Vaginal delivery in SARS-CoV-2-infected pregnant women in Israel: a multicenter prospective analysis.

KEY MESSAGE: Among SARS-CoV-2-infected mothers, vaginal delivery rates were high and associated with favorable outcomes with no cases of neonatal COVID-19. PURPOSE: To investigate the mode of delivery and its impact on immediate neonatal outcome in SARS-CoV-2-infected women. METHODS: A prospective study following pregnant women diagnosed with COVID-19 who delivered between March 15th and July 4th in seven university affiliated hospitals in Israel. RESULTS: A total of 52 women with a confirmed diagnosis of COVID-19 delivered in the participating centers during the study period. The median gestational age at the time of delivery was 38 weeks, with 16 (30.8%) cases complicated by spontaneous preterm birth. Forty-three women (82.7%) underwent a trial of labor. The remaining 9 women underwent pre-labor cesarean delivery mostly due to obstetric indications, whereas one woman with a critical COVID-19 course underwent urgent cesarean delivery due to maternal deterioration. Among those who underwent a trial of labor (n = 43), 39 (90.7%) delivered vaginally, whereas 4 (9.3%) cases resulted in cesarean delivery. Neonatal RT-PCR nasopharyngeal swabs tested negative in all cases, and none of the infants developed pneumonia. No maternal and neonatal deaths were encountered. CONCLUSIONS: In this prospective study among SARS-CoV-2-infected mothers, vaginal delivery rates were high and associated with favorable outcomes with no cases of neonatal COVID-19. Our findings underscore that delivery management among SARS-CoV-2-infected mothers should be based on obstetric indications and may potentially reduce the high rates of cesarean delivery previously reported in this setting.

Postoperative radiation rates in stage IIA1 cervical cancer: Is surgical treatment justified? An Israeli Gynecologic Oncology Group Study.

OBJECTIVES: Data on the outcome of stage IIA1 cervical cancer is limited, as these tumors comprise a small percentage of early tumors. NCCN guidelines suggest consideration of surgical management for small tumors with vaginal involvement. Our objective was to evaluate the risk of adjuvant radiotherapy in stage IIA1 cervical cancer and its associated features, in order to improve selection of patients for surgical management. METHODS: A retrospective cohort study comparing surgically treated cervical cancer patients with stage IB1 and stage IIA1 disease. Women treated between 2000 and 2015 in ten Israeli medical centers were included. Patient and disease features were compared between stages. The relative risk (Fisher's exact test) of receiving post-operative radiation was calculated and compared for each risk factor. A general linear model (GLM) was used for multivariable analysis. RESULTS: 199 patients were included, of whom 21 had stage IIA1 disease. Most features were comparable for stage IB1 and stage IIA1 disease, although patients with vaginal involvement were more likely to have close surgical margins (23.8% vs 8.5%, p = 0.03). Patients with stage IIA1 disease were more likely to receive radiation after surgery (76% vs. 46%, RR = 1.65 (1.24-2.2), p = 0.011). Vaginal involvement as well as depth of stromal invasion, LVSI and lymph node metastases were independent predictors of radiation on multivariable general linear modeling. CONCLUSIONS: Cervical cancer patients with vaginal involvement are highly more likely to require postoperative radiation. We recommend careful evaluation of these patients before surgical management is offered.

Medium-term results of Mini-arc for urinary stress incontinence in ambulatory patients under local anesthesia.

OBJECTIVE: To evaluate the medium-term outcome and patient's satisfaction after Single-incision mini-sling (SIMS) procedure done under local anesthesia in ambulatory set up for patients with stress urinary incontinence (SUI). MATERIALS AND METHODS: This is a retrospective cohort study, including all patients submitted to SIMS procedure for SUI with MiniArc (AMS, U.S.A) without concomitant surgery between January 2011 and March 2013. Patients were followed up during 12 months after surgery and once a year subsequently. Telephone interviews were conducted to evaluate patient satisfaction. Outcome masseurs included: SUI cure rate, urinary urge incontinence (UUI) cure rate in patients with mixed urinary incontinence (MUI), intra and post-operative complications and patient satisfaction. RESULTS: Ninety-three patients were included with mean follow-up of 23 months. Fifty percent had MUI with predominant SUI. The cure rates of SUI (objective and subjective) were 89%. UUI was cured in 40% of patients. No major complications occur, neither voiding obstruction or groin pain. Telephone interviews conducted after 26 months on average revealed high satisfaction rate from the procedure (8.8 out of 10) and from the local anesthesia. Visual analog scale (VAS) rating was low during and after the procedure (2.38 and 2.69 respectively). CONCLUSIONS: The SIMS procedure is safe and highly effective for SUI and it can be performed successfully under local anesthesia in an ambulatory setup.

Uterine preservation for advanced pelvic organ prolapse repair: Anatomical results and patient satisfaction.

OBJECTIVE: The aims of the current study were to evaluate outcomes and patient satisfaction in cases of uterine prolapse treated with vaginal mesh, while preserving the uterus. MATERIALS AND METHODS: This is a retrospective cohort study that included all patients operated for prolapse repair with trocar-less vaginal mesh while preserving the uterus between October 2010 and March 2013. Data included: patients pre-and post-operative symptoms, POP-Q and operative complications. Success was defined as prolapse < than stage 2. A telephone survey questionnaire was used to evaluate patient's satisfaction. RESULTS: Sixty-six patients with pelvic organ prolapse stage 3, including uterine prolapse of at least stage 2 (mean point C at+1.4 (range+8-(-1)) were included. Mean follow-up was 22 months. Success rate of the vaginal mesh procedure aimed to repair uterine prolapse was 92% (61/66), with mean point C at -6.7 (range (-1) - (-9)). No major intra-or post-operative complication occurred. A telephone survey questionnaire was conducted post-operatively 28 months on average. Ninety-eight percent of women were satisfied with the decision to preserve their uterus. Eighteen patients (34%) received prior consultation elsewhere for hysterectomy due to their prolapse, and decided to have the operation at our center in order to preserve the uterus. CONCLUSIONS: Uterine preservation with vaginal mesh was found to be a safe and effective treatment, even in cases with advanced uterine prolapse. Most patients prefer to keep their uterus. Uterus preservation options should be discussed with every patient before surgery for pelvic organ prolapse.

Counseling for fetal macrosomia: an estimated fetal weight of 4,000 g is excessively low.

OBJECTIVE: Because of the known complications of fetal macrosomia, our hospital's policy has been to discuss the risks of shoulder dystocia and cesarean section (CS) in mothers with a sonographic estimated fetal weight (SEFW) ≥ 4,000 g at term. The present study was performed to determine the effect of this policy on CS rates and pregnancy outcome. STUDY DESIGN: We examined the pregnancy outcomes of the macrosomic (≥ 4,000 g) neonates in two cohorts of nondiabetic low risk women at term without preexisting indications for cesarean: (1) SEFW ≥ 4,000 g (correctly suspected macrosomia) and (2) SEFW < 4,000 g (unsuspected macrosomia). RESULTS: There were 238 neonates in the correctly suspected group and 205 neonates in the unsuspected macrosomia group, respectively. Vaginal delivery was accomplished in 52.1% of the suspected group and 90.7% of the unsuspected group, respectively, p < 0.001. There was no difference in the rates of shoulder dystocia. The odds ratio for CS was 9.0 (95% confidence interval, 5.3-15.4) when macrosomia was correctly suspected. CONCLUSION: The policy of discussing the risk of macrosomia with SEFW ≥ 4,000 g to women is not justified. A higher SEFW to trigger counseling for shoulder dystocia and CS, more consistent with American College of Obstetrics and Gynecology (ACOG) guidelines, should be considered.

Reconsidering the Current Preterm Premature Rupture of Membranes Antibiotic Prophylactic Protocol.

OBJECTIVE: The purpose of our study was to determine whether the current antibiotic regimen for preterm premature rupture of membranes (PPROM) is adequate for covering the current causative agents and sensitivities of chorioamnionitis and early-onset neonatal sepsis. STUDY DESIGN: During a 3-year period, we retrieved the results from placental and amniotic membrane cultures obtained at delivery in cases of maternal fever, chorioamnionitis, and PPROM, and from blood cultures obtained from neonates with early-onset sepsis (EOS) in three participating hospitals. Sensitivity of pathogens to antimicrobial agents was performed using routine microbiologic techniques. RESULTS: There were 1,133 positive placental or amniotic cultures, 740 (65.3%) were from gram-negative Enterobacteriaceae. There were 27 neonates diagnosed with EOS with positive blood cultures. Aerobic Enterobacteriaceae accounted for 14 cases (52%) and group B streptococcus for 7 cases (26%). Of the Escherichia coli and Klebsiella sp., only 38% were sensitive to ampicillin. CONCLUSION: Local pathogens and their antibiotic sensitivity profiles should be explored every few years and an effective antibiotic protocol chosen to cover the main pathogens causing chorioamnionitis and EOS. Consideration should be made for changing ampicillin in women with PPROM to a regimen with better coverage of gram-negative Enterobacteriaceae.

Assessment of oncological safety and utility of hysteroscopy in high grade endometrial cancers: Results from an Israel gynecologic oncology group study.

OBJECTIVE: To compare survival measures of women with Stage I high-grade endometrial cancer who underwent either hysteroscopy or a non-hysteroscopic procedure as a diagnostic procedure. STUDY DESIGN: 298 patients with stage I high grade endometrial cancer who underwent surgery between 2002 and 2014. Patients were divided into two groups: hysteroscopy and non-hysteroscopy (curettage or office endometrial biopsy). Clinical, pathological, and survival measures were compared between the groups. High grade histology included endometroid grade -3, uterine serous papillary carcinoma, clear cell carcinoma, and carcinosarcoma. RESULTS: There were 71 patients in the hysteroscopy group and 227 patients in the non-hysteroscopy group. The median follow-up was 52 months (range 12-120 months). There were no differences between the groups in the 5-year recurrence-free survival (73.9 % vs. 79.7 %; p = 0.65), disease-specific survival (79.3 % vs. 83.6 %; p = 0.87), and overall survival (65.7 % vs. 80.3 %; p = 0.35). CONCLUSION: Hysteroscopic diagnosis in women with early-stage and high-grade endometrial cancer does not adversely affect the survival outcomes.

Does sentinel lymph node biopsy in endometrial cancer surgery have an impact on the rate of adjuvant post operative pelvic radiation? An Israeli Gynecologic Oncology Group Study.

Objective: To compare the rates of post-operative radiotherapy between two methods of lymph nodes assessment during surgical staging for endometrial cancer (EC). Methods: We conducted a comparative study of all consecutive women with endometrial cancer who underwent sentinel lymph node detection and biopsy using blue dye and isotope scan (SLNB) at Kaplan Medical Center and patients from the IGOG database, who underwent staging lymphadenectomy (PLND). The primary outcome was the rate of adjuvant and therapeutic radiation. The secondary outcome was a comparison of disease-free survival (DFS) and overall survival (OS). Results: There were 138 patients in the SLNB group and 1022 women in the PLND group. The detection rate of SLN was 74% for unilateral detection and 54% for bilateral detection. In the PLND group 57% were high risk patients vs. 47% in SLNB group (p = 0.03). 43% of high-risk patients in the PLND group received adjuvant or therapeutic pelvic radiation vs. 28% of high-risk women in the SLNB arm (p = 0.017). No statistically significant difference in recurrence rates nor in death rates had been observed in the high-risk group patients. The 5-years survival in the high-risk PLND group was 80% and the recurrence rate was 19% vs. 75% 5-year survival and 14% recurrence in high-risk SLNB cohort, log-rank p = 0.82 for survival and long-rank p = 0.25 for recurrence. Conclusion: Endometrial cancer patients undergoing lymph node assessment by sentinel lymph node biopsy, receive less pelvic radiotherapy.

Prediction of endometrial cancer recurrence by using a novel machine learning algorithm: An Israeli gynecologic oncology group study.

OBJECTIVES: Endometrial cancer is the most common gynecologic malignancy in developed countries. The overall risk of recurrence is associated with traditional risk factors. METHODS: Machine learning was used to predict recurrence among women who were diagnosed and treated for endometrial cancer between 2002 and 2012 at elven university-affiliated centers. The median follow-up time was 5 years. The following data were retrieved from the medical records and fed into the algorithm: age, chronic metabolic diseases, family and personal cancer history, hormone replacement therapy use, endometrial thickness, uterine polyp presence, complete blood count results, albumin, Ca-125 level, surgical staging, histology, depth of myometrial invasion, LVSI, grade, pelvic washing cytology, and adjuvant treatment. We used XGBoost algorithm, which fits the training data using decision trees, and can also rate the factors according to their influence on the prediction. RESULTS: 1935 women were identified of whom 325 had recurrent disease. On the randomly picked samples, the specificity was 55% and the sensitivity was 98%. Our model showed an operating characteristic curve with AUC of 0.84. CONCLUSIONS: A machine learning algorithm presented promising ability to predict recurrence of endometrial cancer. The algorithm provides an opportunity to identify at-risk patients who may benefit from adjuvant therapy, tighter surveillance, and early intervention.

A novel extended prophylactic antibiotic regimen in preterm pre-labor rupture of membranes: A randomized trial.

OBJECTIVES: Prophylactic antibiotic use in preterm pre-labor rupture of membranes (PPROM) is associated with a significant reduction in intra-amniotic infection and improved neonatal outcome. However, data is insufficient to determine the optimal antibiotic regimen. Considering the rise in Escherichia coli and Klebsiella pneumonia early-onset sepsis rate and the emergence of ampicillin resistance, our aim is to compare the efficiency of two antibiotic regimens in prolonging pregnancy and reducing infectious morbidity. DESIGN: This multicenter randomized unblinded controlled prospective trial compared two antibiotic prophylactic protocols in PPROM: ampicillin + roxithromycin vs. cefuroxime + roxithromycin in 84 women with PPROM, from 12/2015-12/2019. RESULTS: The median latency period was significantly longer (p = 0.039) in the cefuroxime + roxithromycin group (4.63 [0.59-50.18] days) than in the ampicillin + roxithromycin group (2.3 [0.15-58.3] days). Neonatal admission to neonatal intensive care unit rate, hospitalization length, neonatal respiratory distress syndrome, neonatal fever, and need for respiratory support or mechanical ventilation, were similar between the groups. K. pneumonia cultures were significantly more frequent in the ampicillin + roxithromycin group. None of the cultures were group B Streptococcus positive. CONCLUSIONS: To prolong latency period and reduce gram-negative early-onset sepsis, cefuroxime + roxithromycin is recommended as the first-line protocol in PPROM. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02819570.

An Israeli Gynecologic Oncology Group study of statin use and endometrial cancer prognosis.

OBJECTIVE: To assess whether statin use by endometrial cancer patients was associated with a survival advantage. METHODS: A retrospective chart review study, by the Israeli Gynecologic Oncology Group, of consecutive endometrial cancer patients who underwent surgery in one of 11 medical centers between 2002 and 2014. Clinical and pathological reports, and measures of survival were compared between statin users and nonusers. Kaplan-Meier and Cox proportional hazard models were used to assess the effect of using statins on survival measures. RESULTS: Over a mean follow-up period of 6.2 years (range, 1-12 years) for 2017 endometrial cancer patients with complete data, 663 (32.8%) used statins prior to diagnosis and 1354 (67.1%) did not. No statistically significant differences between the groups were observed for most demographic and clinical characteristics. There was no difference between statin users and nonusers in 5-year recurrence-free survival (82% vs 83%; P=0.508), disease-specific survival (86% vs 84%; P=0.549), or overall survival (77% vs 75%; P=0.901). CONCLUSIONS: In this large cohort of patients with endometrial cancer, no significant associations were found between use of statins and endometrial cancer survival.

Evaluation of Clinical and Pathologic Risk Factors May Reduce the Rate of Multimodality Treatment of Early Cervical Cancer.

OBJECTIVE: To assess the rate of postoperative adjuvant treatment in patients who underwent radical hysterectomy for early cervical cancer and to suggest criteria for the triage of patients who have a high probability of multimodality treatment. METHODS: This was a multicenter retrospective study of 514 patients with FIGO stages IA2-IIA cervical cancer who underwent radical hysterectomy between 1999 and 2010. The patients were divided into 2 groups according to whether or not postoperative radiation was administered. The 2 groups were compared with regard to clinical and histopathologic variables divided into major and minor criteria (intermediate risk factors) based on lymph nodes status, parametrial involvement, tumor size, deep stromal invasion, and lymph-vascular space invasion. RESULTS: We identified 294 (57.2%) patients who received adjuvant postoperative radiotherapy (RT) or chemoradiation. Fifty-three percent of these patients who were treated by adjuvant radiation had only intermediate risk factors. Combining the various combinations of 2 out of 3 of the following criteria, we found that 89% of patients with tumors ≥2 cm and lymph-vascular space invasion received RT, 76% of patients with tumors ≥2 cm and depth of invasion >10 mm received RT, and 87% of patients with tumors depth of invasion >10 mm and lymph-vascular space invasion received RT. CONCLUSIONS: This study suggests that in patients with early cervical cancer, clinicopathologic evaluation of tumor size and lymph-vascular space invasion should be undertaken before performing radical hysterectomy. This approach can serve to tailor treatment, reducing the rate of employing both radical hysterectomy and chemoradiation.

Uterine preservation for advanced pelvic organ prolapse repair: Anatomical results and patient satisfaction

ABSTRACT Objective: The aims of the current study were to evaluate outcomes and patient satisfaction in cases of uterine prolapse treated with vaginal mesh, while preserving the uterus. Materials and Methods: This is a retrospective cohort study that included all patients operated for prolapse repair with trocar-less vaginal mesh while preserving the uterus between October 2010 and March 2013. Data included: patients pre-and post-operative symptoms, POP-Q and operative complications. Success was defined as prolapse < than stage 2. A telephone survey questionnaire was used to evaluate patient's satisfaction. Results: Sixty-six patients with pelvic organ prolapse stage 3, including uterine pro-lapse of at least stage 2 (mean point C at+1.4 (range+8-(-1)) were included. Mean follow-up was 22 months. Success rate of the vaginal mesh procedure aimed to repair uterine prolapse was 92% (61/66), with mean point C at −6.7 (range (-1) - (-9)). No major intra-or post-operative complication occurred. A telephone survey questionnaire was conducted post-operatively 28 months on average. Ninety-eight percent of women were satisfied with the decision to preserve their uterus. Eighteen patients (34%) received prior consultation elsewhere for hysterectomy due to their prolapse, and decided to have the operation at our center in order to preserve the uterus. Conclusions: Uterine preservation with vaginal mesh was found to be a safe and effective treatment, even in cases with advanced uterine prolapse. Most patients prefer to keep their uterus. Uterus preservation options should be discussed with every patient before surgery for pelvic organ prolapse.

Medium-term results of mini-arc for urinary stress incontinence in ambulatory patients under local anesthesia

Abstract Objective To evaluate the medium-term outcome and patient's satisfaction after Single-incision mini-sling (SIMS) procedure done under local anesthesia in ambulatory set up for patients with stress urinary incontinence (SUI). Materials and Methods This is a retrospective cohort study, including all patients submitted to SIMS procedure for SUI with MiniArc (AMS, U.S.A) without concomitant surgery between January 2011 and March 2013. Patients were followed up during 12 months after surgery and once a year subsequently. Telephone interviews were conducted to evaluate patient satisfaction. Outcome masseurs included: SUI cure rate, urinary urge incontinence (UUI) cure rate in patients with mixed urinary incontinence (MUI), intra and post-operative complications and patient satisfaction. Results Ninety-three patients were included with mean follow-up of 23 months. Fifty percent had MUI with predominant SUI. The cure rates of SUI (objective and subjective) were 89%. UUI was cured in 40% of patients. No major complications occur, neither voiding obstruction or groin pain. Telephone interviews conducted after 26 months on average revealed high satisfaction rate from the procedure (8.8 out of 10) and from the local anesthesia. Visual analog scale (VAS) rating was low during and after the procedure (2.38 and 2.69 respectively). Conclusions The SIMS procedure is safe and highly effective for SUI and it can be performed successfully under local anesthesia in an ambulatory setup.

Maternal mortality following diagnostic 2nd-trimester amniocentesis.

We present 2 cases of maternal mortality after transabdominal amniocentesis performed during the 2nd trimester of pregnancy. In both these cases, blood cultures revealed Escherichia coli. Broad-spectrum intravenous antibiotic treatment started immediately after admission to the hospital did not change the rapid progression of the disease. Despite evacuation of the uterus within <10 h from the diagnosis of septic abortion and transfer to the intensive care units to treat multiorgan failure, these patients died. Septic abortion and septic shock following transabdominal amniocentesis are very rare; however, they carry a serious risk to the patients' life. The combination of fever and leukopenia several days after amniocentesis should alert the physician to the evolution of sepsis. Because of the risk involved, information given to the patient prior to amniocentesis should refer to possible fetal complications and to the remote possibility of maternal risks as well.