Use of antibiotics in women undergoing correction of an obstetric anal sphincter injury: Results from a national Israeli survey

Abstract Objective Obstetric anal sphincter injures (OASIS) have long‐term implications on women's health. Administration of antibiotic prophylaxis and treatment following OASIS repair is controversial. We conducted a national survey to provide data about practice routines regarding antibiotic prophylaxis and treatment following OASIS repair in Israeli labor and delivery units. Methods A national survey was performed among obstetricians and gynecologists from 24 university‐affiliated delivery centers within the jurisdiction of the Israeli Ministry of Health during 2020. Representatives from each center completed the “Google form” electronic survey. For each questionnaire item, the most common answer was chosen to represent the center's answer. Results The number of physicians who responded per center varied from 1 to 14 (median, 3.5). Preoperative and postoperative antibiotic treatment was given in 75% and 92% of the centers, respectively. While most centers (58.3%) recommend pelvic floor physical therapy on release, recommendations about functional radiologic tests vary. In all centers, there is a designated clinic for postpartum follow‐up of OASIS. Most centers (83%) allow trial of vaginal delivery in the subsequent pregnancy, on an individual basis. Conclusion Heterogeneity exists in managing OASIS in Israel, particularly regarding administration of antibiotics. Further studies are needed to examine the consequences of different management protocols.


| INTRODUC TI ON
Obstetric anal sphincter injuries (OASIS) refer to third and fourthdegree perineal tears during vaginal delivery (VD) that disrupt the anal sphincter and anal mucosa, respectively. 1 OASIS, whether overt or occult, may be the result of an otherwise uneventful VD. 2 Rates of OASIS vary greatly worldwide, between 0.5% and 5% of VD. 3,4 It is believed that the reported rates are an underestimation 1 of the true rates, which are much higher. OASIS may have significant and disabling future consequences on women's physical and mental health, 5 and, as such, early recognition and proper treatment and follow-up are of importance. In practice, guidelines regarding the recommended management during and after the repair, 6 as well as the future follow-up, differ among countries. 7,8 A Cochrane systematic review suggested that prophylactic administration of antibiotics is beneficial in the prevention of perineal wound infection. 9 As a result, the American College of Obstetricians and Gynecologists (ACOG) recommends a single dose of antibiotics at the time of repair. 10 However, an exact regimen has not been established, and there is heterogeneity in the different antibiotic regimens suggested. 11,12 The Israeli Society of Urogynecology and Pelvic Floor Medicine published guidelines on OASIS management in October 2017. 13 These recommendations include performing the surgical repair in the operating room by a gynecologist or a general surgeon, following the administration of prophylactic antibiotics. Stool softeners are recommended in the postpartum period. In addition, the recommended follow-up is daily during hospitalization, and at 4-6 weeks postpartum in a designated clinic. Pelvic floor physical therapy is recommended 6 weeks postpartum. Advanced radiologic tests such as transanal/transperineal ultrasound and manometry are recommended on an individual basis. Future VD may be allowed depending on the patient's preference and current symptoms and following a comprehensive discussion with the treating physician.
Despite the presence of well-defined Israeli guidelines, it appears that not all centers in Israel follow them, and diversity in OASIS management exists. In this current national survey, we aimed to explore the variability in management and adherence with available guidelines.

| MATERIAL S AND ME THODS
A multicenter national survey was performed among physicians from delivery units in 24 university-affiliated medical centers across Israel. The survey was conducted during 2020. In accordance with the local institutional review board, formal ethical approval (Declaration of Helsinki) was waived, since patient information was not revealed. Representatives who treat women with OASIS from the Department of Obstetrics & Gynecology in each medical center filled out the electronic survey using a Google form (Appendix S1). In questionnaire items where an agreement between the representatives was not achieved, the most common answer was chosen to represent that medical center. The questionnaire was constructed and reviewed independently by four of the researchers (MB, RR, AYW, MR) and included items regarding prophylactic and early postpartum antibiotics, primary management and repair of the tear, and management in the early postpartum period and thereafter in subsequent deliveries. All responses were anonymized. Each question had a categorical response as well as a free-text option.
The completed data forms were analyzed using SPSS (version 23, IBM).

| RE SULTS
In Israel there are 28 delivery rooms, of which 24 (86%) are universityaffiliated medical centers; these 24 centers host approximately 90% of all deliveries in the state of Israel. Physicians from all universityaffiliated medical centers with a delivery unit were surveyed and if at least one representative from each medical center responded, that medical center was included in the analysis. Non university-affiliated delivery rooms were not approached. Overall, 200 surveys were sent and 164 were completed, setting the response rate at 82%. The number of respondents per unit varied between 1 and 14, with a median of 3.5. One center reported data for two separate units that are covered by the same physicians using the same protocols.
According to the Israeli society for Maternal-Fetal Medicine, in 2020 the mean annual rate of OASIS tears was approximately 0.5% of vaginal deliveries (grade 3: 1.32%, grade 4: 0.21%). 14 Specifically, the OASIS rate per 100 instrumental and spontaneous vaginal deliveries during that period were 1.9 and 0.5, accordingly. Our study assessed a few fundamental domains in the management and treatment of OASIS. Figure 1 summarizes the questionnaire's results regarding antibiotic administration and primary surgical correction. not given at all. In 16 (75%) of the centers administering antibiotic, a combination of antibiotics is administered. The most prevalent antibiotic is metronidazole, and the most prevalent regimen is intravenous cefuroxime in addition to oral metronidazole.

| Stool softeners
In almost all of the centers (23 [95.8%]), stool softeners are recommended during the postpartum period.

| Physical therapy and anatomic and functional imaging
When discharged from the hospital, 14

| Postpartum visit
In virtually all 24 centers, a designated outpatient clinic follows patients with OASIS during the postpartum period. In 12 (50%) of the centers, the follow-up is conducted by a urogynecologist alone and in three (12.5%) of the centers, the follow-up is conducted by a surgeon alone. In the remaining nine (37.5%) centers, the clinic is multidisciplinary and includes an urogynecologist, a surgeon, and occasionally a gastroenterologist.

| Subsequent deliveries
In four (16.7%) of the centers, a trial of VD is never recommended   The adherence to guidelines and protocols among different fields of medicine has been previously studied and many systems have been created to reinforce medical adherence to the current published literature and to provide patient-centered and consistent care. [18][19][20] The main motivation for standardized care stems from the understanding that different treatment regimens may have different effects on a patient's well-being. In this study, similar to studies in other fields, we have demonstrated that OASIS care in Israel lacks the consistency that is expected when providing medical care in a developed country. We assume that this reflects the situation in additional developed countries. As the Israeli national health plan covers delivery care for all women, adherence to protocols is most probably not biased by financial burdens, which should facilitate standardizing care.

| DISCUSS ION
The implications of differences in management of OASIS have been scarcely studied.
As previously stated, the general use of antibiotics in the management of OASIS is not evidence-based. 21 In a single-center study in Michigan, the implementation of a quality improvement intervention with a single dose of prophylactic antibiotics administration during OASIS repair resulted in a clinically meaningful decrease in wound infections. 22 Of note, this study was underpowered to detect a significant difference in other wound complications. In addition, the exact regimen has not been established. 11,12 In a recently published systematic review, the use of metronidazole during OASIS repair was studied. It was found that despite its wide use during OASIS repair and recovery, this practice is not evidence-based and was not prospectively studied. 21 A systematic review that aimed at evaluating the evidence of routine pelvic floor physical therapy in the management of OASIS concluded that data are scarce and the level of evidence to support this intervention is currently of low quality. 23 With regard to future modes of delivery, a multicenter randomized study from Paris, France, demonstrated that elective cesarean delivery has no advantage in preventing anal incontinence in asymptomatic women. 24 In contrast, a different study found that even among slightly symptomatic women, VD carries a risk of deterioration of anal incontinence symptoms that is higher than in patients undergoing an elective cesarean delivery. 25 Our survey once again highlights the lack of evidence-based medicine in the practical and optimal management of OASIS, one of the most debilitating outcomes of childbirth. Hence, professional organizations, which aim to provide recommendations for optimal health care, need to study the outcomes of different protocols and treatment regimens. An effort should be made to create international evidence-based guidelines on managing OASIS.
Our study has several strengths. First, as far as we know, this was the first survey to investigate this important issue. Second, this was a national study that was sent to all university-affiliated centers in Israel and responses were collected from all of them; the departmental protocols, as well as the obstetrical practice and decision-making processes, were examined throughout a specific study period. In addition, there were several participants from each medical center, which reduces potential recall bias.
Nonetheless, our study was not without limitations. The questionnaire was sent using social media to physicians from all university-affiliated obstetrics and gynecology departments who care for women with OASIS. If at least one physician responded from a medical center, that medical center was included in the analysis.
The study was sent to many physicians who care for women with OASIS and not all of them responded. As a result, the exact number of the physicians who received the questionnaire remains unknown.
Since the study was anonymous, we were not able to characterize those who did not answer, and hence a potential selection bias may exist. However, our aim was to assess the practice routines in Israeli labor and delivery units and not among different physicians.
Moreover, as the response rate was high and answers were diverse, we believe that this would be a nondifferential bias and hence negligible. Additionally, in this study we did not address the actual mode of surgical repair (eg, end-to-end or overlap, sutures type) and hence are not able to provide data on this matter. In addition, in some questions, the answers varied within a single medical center, highlighting not only the inter-unit but even more so the potential intra-unit variation. As stated above, the most prevalent answers were selected; there were no cases of similar rates of two different answers in none of the centers. Lastly, many of the responders in the study were not those who repair the tears; nonetheless, all of the responders were involved in the management of the cases in the delivery rooms, during the early postpartum period, and in the discharge of these women, providing them with specific recommendations; therefore, they could reliably provide answers to the questions asked.
In conclusion, our national survey demonstrated that despite clear national guidelines, the practice in Israel in the management of OASIS is diverse, specifically regarding the administration of preoperative and postoperative antibiotic treatment. This may have implications on women's future health, well-being, and satisfaction.
More studies are needed to compare outcomes resulting from different regimens of antibiotics and to create standardized guidelines accordingly.

AUTH O R CO NTR I B UTI O N S
MB designed, planned, and conducted the study, and wrote the article. RR designed, planned, and conducted the study, and wrote the article. AYB conducted the study. SGG assisted in planning the study. RMC analyzed the data and edited the article. MR designed, planned, and conducted the study.

ACK N OWLED G M ENT
Open access funding enabled and organized by ProjektDEAL.

CO N FLI C T O F I NTE R E S T
None of the authors declare any conflict of interest.

DATA AVA I L A B I L I T Y S TAT E M E N T
Research data are not shared.