Comparison between conservative and surgical management in postpartum pubic symphysis diastasis: a randomized controlled trial

INTRODUCTION

Postpartum pubic symphysis diastasis was earlier assumed to be an uncommon complication with a varying incidence of 1:300 to 1:30,000 due to inconsistent reporting.¹ However, more recent studies suggest that this condition is more common with an incidence between 1:385 and 1:500 births.^2,3 The pubic symphysis is normally 4 to 5 mm in size and undergoes a 2 mm to 3 mm increase during pregnancy.⁴ The etiology of peripartum diastasis of the pubic symphysis without a history of trauma is unknown; but this is associated with underlying connective tissue disorders, cephalopelvic disproportion and macrosomia.⁵ Improper management can lead to significant functional disability and chronic pain.^2,5,6 Clinical diagnosis can be confirmed rapidly by pelvic X-ray and CT scan. Additionally, MRI can exclude soft tissue injury. However, there is no consensus on the optimal therapy. Typically a conservative treatment is performed comprising pelvic binder, analgesia, bed rest in lateral decubitus position and physical therapy.^1,3,5,7-16 In several cases it has been reported that in cases with extreme pubic symphyseal rupture having pelvic instability or persistent pain after conservative therapy, operative treatment is a successful alternative method.^3,17-19 So this study was planned to assess whether surgery (open reduction and internal fixation (ORIF)) provide early pain relief and bring improvement in mobility and quality of life than the usual conservative management does in patients with pubic symphysis diastasis.

The aim of this randomized controlled study is to compare the effectiveness of the surgical management (ORIF) over the standard practice (conservative management) for postpartum pubic diastasis. The pain, ambulation and general health outcome of participants which were measured by EQ-5D score and Pain VAS score during follow up were the main outcomes for this. Our null hypothesis is that there is no difference in the time of pain resolution and the return of pain-free ambulation (no difference in EQ-5D score and pain VAS score) between patients receiving conservative management and surgical management.

METHODS

Study design and participants

The present study is a randomized controlled trial (parallel trial) conducted at MKCG Medical College, Berhampur from December 2014 to April 2017. Prior to the study ethical approval has been obtained from the ethical committee of MKCG Medical College. Patients with postpartum pubic diastasis coming to MKCG hospital within the study period were enrolled for the study.

Patients in the age group of 20 to 40 years and with postpartum pubic diastasis of more than 5 cms gap were included and patients with a history of pelvic trauma, connective tissue disorder, Cushing disease and hypoparathyroidism, an extreme symphyseal rupture with pelvic instability and cases more than 2 weeks old were excluded. Assuming a minimal 2 score improvement in the EQ-5D descriptive index, standard deviation as 3 and mean index in the treatment group as 8 and in control group as 10, the sample size was calculated to be 20 to achieve 90% power at 5% level of significance. In our study total 16 eligible patients were enrolled during the study period.

Methodology

The patients were randomly assigned to two groups in 1:1 ratio. Group A (intervention group) consists of 8 patients who received surgical management and group B (control group) of 8 patients who received a standard procedure that is conservative management. Due to the nature of intervention masking of patients was not possible. Informed consent was obtained from patients prior to the study. All participants were provided with a patient information sheet and had an opportunity for discussion with a principal investigator at their first orthopaedic attendance.

Intervention

In the study, the intervention was surgical management (ORIF). For the procedure, Pfannenstiel approach was done under spinal anaesthesia in the supine position, reduction of symphysis pubis was done and fixed with 3.5 reconstruction plate and 3.5 cortical screws. A suction drain was given and the wound was closed in layers. Standard postoperative rehabilitation protocol maintained. Stitches were removed on the 12th day. Pelvic exercises were started from 2^nd postoperative day. Partial weight bearing given on 3^rd postoperative day with help of walker. Serial radiographs were obtained immediately after the operation, at 3 weeks, at 6 weeks and at 3 months of follow up. Conservative management was done in form of analgesics (NSAIDS and Opioids), bed rest, pelvic binder and physical therapy. Patients were given pelvic binder and analgesics as per requirement. Physical therapy was implemented to all patients. All the patients were gradually mobilized according to their pain tolerance with the help of a walker and subsequently to walking stick after 3weeks or even more in some cases. All patients in both groups were followed up at 3 weeks, 6 weeks, 3 months and 6 months of their management. At the time of admission to the hospital all patients were assessed in form of routine blood investigation, X-ray of the pelvis with both hip- AP inlet and outlet views and CT SCAN of the pelvis. A thorough clinical examination was done.

Outcome measurement

The general health outcome, pain and ambulation in patients were the primary outcomes in the study. The variables were measured with help of EuroQol Group 5-Dimension self-report questionnaire 3 level version (EQ-5D-3L) at each follow-up visit. This tool is used worldwide. It includes an EQ-5D descriptive index and EQ visual analogue scale (EQ VAS). EQ descriptive index consists of 5 dimensions like mobility, self-care, usual activities, pain/discomfort, anxiety/depression. It ranges from 5 to 15 and a lower score indicates better general health outcome and pain relief. EQ VAS score records self-rated health state in people. Its score ranges from 0 to 100 where 0 is worst imaginable health state and 100 is best imaginable health state.²⁰. For recording pain in patients, Visual analogue scale (VAS) was used which ranges from 0 to 100. Pain VAS score 0-4 means no pain, 5-44 means mild, 45-74 is moderate and 75-100 indicates severe pain. Reliability of this tool is good and validity is high (correlation ranges from 0.62-0.91 for numeric rating scale).²¹ In the study, this score was obtained with face to face interview by an investigator who was blinded to reduce bias.

Statistical analysis

All data were analyzed with SPSS (version 16). To reduce bias during interpretation randomization code was broken before analysis. To assess the superiority, mean of scores between two groups analyzed. As variables were continuous data and not normally distributed across participants, nonparametric test (Mann-Whitney test) was applied to compare the means of outcomes in the two groups. In the study P value less than 0.05 was taken as statistical significant.

RESULTS

A total 16 patients underwent randomization (Figure 1), 50% assigned to surgical treatment group (A) and 50% to the conservative treatment group (B). All participants were followed up to the end of follow up period and loss of follow up was nil. None of the patients of group A had implant failure. Perioperative and postoperative were uneventful. Baseline characteristics of all participants were depicted in Table 1.

EQ-5D score and pain VAS score of each study participants at the time of admission, 3 weeks, 6 weeks, 3 months, 6 months were described in Table 2 and 3.

6 out of 8 patients in group A had EQ-5D score 5 at 6 months of follow up but no one in group B attained EQ-5D score 5 at the same time. The suprapubic pain was present in all patients of group B and 1 patient of group A at end of follow up. The comparative analysis of EQ-5D score and Pain VAS score between patients with conservative management and with surgical management were elucidated in Table 4.

*statistical significant as P value less than 0.05.

Radiographical image of patients at preoperative and 6 weeks postoperative period is shown in Figure 2 and 3.

DISCUSSION

The present study examined the effectiveness of surgical management over conservative management in patients with pubic symphysis diastasis. Our analysis showed that at the time of admission the mean EQ-5d descriptive index was almost similar in both group, but it declined more rapidly during follow up period in group A patients where ORIF was done as compared to that in group B patients where conservative management was employed. 75% of participants of group A has EQ-5D descriptive index 5 (which is the lowest score) at 6 months of follow up. But none of the patients in group B patients attained it at the same follow-up period. A lower EQ-5D descriptive index in group A patients indicates patients had good mobility and early ambulation, less discomfort, less pain, were able to do self-care and daily activity. But group B participants had persistent pain, low mobility and face difficulty in doing usual activities at 6 months of follow up. Similarly, mean EQ VAS score was higher in group A than that in group B which indicates patients receiving ORIF had better health state than patients with conservative management. Mean EQ-5D index in group B remained higher than that in group A throughout the follow-up period and this difference was significant in each follow-up visit.

Similarly, pain VAS score was same in both the groups at the time of admission. But with the follow-up time mean pain VAS score declined drastically in group A where as in group B it was slower. At the end of follow-up period mean VAS score in group A was below 4 (means no pain) where as in group B it was 26±2.5 (score between 5-44 means mild pain). 1 patient in group A and all patients in group B had persistent suprapubic pain at the end of the follow-up period. The difference in the mean VAS score between two groups’ patients was statistically significant at each follow-up time. So at the end this study illustrated that early surgical consideration and intervention for postpartum diastasis of the pubic symphysis can result in improved outcome including improved pain management and return to ambulation. When surgical management is implemented, it likely to decreases the recovery time and improve overall functional outcome.

Kharrazi et al has reported patients with conservative management had persistent posterior pelvic pain after 2 years and suggested consideration of operative approach for these cases.²² Incomplete recovery from pain in case of conservative management was also found by Rommens et al in their case reort.⁶ Dunivan et al stated that aggressive treatment of severe pubis symphysis separation with external fixation results in early ability to ambulate and care for self.²³ Graf et al in the case report illustrated that patient was able to ambulate without complaints after 2 weeks of ORIF of pubic symphysis separation of 60 mm.²⁴ Snow et al, Rommens et al, Dunivan et al opined that pubic symphysis gap more than 4 cm is an indication for operative plate fixation.^1,6,23

In contrast, many articles have shown that conservative therapy is a reasonable approach.^1,7,15,25,26 Joosoph et al observed that a patient with 45 mm pubic symphysis gap was able to walk independently with a walking stick and no longer felt pain after 1 month of conservative management. However, 20 mm separation was still there. At 7 months and 3 years after her delivery, her X ray showed that 20 mm gap persisted, however she remained well.⁷ The effectiveness of conservative management approach was also found by Senechal et al and Dunbar et al in their studies.^25,26 Good results reported even with diastasis measuring 9 cm associated with sacroiliac joint by Idrees et al and 5 cm gap by Culligan et al.^8,27 Cowling et al found successful outcome by conservative management in a case of 9.5 cm diastasis.²⁸

Limitations of the study

Possible bias due to self-reported score value may be a possible bias, although we recorded no evidence for bias caused by this. If participants could be followed up for more periods, a better result could be obtained. However, the desired effect of the intervention was almost achieved in the intervention group within the follow-up period.

CONCLUSION

This study showed that surgical management is more effective than conservative management in postpartum pubic symphysis patients by rapidly improving general health, ameliorating pain and bringing ambulation. This study shows that early orthopaedic consultation and surgical consideration can improve outcomes when symphyseal separations are greater than 5 cm where conservative management has been frequently employed. Delay in surgical intervention has short and long-term risks which may be compounded by partial healing and increased surgical complexity. When surgical management is implemented, it is likely to decrease recovery time and improve overall functional outcome. Post-Partum Pubic diastasis, which is many times overlooked by the obstetricians and orthopaedic surgeons, is a disabling condition requires prompt and rightful intervention.

ACKNOWLEDGEMENTS

The authors express their gratitude towards all study participants for their valuable time. Authors would like to extend their gratitude to the staffs of the department of Orthopaedics, MKCG Medical College, Berhampur for their contributions and technical supports.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the institutional ethics committee

REFERENCES

1. 1. Snow RE, Neubert AG. Peripartum pubic symphysis separation: a case series and review of the literature. Obstetrical Gynecol Survey. 1997;52(7):438–43.
2. 2. Nitsche J, Howell T. Peripartum pubic symphysis separation: a case report and review of the literature. Obstetrical Gynecol Survey. 2011;66(3):153–58.
3. 3. Yoo JJ, Ha YC, Lee YK, Hong JS, Kang BJ, Koo KH. Incidents and risk factors of symptomatic peripartum diastasis of pubic symphysis. J Korean Med Sci. 2014;29(2):281-6.
4. 4. Jain S, Eedarapalli P, Jamjute P, Sawdy R. Symphysis pubis dysfunction: a practical approach to management. Obstet Gynaecol. 2006;8(3):153–8.
5. 5. Jain N, Sterberg LB. Symphyseal separation. Obstet Gynecol. 2005;105(5):1229-32.
6. 6. Rommens PM. Internal fixation in postpartum symphysis pubis rupture: report of three cases. J Orthopaedic Trauma. 1997:11(4):273–6.
7. 7. Joosoph J, Kwek K. Symphysis pubis diastasis after normal vaginal birth: a case report. Annals Acad Med Singapore. 2007;36(1):83–185.
8. 8. Idrees A. Management of chronic symphysis pubis pain following child birth with spinal cord stimulator. J Pak Med Assoc. 2012;62:71–3.
9. 9. Pedrazzini A, Bisaschi R, Borzoni R, Simonini D,Guardoli A. Postpartum diastasis of the pubic symphysis: a case report. Acta Biomedica de l'Ateneo Parmense. 2005;76(1):49–65.
10. 10. Lindsey RW, Leggon RE, Wright DG, Nolasco DR. Separation of the symphysis pubis in association with childbearing: A case report. J Bone Joint Surg Am 1988;70:289-92.
11. 11. Topuz S, Citil I, Iyibozkurt AC, Dursun M, Akhan SE, Has R, et al. Pubic symphysis diastasis: imaging and clinical features. European J Radiol. 2006;59:127–9.
12. 12. Scriven MW, Jones DA, McKnight L. The importance of pubic pain following childbirth: a clinical and ultrasonographic study of diastasis of the pubic symphysis. J R Soc Med. 1995;88:28–30.
13. 13. Fuller JG, Janzen J, Gambling DR. Epidural analgesia in the management of symptomatic symphysis pubis diastasis. Obstet Gynecol. 1989;73:855-7.
14. 14. Kowalk DL, Perdue PS, Bourgeois FJ, Whitehill R. Disruption of the symphysis pubis during vaginal delivery. A case report. J Bone Joint Surg Am. 1996;78:1746-8.
15. 15. Penning D, Gladbach B, Majchrowski W. Disruption of the pelvic ring during spontaneous childbirth. J Bone Joint Surg Br. 1997;79:438-40.
16. 16. Dhar S, Anderton JM. Rupture of the symphysis pubis during labor. Clin Orthop Relat Res. 1992;283:252-7.
17. 17. Zhiyong H, John TR, Wade RS, Kent AS, Patrick JM. Severe postpartum disruption of the pelvic ring: report of two cases and review of the literature. Patient Safety Surg. 2011;5:2-6.
18. 18. Callahan JT. Separation of the symphysis pubis. Am J Obstet Gynecol. 1953;66:281-93.
19. 19. Seth S, Das B, Salhan S. A severe case of pubic symphysis diastasis in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2003;106:230-2.
20. 20. Van R M, Oppe M. EQ-5D-3L User Guide Basic information on how to use the EQ-5D-3L instrument. 2015 Available from: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf.
21. 21. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF. Arthritis Care Res (Hoboken) [Internet]. 2011;63(11):240–52.
22. 22. Kharrazi FD, Rodgers WB, Kennedy JG, Lhowe DW. Parturition-induced pelvic dislocation: a report of four cases. J Orthop Trauma. 1997;11(4):277-81.
23. 23. Dunivan GC, Hickman AM, Connolly A. Severe separation of the pubic symphysis and prompt orthopedic surgical intervention. Obstetrics Gynecol. 2009;114(2):473–5.
24. 24. Gräf C, Sellei RM, Schrading S, Bauerschlag DO, Bauerschlag DO. Treatment of parturition-induced rupture of pubic symphysis after spontaneous vaginal delivery. Case Rep Obstet Gynecol. 2014;2014:485916.
25. 25. Senechal PK. Symphysis pubis separation during childbirth. J American Board Family Pract. 1994;7(2):141–4.
26. 26. Dunbar RP, Ries AM. Puerperal diastasis of the pubic symphysis: a case report. J Reproductive Med Obstetrician Gynecologist. 2002;47(7):581–3.
27. 27. Culligan P, Hill S, Heit M. Rupture of the symphysis pubis during vaginal delivery followed by two subsequent uneventful pregnancies. Obstetrics Gynecol. 2002;10(5):1114–7.
28. 28. Cowling PD, Rangan A. A case of postpartum pubic symphysis diastasis. Injury. 2010;41:657.