 2015

Last Update Submit

November 18, 2015

Conditions

Perineal Tear

Keywords

perineal tearpainpelvic floorLabour

Outcome Measures

Primary Outcomes (1)

  • Need of suture

    Number of participants with perineal tear after vaginal delivery requiring suture (evaluated as yes or no).

    30 minutes

Secondary Outcomes (6)

  • Grade of perineal tear

    30 minutes

  • perineal edema

    1 hour

  • Perineal pain

    24 hours

  • Use of drugs for perineal pain

    24 hours

  • Satisfaction with the technique used

    24 hours

  • +1 more secondary outcomes

Study Arms (3)

Warm packs

EXPERIMENTAL

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

Perineal massage

EXPERIMENTAL

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

Hands off

NO INTERVENTION

Hands off group does not receive any perineal manipulation and they are only observed.

Interventions

Warm packsPROCEDURE

: The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.

Warm packs
Perineal massagePROCEDURE

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".

Perineal massage

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFPernambuco

Recife, Pernambuco, Brazil

RECRUITING

Related 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.

    PMID: 22161407BACKGROUND

  • 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.

    PMID: 16154062BACKGROUND

  • 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.

    PMID: 16732773BACKGROUND

  • 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.

    PMID: 17467591BACKGROUND

  • 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.

    PMID: 11964339BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16437520BACKGROUND

  • Carroli G, Belizan J. Episiotomy for vaginal birth. Cochrane Database Syst Rev. 2000;(2):CD000081. doi: 10.1002/14651858.CD000081.

    PMID: 10796120BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16504907BACKGROUND

  • 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.

    PMID: 18021143BACKGROUND

  • 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.

    PMID: 18031878BACKGROUND

  • 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;2011(8):CD008534. doi: 10.1002/14651858.CD008534.pub2.

    PMID: 21833968BACKGROUND

  • 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.

    PMID: 22691406BACKGROUND

  • FELICE, T.; SANTANA, L. Recursos fisioterapêuticos (crioterapia e termoterapia) na espasticidade: revisão de literatura. Rev Neurocienc, v. 17, n. 1, p. 57-62, 2009.

    BACKGROUND

  • 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.

    PMID: 9626426BACKGROUND

  • 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.

    PMID: 21614497BACKGROUND

  • Helewa ME. Episiotomy and severe perineal trauma. Of science and fiction. CMAJ. 1997 Mar 15;156(6):811-3. No abstract available.

    PMID: 9084387BACKGROUND

  • 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.

    PMID: 11004370BACKGROUND

  • 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.

    PMID: 8092203BACKGROUND

  • 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.

    PMID: 9065189BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 11251483BACKGROUND

  • 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.

    PMID: 15507941BACKGROUND

  • 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.

    PMID: 15977259BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 16579934BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20735499BACKGROUND

  • 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.

    PMID: 9767217BACKGROUND

  • 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.

    PMID: 15878430BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 15899363BACKGROUND

  • 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.

    PMID: 11375230BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline WS Ferreira, PHD

    Universidade Federal de Pernambuco

    STUDY DIRECTOR

Central Study Contacts

Jânio N Alves, Graduate

CONTACT

+55 83 999812006janiourofisio@gmail.com

Melania MR Amorim, PHD

CONTACT

+5583988221514melamorim@uol.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 27, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

BR(1)