A randomized control trial of platelet-rich plasma in supporting the recovery of postpartum levator ani muscle trauma

  • Fernandi Moegni Doctoral Programme in Medical Sciences, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Department of Obstetric and Gynecology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia https://orcid.org/0000-0001-9537-4256
  • Andhika Rachman Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
  • Ermita Ibrahim Ilyas Department of Physiology and Biophysics, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
  • Alida Harahap Doctoral Programme in Medical Sciences, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
  • Trika Irianta Department of Obstetric and Gynecology, Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia
  • Ferry Hidayat Department of Obstetric and Gynecology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
  • Dwiana Ocviyanti Department of Obstetric and Gynecology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
  • Budi Iman Santoso Department of Obstetric and Gynecology, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia
Keywords: obstetric labor complication, parturition, pelvic floor disorder, platelet-rich plasma, randomized controlled trial
Abstract viewed: 154 times
PDF downloaded: 115 times
HTML downloaded: 29 times
EPUB downloaded: 41 times

Abstract

BACKGROUND Pelvic floor dysfunction (PFD) is mostly caused by childbirth levator ani muscle (LAM) trauma. We hypothesized that platelet-rich plasma (PRP) therapy could support the recovery of LAM in postpartum trauma.

METHODS A prospective, single-blind, randomized control study was enrolled in primigravid women from November 2016 to July 2019 at 21 health facilities in Jakarta, Indonesia. Subjects were injected with autologous PRP or placebo at LAM during perineorrhaphy after childbirth. The primary outcome was regaining LAM strength and reducing levator hiatal area at 3 months postpartum. The LAM strength was examined by perineometer (cmH₂O), and levator hiatal area was examined by transperineal ultrasound (cm²) at antenatal and 3 months after delivery. Mann–Whitney U test and Wilcoxon signed-rank test were used for analysis. The study was registered in clinicaltrials.gov: NCT03021954.

RESULTS Among 240 women, 58 were eligible for analysis. There were no differences in LAM strength and levator ani hiatal area at 3 months postpartum between the two groups (p = 0.583 and p = 0.185, respectively).

CONCLUSIONS PRP therapy did not show a difference in the muscle recovery healing process.

References

  1. Pangastuti N, Sari DC, Santoso BI, Agustiningsih D, Emilia O. [Risk factors for pelvic organ prolapse in women with history of vaginal delivery in Yogyakarta]. Maj Kedokt Bandung. 2018;50(2):102-8. Indonesian. https://doi.org/10.15395/mkb.v50n2.1321

  2. Davila GW, Ghoniem GM, Wexner SD, editors. Pelvic floor dysfunction: a multidisciplinary approach. London: Springer; 2006. https://doi.org/10.1007/b136174

  3. Dietz HP, Franco AV, Shek KL, Kirby A. Avulsion injury and levator hiatal ballooning: two independent risk factors for prolapse? An observational study. Acta Obstet Gynecol Scand. 2012;91(2):211-4. https://doi.org/10.1111/j.1600-0412.2011.01315.x

  4. Fakhrizal E, Priyatini T, Santoso BI, Junizaf J, Moegni F, Djusad S, et al. Prevalence and risk factors of persistent stress urinary incontinence at three months postpartum in Indonesian women. Med J Indones. 2016;25(3):163-70. https://doi.org/10.13181/mji.v25i3.1407

  5. Sénat MV, Sentilhes L, Battut A, Benhamou D, Bydlowski S, Chantry A, et al. Postpartum practice: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2016;202:1-8. https://doi.org/10.1016/j.ejogrb.2016.04.032

  6. Wroblewski AP, Mejia HA, Wright VJ. Application of platelet-rich plasma to enhance tissue repair. Oper Tech Orthop. 2010;20(2):98-105. https://doi.org/10.1053/j.oto.2009.10.006

  7. Dhurat R, Sukesh M. Principles and methods of preparation of platelet-rich plasma: a review and author's perspective. J Cutan Aesthet Surg. 2014;7(4):189-97. https://doi.org/10.4103/0974-2077.150734

  8. Rossi LA, Molina Rómoli AR, Bertona Altieri BA, Burgos Flor JA, Scordo WE, Elizondo CM. Does platelet-rich plasma decrease time to return to sports in acute muscle tear? A randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017;25(10):3319-25. https://doi.org/10.1007/s00167-016-4129-7

  9. Atılgan AE, Aydın A. Cystocele repair with platelet-rich plasma. Indian J Surg. 2021;83:726-30. https://doi.org/10.1007/s12262-020-02459-6

  10. Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15:264. https://doi.org/10.1186/1745-6215-15-264

  11. Lana JF, Huber SC, Purita J, Tambeli CH, Santos GS, Paulus C, et al. Leukocyte-rich PRP versus leukocyte-poor PRP - The role of monocyte/macrophage function in the healing cascade. J Clin Orthop Trauma. 2019;10(Suppl 1):S7-12. https://doi.org/10.1016/j.jcot.2019.05.008

  12. Karina K, Ekaputri K, Biben JA, Purwoko RH, Sibuea TP, Astuti SL, et al. Evaluating the safety of intravenous delivery of autologous activated platelet-rich plasma. J Health Sci. 2021;11(2):61-5. https://doi.org/10.17532/jhsci.2021.1276

  13. Dietz HP. Pelvic floor muscle trauma. Expert Rev Obstet Gynecol. 2010;5(4):479-92. https://doi.org/10.1586/eog.10.28

  14. Memon HU, Blomquist JL, Dietz HP, Pierce CB, Weinstein MM, Handa VL. Comparison of levator ani muscle avulsion injury after forceps-assisted and vacuum-assisted vaginal childbirth. Obstet Gynecol. 2015;125(5):1080-7. https://doi.org/10.1097/AOG.0000000000000825

  15. Shek KL, Chantarasorn V, Langer S, Dietz HP. Does levator trauma 'heal'? Ultrasound Obstet Gynecol. 2012;40(5):570-5. https://doi.org/10.1002/uog.11203

  16. Schüssler B, Laycock J, Norton PA, Stanton SL. Pelvic floor re-education: principles and Practice. 1st ed. London: Springer; 1994. p. 190. https://doi.org/10.1007/978-1-4471-3569-2_1

  17. Trevisson B, Becerro-de-Bengoa-Vallejo R, Sevillano D, González N, Losa-Iglesias M, López-López D, et al. Age-based inter-subject variability in platelet and white blood cell concentrations of platelet-rich plasma prepared using a new application to blood separation system. Int Wound J. 2022;19(2):362-9. https://doi.org/10.1111/iwj.13636

  18. van Veelen GA, Schweitzer KJ, van der Vaart CH. Ultrasound imaging of the pelvic floor: changes in anatomy during and after first pregnancy. Ultrasound Obstet Gynecol. 2014;44(4):476-80. https://doi.org/10.1002/uog.13301

  19. Petros P. The female pelvic floor: unction, dysfunction and management according to the integral theory. 2nd ed. Germany: Springer Berlin Heidelberg; 2007. p. 260.

  20. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11(11):CD004014. https://doi.org/10.1002/14651858.CD004014.pub6

  21. Zhang J, Wang JH. Platelet-rich plasma releasate promotes differentiation of tendon stem cells into active tenocytes. Am J Sports Med. 2010;38(12):2477-86. https://doi.org/10.1177/0363546510376750

  22. de Mos M, van der Windt AE, Jahr H, van Schie HT, Weinans H, Verhaar JA, et al. Can platelet-rich plasma enhance tendon repair? A cell culture study. Am J Sports Med. 2008;36(6):1171-8. https://doi.org/10.1177/0363546508314430

  23. Middleton KK, Barro V, Muller B, Terada S, Fu FH. Evaluation of the effects of platelet-rich plasma (PRP) therapy involved in the healing of sports-related soft tissue injuries. Iowa Orthop J. 2012;32:150-63.

  24. Wu YT, Hsu KC, Li TY, Chang CK, Chen LC. Effects of platelet-rich plasma on pain and muscle strength in patients with knee osteoarthritis. Am J Phys Med Rehabil. 2018;97(4):248-54. https://doi.org/10.1097/PHM.0000000000000874

  25. Gupta PK, Acharya A, Khanna V, Roy S, Khillan K, Sambandam SN. PRP versus steroids in a deadlock for efficacy: long-term stability versus short-term intensity-results from a randomised trial. Musculoskelet Surg. 2020;104(3):285-94. https://doi.org/10.1007/s12306-019-00619-w

  26. Alam M, Hughart R, Champlain A, Geisler A, Paghdal K, Whiting D, et al. Effect of platelet-rich plasma injection for rejuvenation of photoaged facial skin: a randomized clinical trial. JAMA Dermatol. 2018;154(12):1447-52. https://doi.org/10.1001/jamadermatol.2018.3977

Published
2022-12-22
How to Cite
1.
Moegni F, Rachman A, Ilyas EI, Harahap A, Irianta T, Hidayat F, Ocviyanti D, Santoso BI. A randomized control trial of platelet-rich plasma in supporting the recovery of postpartum levator ani muscle trauma. Med J Indones [Internet]. 2022Dec.22 [cited 2023Feb.4];31(3):186-92. Available from: https://mji.ui.ac.id/journal/index.php/mji/article/view/6115
Section
Clinical Research