Advertisement

International Urogynecology Journal

, Volume 29, Issue 10, pp 1485–1492 | Cite as

Prospective evaluation of the safety and feasibility of a pelvic floor dilator during active labor

  • Francisco J. Orejuela
  • Rajshi Gandhi
  • Lauren Mack
  • Wesley Lee
  • Haleh Sangi-Haghpeykar
  • Hans P. Dietz
  • Susan M. Ramin
Original Article

Abstract

Introduction and hypothesis

The objective was to assess the safety and feasibility of using a pelvic floor dilator during active labor to prevent injuries to the levator ani muscle (LAM) and perineum.

Methods

In a prospective pilot study, a pelvic floor dilator using soft pads was introduced into the vaginal canal to gradually expand the vagina, in 30 nulliparous women and in 10 controls. The primary outcomes were adverse events related to the device. Secondary outcomes were perineal lacerations after delivery, sonographically defined levator ani injury, hiatal area dimensions, and anal sphincter disruption, all at 12–20 weeks postpartum, and maximum pelvic floor dilation, time to achieve maximum dilation, and device retention rate.

Results

From October 2014 through November 2016, a total of 494 women were screened, and 61 consented to the study. Thirty women used the device and 27 returned for follow-up. No maternal or neonatal injuries were related to use of the dilator. The average maximum dilation of the vaginal canal was 7.4 cm (SD 0.7, range 5.5–8.0). Dilation time averaged 27 min (SD 13, range 5–60). Device insertion adjustment was needed in 13 out of 30 cases (43%). Similar rates of 3th–4th degree perineal lacerations were seen in both groups. Levator ani avulsion was diagnosed in 2 out of 27 (7%) in the device group and in 1 out of 9 (11%) in the control group (p = 0.2). The rate of partial injury in the device group was 2 out of 27 (7%) vs 2 out of 9 (22%) in the comparison group (p = 0.2).

Conclusion

The use of the pelvic floor dilator during active labor is feasible. No safety issues were identified.

Keywords

Levator avulsion Pelvic floor trauma prevention 

Notes

Funding

Materna Medical Inc., Mountain View, CA, USA (salaries and supplies).

Compliance with ethical standards

Conflicts of interest

FJ Orejuela and SM Ramin received salary support from Materna Medical Inc.

HP Dietz receives unrestricted educational grant support from GE.

None of the other authors has any conflicts of interest to disclose.

Supplementary material

192_2018_3555_MOESM1_ESM.mov (108.2 mb)
ESM 1 (MOV 110808 kb)

References

  1. 1.
    Gyhagen M, Bullarbo M, Nielsen TF, Milsom I. Prevalence and risk factors for pelvic organ prolapse 20 years after childbirth: a national cohort study in singleton primiparae after vaginal or caesarean delivery. BJOG. 2013;120(2):152–60.  https://doi.org/10.1111/1471-0528.12020.CrossRefPubMedGoogle Scholar
  2. 2.
    Goldberg J, Hyslop T, Tolosa JE, Sultana C. Racial differences in severe perineal lacerations after vaginal delivery. Am J Obstet Gynecol. 2003;188(4):1063–7.CrossRefGoogle Scholar
  3. 3.
    Dietz HP. Pelvic floor trauma following vaginal delivery. Curr Opin Obstet Gynecol. 2006;18(5):528–37.  https://doi.org/10.1097/01.gco.0000242956.40491.1e.CrossRefPubMedGoogle Scholar
  4. 4.
    Handa VL, Blomquist JL, Knoepp LR, Hoskey KA, McDermott KC, Munoz A. Pelvic floor disorders 5–10 years after vaginal or cesarean childbirth. Obstet Gynecol. 2011;118(4):777–84.  https://doi.org/10.1097/AOG.0b013e3182267f2f.CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311–6.  https://doi.org/10.1001/jama.300.11.1311.CrossRefPubMedPubMedCentralGoogle Scholar
  6. 6.
    Wu JM, Matthews CA, Conover MM, Pate V, Jonsson FM. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201–6.  https://doi.org/10.1097/aog.0000000000000286.CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Dudding TC, Vaizey CJ, Kamm MA. Obstetric anal sphincter injury: incidence, risk factors, and management. Ann Surg. 2008;247(2):224–37.  https://doi.org/10.1097/SLA.0b013e318142cdf4.CrossRefPubMedGoogle Scholar
  8. 8.
    Riskin-Mashiah S, O'Brian Smith E, Wilkins IA. Risk factors for severe perineal tear: can we do better? Am J Perinatol. 2002;19(5):225–34.  https://doi.org/10.1055/s-2002-33088.CrossRefPubMedGoogle Scholar
  9. 9.
    LaCross A, Groff M, Smaldone A. Obstetric anal sphincter injury and anal incontinence following vaginal birth: a systematic review and meta-analysis. J Midwifery Womens Health. 2015;60(1):37–47.  https://doi.org/10.1111/jmwh.12283.CrossRefPubMedGoogle Scholar
  10. 10.
    DeLancey JO, Kearney R, Chou Q, Speights S, Binno S. The appearance of levator ani muscle abnormalities in magnetic resonance images after vaginal delivery. Obstet Gynecol. 2003;101(1):46–53.PubMedPubMedCentralGoogle Scholar
  11. 11.
    Dietz HP, Lanzarone V. Levator trauma after vaginal delivery. Obstet Gynecol. 2005;106(4):707–12.  https://doi.org/10.1097/01.aog.0000178779.62181.01.CrossRefPubMedGoogle Scholar
  12. 12.
    Schwertner-Tiepelmann N, Thakar R, Sultan AH, Tunn R. Obstetric levator ani muscle injuries: current status. Ultrasound Obstet Gynecol. 2012;39(4):372–83.  https://doi.org/10.1002/uog.11080.CrossRefPubMedGoogle Scholar
  13. 13.
    Lien KC, Mooney B, DeLancey JO, Ashton-Miller JA. Levator ani muscle stretch induced by simulated vaginal birth. Obstet Gynecol. 2004;103(1):31–40.  https://doi.org/10.1097/01.aog.0000109207.22354.65.CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Ashton-Miller JA, Delancey JO. On the biomechanics of vaginal birth and common sequelae. Annu Rev Biomed Eng. 2009;11:163–76.  https://doi.org/10.1146/annurev-bioeng-061008-124823.CrossRefPubMedPubMedCentralGoogle Scholar
  15. 15.
    Svabik K, Shek KL, Dietz HP. How much does the levator hiatus have to stretch during childbirth? BJOG. 2009;116(12):1657–62.  https://doi.org/10.1111/j.1471-0528.2009.02321.x.CrossRefPubMedGoogle Scholar
  16. 16.
    Kamisan Atan I, Shek KL, Langer S, Guzman Rojas R, Caudwell-Hall J, Daly JO, et al. Does the Epi-No® birth trainer prevent vaginal birth-related pelvic floor trauma? A multicentre prospective randomised controlled trial. BJOG. 2016;123(6):995–1003.  https://doi.org/10.1111/1471-0528.13924.CrossRefPubMedGoogle Scholar
  17. 17.
    Beckmann MM, Stock OM. Antenatal perineal massage for reducing perineal trauma. Cochrane Database Syst Rev 2013;(4):CD005123.  https://doi.org/10.1002/14651858.CD005123.pub3.
  18. 18.
    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;(12):CD006672.  https://doi.org/10.1002/14651858.CD006672.pub2.
  19. 19.
    Bazi T, Takahashi S, Ismail S, Bo K, Ruiz-Zapata AM, Duckett J, et al. Prevention of pelvic floor disorders: International Urogynecological Association research and development committee opinion. Int Urogynecol J. 2016;27(12):1785–95.  https://doi.org/10.1007/s00192-016-2993-9.CrossRefPubMedGoogle Scholar
  20. 20.
    Practice Bulletin No. 165: Prevention and management of obstetric lacerations at vaginal delivery. Obstet Gynecol. 2016;128(1):e1–15.  https://doi.org/10.1097/aog.0000000000001523.
  21. 21.
    Dietz HP, Shek KL. Tomographic ultrasound imaging of the pelvic floor: which levels matter most? Ultrasound Obstet Gynecol. 2009;33(6):698–703.  https://doi.org/10.1002/uog.6403.CrossRefPubMedGoogle Scholar
  22. 22.
    Dietz HP, Haylen BT, Broome J. Ultrasound in the quantification of female pelvic organ prolapse. Ultrasound Obstet Gynecol. 2001;18(5):511–4.  https://doi.org/10.1046/j.0960-7692.2001.00494.x.CrossRefPubMedGoogle Scholar
  23. 23.
    Guzman Rojas RA, Kamisan Atan I, Shek KL, Dietz HP. Anal sphincter trauma and anal incontinence in urogynecological patients. Ultrasound Obstet Gynecol. 2015;46(3):363–6.  https://doi.org/10.1002/uog.14845.CrossRefPubMedGoogle Scholar
  24. 24.
    Kearney R, Miller JM, Ashton-Miller JA, DeLancey JO. Obstetric factors associated with levator ani muscle injury after vaginal birth. Obstet Gynecol. 2006;107(1):144–9.  https://doi.org/10.1097/01.AOG.0000194063.63206.1c.CrossRefPubMedPubMedCentralGoogle Scholar
  25. 25.
    Caudwell-Hall J, Kamisan Atan I, Martin A, Guzman Rojas R, Langer S, Shek K, et al. Intrapartum predictors of maternal levator ani injury. Acta Obstet Gynecol Scand. 2017;96(4):426–31.  https://doi.org/10.1111/aogs.13103.CrossRefPubMedGoogle Scholar

Copyright information

© The International Urogynecological Association 2018

Authors and Affiliations

  1. 1.Department of Obstetrics and GynecologyBaylor College of Medicine and Texas Children’s Hospital Pavilion for WomenHoustonUSA
  2. 2.Department of Obstetrics and Gynecology, Sydney Medical School NepeanThe University of SydneySydneyAustralia

Personalised recommendations