Clinical evaluation of peripartum outcomes of mediolateral versus lateral episiotomy.

OBJECTIVE: To evaluate the incidence and extent of vaginal and perineal trauma among primiparous women after mediolateral and lateral episiotomy. METHODS: In a prospective randomized study at University Hospital Pilsen, Czech Republic, 790 consecutive primiparous women were enrolled between April 2010 and April 2012. Mediolateral episiotomy (MLE) followed an angle of at least 60° from the midline. Lateral episiotomy (LE) started 1-2 cm laterally from the midline and was directed toward the ischial tuberosity. A rectal examination was performed before episiotomy repair. RESULTS: MLE was performed for 390 women, and LE for 400. The groups did not differ in maternal or neonatal characteristics. No difference was found in incidence or extent of vaginal and perineal trauma; or in additional perineal (1.8% vs 1.5%, P=0.6) or vaginal (8.5% vs 10.6%, P=0.2) trauma continuing along the episiotomy incision. The incidence of anal sphincter injury did not differ between MLE and LE (1.5% vs 1.3%, P=0.7). MLE was associated with shorter repair times (P<0.05), less suturing material (P<0.05), and shorter distances from the anus (P<0.001). CONCLUSION: Risk of additional vaginal and perineal trauma, and anal sphincter injury after adequately performed mediolateral episiotomy is relatively low and corresponds to that of lateral episiotomy.

Clinical evaluation of early postpartum pain and healing outcomes after mediolateral versus lateral episiotomy.

OBJECTIVE: To evaluate short-term perineal pain among primiparous women after mediolateral episiotomy (MLE) and lateral episiotomy (LE). METHODS: The prospective randomized study was conducted in the Czech Republic during 2010-2012. Consecutive primiparous women who gave birth at or after 37 weeks of pregnancy and had indications for an episiotomy were enrolled and randomly assigned to undergo MLE or LE. Patients were unaware of the episiotomy type performed. The primary outcomes were pain at 24 hours, 72 hours, and 10 days post partum, measured by a visual analog scale, verbal rating scale, interference with activities of daily living, and amount of analgesic use. RESULTS: The analysis included 266 women who underwent MLE and 297 women who underwent LE. Complete relief of pain was observed in 6 (2.3%) of 266 women after 24 hours, 21 (8.0%) of 264 after 72 hours, and 77 (29.1%) of 265 after 10 days in the MLE group, and in 11 (3.9%) of 285, 23 (7.7%) of 297, and 78 (26.4%) of 295 in the LE group, respectively (P=0.36). There were no significant differences in overall pain scores from any rating system or in the amount of analgesics used. CONCLUSION: Incidence and extent of pain in the first 10 days after LE correspond to those after adequately performed MLE.

CA125 and HE4 levels in a Czech female population diagnosed with endometrial cancer in preoperative management.

AIM: The aim of the present study was to compare the use of cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) biomarkers in patients with endometrial cancer for preoperative management and to particularly focus on relationship between CA125 and HE4 and disease stage in predicting myometrial invasion or intrauterine tumor spread. PATIENTS AND METHODS: Thirty-four patients diagnosed with endometrial cancer and 32 healthy controls were enrolled into the pilot study in the period between May 2012 and March 2013. Blood from all the females was collected and examined for CA125 and HE4. Based on standardized ultrasound examination, including gynecological examination, the clinical disease stage was determined. RESULTS: We found a significant difference (p<0.0001) for means of serum levels of HE4: females with endometrial cancer, 75.5 pmol/l, versus healthy females, 40.0 pmol/l. A non-significant statistical difference was found for mean serum CA125 levels (p=0.4442): females with endometrial cancer 19.0 IU/l, versus healthy females, 15 IU/l. A significant correlation with histopathological disease stage was found for both biomarkers (Spearman correlation). Sensitivity and specificity, and the related cut-off for HE4 suggest that HE4 would be a more appropriate biomarker for differential diagnosis between benign and malignant states. CONCLUSION: Based on our pilot study, we found that parallel examination of HE4 and CA125 may support endometrial ultrasound finding verification prior to biopsy. This study is ongoing and we expect that results on a larger population may enable HE4 measurement to be implemented in routine practice.

HE4 and ROMA index in Czech postmenopausal women.

AIM: The first aim of the project was to evaluate the benefits of the determination of human epididymis protein 4 (HE4) and the risk of ovarian malignancy algorithm (ROMA) index for primary detection of ovarian cancer in a population of Czech women. The second aim was to study the advantages HE4, cancer antigen 125 (CA125) and ROMA index for distinguishing between benign and malignant tumors. Aware of the age distribution of ovarian cancer, we focused on postmenopausal patients. PATIENTS AND METHODS: Our group of patients consisted of 256 females, 21 with ovarian cancer and 235 with benign ovarian tumors. All diagnoses were histologically verified. We determined the serum levels of HE4 and CA125 and calculated the ROMA2 index for postmenopausal women. Serum levels of the analytes were measured using an Architect 1000i instrument. Serum samples were collected prior to surgery or any other form of treatment and the results of the two groups of patients were compared (malignant vs. benign). RESULTS: There was a significant difference in the serum levels for all parameters studied between the groups of patients with malignant and those with benign diagnoses (Wilcoxon test, p<0.0001). When all parameters were evaluated at 95% specificity, the HE4 cut-off was 112 pmol/l at a sensitivity of 71.42%, a positive predictive value (PPV) of 55.56%, a negative predictive value (NPV) of 97.14% and an area under the curve (AUC) of 0.9152. The CA125 cut-off was 81 IU/l at a sensitivity of 80.95%, a PPV of 58.62%, a NPV of 98.23% and an AUC of 0.9731. ROMA2 index had a cut-off 37.70% at a sensitivity of 85.71%, a PPV of 62.06%, a NPV of 98.65% and an AUC of 0.9803. The highest diagnostic efficiency was achieved by the ROMA2 index. CONCLUSION: Determination of HE4 along with CA125 and ROMA2 index calculation is a suitable method for the improvement of the primary detection of ovarian cancer. This approach also improves the differential diagnostic possibilities for distinguishing between malignant and benign tumors.