A randomized control trial of platelet-rich plasma in supporting the recovery of postpartum levator ani muscle trauma
DOI:
https://doi.org/10.13181/mji.oa.226115Keywords:
obstetric labor complication, parturition, pelvic floor disorder, platelet-rich plasma, randomized controlled trialAbstract
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.
Downloads
References
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
Davila GW, Ghoniem GM, Wexner SD, editors. Pelvic floor dysfunction: a multidisciplinary approach. London: Springer; 2006. https://doi.org/10.1007/b136174
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
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
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
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
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
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
At?lgan AE, Ayd?n A. Cystocele repair with platelet-rich plasma. Indian J Surg. 2021;83:726-30. https://doi.org/10.1007/s12262-020-02459-6
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
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
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
Dietz HP. Pelvic floor muscle trauma. Expert Rev Obstet Gynecol. 2010;5(4):479-92. https://doi.org/10.1586/eog.10.28
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
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
Schu?ssler 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
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
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
Petros P. The female pelvic floor: unction, dysfunction and management according to the integral theory. 2nd ed. Germany: Springer Berlin Heidelberg; 2007. p. 260.
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
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
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
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.
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
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
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
How to Cite
Issue
Section
License
Authors who publish with Medical Journal of Indonesia agree to the following terms:
- Authors retain copyright and grant Medical Journal of Indonesia right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial License that allows others to remix, adapt, build upon the work non-commercially with an acknowledgment of the work’s authorship and initial publication in Medical Journal of Indonesia.
- Authors are permitted to copy and redistribute the journal's published version of the work non-commercially (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in Medical Journal of Indonesia.