Preoperative predictors of pelvic and para-aortic lymph node metastases in cervical cancer.

AIM: This study investigated potential preoperative predictors of pelvic lymph node (PLN) and para-aortic LN (PaLN) involvement in cervical cancer (CC). MATERIALS AND METHODS: This study retrospectively analyzed 283 patients diagnosed with early (stage IA1-IIA) CC who underwent retroperitoneal LN dissection between January 1992 and February 2015. Several risk factors that are believed to influence PLN and PaLN involvement in CC were analyzed as follows: age >50 years, lymphovascular space invasion (LVSI), tumor size ≥2 cm, hemoglobin <12 g/dL, and nonsquamous cell histologic type. RESULTS: LVSI (odds ratio [OR] = 11.3, 95% confidence interval [CI] = 5.2-24.3) and tumor size (OR = 3.2, 95% CI = 1.4-7.2) were independent predictors of PLN involvement. None of the factors predicted PaLN involvement in a regression analysis. However, all nine patients who had PaLN involvement also had PLN involvement. CONCLUSION: LVSI and tumor size independently increase the risk of PLN involvement.

A novel preoperative scoring system based on 18-FDG PET-CT for predicting lymph node metastases in patients with high-risk endometrial cancer.

The purpose of this study was to develop a model predicting the probability of pelvic-paraaortic node metastases in high-risk endometrial cancer patients. This trial included 41 high-risk endometrial cancer patients. All of the patients underwent an 18-FDG PET-CT followed by surgical staging, including a pelvic and paraaortic lymphadenectomy. We developed a useful scoring system combining weighted risk factors derived from a regression model: (3 × presence PET-CT involvement) + (3 × PET-CT maximum standardised uptake value ≥20) + (2 × diabetes comorbidity) + (1 × age ≥60 years) + (1 × body mass index ≥30). The area under the curve of the resulting score was 0.848. There was 75% sensitivity, 89% specificity and a 75% positive predictive value and 89% negative predictive value when a score of 6 was used as the cut-off. Our novel preoperative scoring system is an accurate method for the preoperative evaluation of lymph node metastases, and thus will aid gynaecological oncologists in selecting EC patients who may benefit from a lymphadenectomy. Impact statement What is already known on this subject? Endometrial cancer (EC) is a common gynaecological malignancy. Surgical staging is currently the standard treatment and the gold standard for evaluating lymph node metastases (LNm) is a surgical assessment (Chan et al. 2006 ). Three previous randomised clinical studies failed to find a clear therapeutic role for the lymphadenectomy; thus, the utility of this surgical procedure in high-risk early-stage EC remains under debate (Benedetti Panici et al. 2008 ; Kitchener et al. 2009 ; Signorelli et al. 2015 ). Non-invasive techniques that accurately identify lymph node metastases would reduce costs and complications. What do the results of this study add? Our developed novel scoring system that is based on positron emission tomography-computer tomography (PET-CT) with 2-deoxy-2-(18F) flouro-2-D-glucose (FDG) may facilitate the identification of patients at an increased risk of LNm. What are the implications of these finding for clinical practice and/or further research? This study shows that our novel preoperative scoring system provides an accurate method for the preoperative evaluation of LNm, and thus could guide gynaecologic oncologists in selecting the high-risk endometrial cancer patients who may benefit from a systematic lymphadenectomy. Further larger, prospective studies are needed to confirm the accuracy and the feasibility of our scoring system.

Isolated pulmonary metastases in patients with cervical cancer and the factors affecting survival after recurrence.

OBJECTIVES: The aim of this study was to assess the treatment options and survival of uterine cervical cancer (UCC) patients who develop isolated pulmonary metastases (IPM) and to establish risk factors for IPM. MATERIAL AND METHODS: Data from patients diagnosed with UCC between June 1991 and January 2017 at the Gynecological Oncology Department, Tepecik Training and Research Hospital, were investigated. In total, 43 cases with IPM were evaluated retrospectively. Additionally, 172 control patients diagnosed with UCC without recurrence were matched according to the International Federation of Gynecology and Obstetrics (FIGO) 2009 stage when the tumor was diagnosed. They wereselected using a dependent random sampling method. RESULTS: Of the 890 patients with UCC, 43 (4.8%) had IPM. The presence of lymphovascular space invasion (LVSI) and a mid-corpuscular volume (MCV) < 80 fL were statistically significant prognostic factors for IPM development in UCC patientsaccording to univariate regression analyses, and the presence of LVSI, a hemoglobin level < 12 g/dL, and an MCV < 80 fLwere statistically significant according to the multivariate regression analyses. We were unable to assess the role of lymph node status (involvement or reactive) as a prognostic factor in the development of IPM, because only seven patients (16.2%) in the case group underwent lymph node dissection. CONCLUSIONS: IPM typically develops within the first 3 years after the diagnosis of UCC, and survival is generally poor. An MCV < 80 fL and the presence of LVSI are significant risk factors for IPM development.

Management of Vertebral Metastasis in Patients With Uterine Cervical Cancer.

AIM: We sought to identify risk factors and management options for uterine cervical cancer (UCC) patients with a vertebral metastasis (VM) treated over the course of 23 years. METHODS: Among 844 UCC patients, 18 were diagnosed with a VM. Thirty-six control patients with UCC but without recurrence were matched to these 18 in terms of stage and histological tumor type using a dependent random sampling method. A logistic regression analysis was used to identify factors prognostic of VM; the results are presented as odds ratios with 95% confidence intervals (CIs). RESULTS: The mean survival time after VM treatment commenced was 12.1 ± 2.7 months (95% CI, 5.3-12.6 months) in patients who received chemotherapy (CT) and 15.0 ± 2.3 months (95% CI, 9.7-14.2 months) in those treated via chemoradiotherapy (CRT) (P = 0.566). In patients who underwent CT, the 1- and 2-year survival rates after recurrence were 19.2% and 0%, respectively. However, these figures were 50% and 8.3% in those treated via CRT. Both lymphovascular space invasion and mean corpuscular volume were risk factors for VM. Cox regression analysis showed that these prognostic factors had no effect on survival duration after recurrence. The locations and percentages of vertebra metastasis were as follows: 11.1% lumbar 4, 27.7% lumbar 5, 22.2% lumbar 4-5, 16.7% lumbar 3-4-5, 5.6% lumbar 2-3, 5.6% lumbar 2-3-4, 5.6% lumbar 3-4-5/sacral 1, and 5.6% thoracic 11-12/lumbar 1-2. CONCLUSIONS: We found that patients with lymphovascular space invasion were at high risk of isolated VM and that the survival times after CT and CRT were similar. Because most VMs are seen in the vertebral space within the borders of radiation therapy, borders of external beam radiotherapy should be carefully determined for each patient.

Is the measurement of the size of uterine lesions with positron emission tomography consistent in pre- and postmenopausal periods in endometrioid-type endometrial cancer?

OBJECTIVE: We aimed to investigate the correlation of the size and volume of uterine tumors obtained using positron emission tomography/computed tomography (PET/CT) and pathology specimens in patients with endometrioid-type endometrial cancer (EEC) in the premenopausal period, and to compare the results with those of postmenopausal women. In the premenopausal period, the endometrium uses more glucose than in the postmenopausal period. Therefore, the measurement of uterine tumor size using PET/CT in the premenopausal period may normally be different. MATERIALS AND METHODS: In this retrospective study, we reviewed the records of patients who were diagnosed as having EEC and underwent hysterectomy. Only patients who underwent preoperative PET/CT imaging were included in the study. The thickness and volume of the uterine lesion, and its maximum standardized uptake value as obtained using PET/CT and hysterectomy pathology specimens were recorded. RESULTS: Tumor size (p=0.051) and volume (p=0.404) were not found to be correlated with the imaging method used in premenopausal women and pathologic specimens. However, there was a correlation in postmenopausal women (p<0.001 for tumor size and p<0.001 for tumor volume). PET/CT has higher sensitivity, specificity, and positive predictive value in the postmenopausal period in the detection of >20 mm uterine tumors. CONCLUSION: PET/CT has a limited role in the measurement of the size of uterine lesions in all patients, especially in the premenopausal period; therefore, we recommend that frozen-section examinations be used intraoperatively to decide on lymph node dissection.

MELF Pattern for Predicting Lymph Node Involvement and Survival in Grade I-II Endometrioid-type Endometrial Cancer.

The aim of this study was to examine the associations between microcystic, elongated, and fragmented (MELF) pattern and other prognostic factors and lymph node involvement, disease-free survival, and overall survival (OS) using a case-control group consisting of grade I-II endometrioid endometrial carcinoma (EEC) patients with/without lymph node involvement. The files of the patients were searched electronically for all hysterectomy specimens with a diagnosis of grade I-II EEC of the uterine body from January 1, 2008 to July 31, 2014. Lymph node involvement was detected in 27 patients who were histologically diagnosed with grade I-II EEC, and these patients made up the case group. Using a dependent random sampling method, 28 grade I-II EEC patients without lymph node involvement were selected. According to multivariate regression analysis, lymphovascular space invasion [odds ratio, 23.5; 95% confidence interval (CI), 2.4-223.5] and MELF pattern (odds ratio, 13.3; 95% CI, 1.4-121.8) were significant predictors of lymph node involvement. There was recurrence in 15.8% of cases that showed a MELF pattern and in 19.4% of those that did not (P=0.738). According to Kaplan-Meier analysis, the MELF pattern revealed no significant differences in disease-free survival (hazard ratio, 1.0; 95% CI, 0.1-36.5), whereas the effect on OS was significant (hazard ratio, 2.2; 95% CI, 1.3-4.2). The presence of MELF pattern was a substantial risk factor for detecting lymph node involvement in patients with grade I-II EEC. The MELF pattern may be important for identifying which patients need staging surgery, in addition to its effect on the OS.

Stage IB1 cervical cancer treated with modified radical or radical hysterectomy: does size determine risk factors?

OBJECTIVES: This study was performed to investigate prognostic factors status at smaller tumors in patients with stageIB1 cervical cancer (CC) who underwent modified radical or radical hysterectomy. MATHERIAL AND METODS: Data from patients diagnosed with CC between January 1995 and January 2017 at the GynecologicalOncology Department, Tepecik Training and Research Hospital and Bakirkoy Dr. Sadi Konuk Training and Research Hospital,Istanbul, Turkey, were investigated. A total of 182 stage IB1 CC cases were evaluated retrospectively. RESULTS: Patients were divided into two groups according to tumor size (< 2 cm and ≥ 2 cm). There were no complicationsassociated with the operation in patients with a tumor size < 2 cm. Among patients with a tumor size ≥ 2 cm, however, 0.9% (n = 1) developed bladder laceration, 0.9% (n = 1) rectum laceration, and 0.9% (n = 1) pulmonary emboli (P = 0.583). The rates of intermediate risk factors (depth of stromal invasion and lymphovascular space invasion) were significantly higher and lymph node involvement significantly more frequent in patients with a tumor size ≥ 2 cm. However, there were no significant differences in parametrial invasion or vaginal margin involvement between the two groups. CONCLUSIONS: Intermediate risk factors and lymph node metastasis were significantly less frequent in patients with small tumors measuring < 2 cm. However, although parametrial involvement and vaginal margin involvement were less common in patients with small tumors compared with large tumors (≥ 2 cm), the differences were not significant.

The Impact of Surgical Staging on the Prognosis of Mucinous Borderline Tumors of the Ovaries: A Multicenter Study.

BACKGROUND/AIM: The purpose of this study was to prove the effect of complete surgical staging of patients with mucinous borderline ovarian tumors (mBOTs) especially appendectomy on progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: The database of 14 gynecological oncology departments from Turkey and Germany were comprehensively searched for women who underwent primary surgery for an ovarian tumor between January 1, 1998, and December 31, 2015, and whose final diagnosis was mBOT. RESULTS: A total of 364 patients with mBOT with a median age of 43.1 years were included in this analysis. The median OS of all patients was 53.1 months. The majority of cases had Stage IA (78.6%). In univariate and multivariate analyses, radical surgery, omentectomy, appendectomy, lymphadenectomy, and adding adjuvant chemotherapy were not independent prognostic factors for PFS and OS. Furthermore, FIGO stage (≥IC vs.

Does BLOODCARE Powder Prevent Postoperative Chylous Ascites After Lymphadenectomy for Gynecological Malignancies?

OBJECTIVE: The aim of this study was to evaluate the effect of an intraoperative hemostatic cellulose agent (BLOODCARE powder [Life Line, Brno, Czech Republic]) on reducing the incidence of postoperative chylous ascites (PCA) after complete pelvic and para-aortic lymphadenectomy (PPALN) in patients with gynecological cancers treated with laparotomy. METHODS: This case control study reviewed 150 patients with gynecological cancer who underwent PPALN. In the study group (n = 75), BLOODCARE powder was applied below the left renal vein and bilateral obturator fossa. In the control group (n = 75), no sealant agent was used after the procedure, such as fibrin glue or a hemostatic cellulose agent. RESULTS: The demographic and surgical characteristics of the patients in both groups were similar. Chylous ascites occurred in 9 cases (6%). The incidence of PCA was lower in the study group (1 [1.3%] vs 8 [10.7%]; P = 0.03). Logistic regression analysis indicated that using BLOODCARE powder during the surgery independently protected against the development of PCA. CONCLUSIONS: Using BLOODCARE powder during retroperitoneal surgery may prevent PCA. This simple, effective agent should be used after PPALN for gynecological cancers.

Comparison Of Early-Stage High-Grade Serous Primary Fallopian Tube Cancers and Epithelial Ovarian Cancers: A Multicenter Study.

INTRODUCTION: We compared the disease free-survival (DFS) and overall survival (OS) rates of patients with high-grade serous primary fallopian tube cancer (HG-sPFTC) and high-grade serous epithelial ovarian cancer (HG-sEOC). METHODS: 22 early-stage cancer patients (International Federation of Gynecology and Obstetrics (FIGO) stages I-II) with HG-sPFTC were retrospectively evaluated. In addition, 44 control patients diagnosed with HG-sEOC were matched to these patients with respect to tumor stage at diagnosis. All patients underwent complete surgical staging, followed by adjuvant chemotherapy. Kaplan-Meier curves were used to generate survival data. RESULTS: The mean age of HG-sPFTC patients was 59.4 ± 6.2 years, and that of HG-sEOC patients 55.2 ± 11.0 years (p = 0.002). All patients underwent 6 cycles of platinum-based adjuvant chemotherapy. All operations were optimal. The 5-year DFSs were 77.3% for HG-sPFTC patients and 75% for HG-sEOC patients (p = 1.00).The 5-year OS rates were 81.8% in women with HG-sPFTC and 77.3% in those with HG-sEOC (p = 0.75). CONCLUSION: The DFS and OS rates of patients with early-stage (FIGO stages I and II) HG-sPFTC and HG-sEOC were similar. The surgical and adjuvant therapy management of these malignancies should be similar.

Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial.

BACKGROUND: Paralytic ileus that develops after elective surgery is a common and uncomfortable complication and is considered inevitable after an intraperitoneal operation. OBJECTIVE: The purpose of this study was to investigate whether coffee consumption accelerates the recovery of bowel function after complete staging surgery of gynecologic cancers. STUDY DESIGN: In this randomized controlled trial, 114 patients were allocated preoperatively to either postoperative coffee consumption with 3 times daily (n=58) or routine postoperative care without coffee consumption (n=56). Total abdominal hysterectomy and bilateral salpingo-oophorectomy with systematic pelvic and paraaortic lymphadenectomy were performed on all patients as part of complete staging surgery for endometrial, ovarian, cervical, or tubal cancer. The primary outcome measure was the time to the first passage of flatus after surgery. Secondary outcomes were the time to first defecation, time to first bowel movement, and time to tolerance of a solid diet. RESULTS: The mean time to flatus (30.2±8.0 vs 40.2±12.1 hours; P<.001), mean time to defecation (43.1±9.4 vs 58.5±17.0 hours; P<.001), and mean time to the ability to tolerate food (3.4±1.2 vs 4.7±1.6 days; P<.001) were reduced significantly in patients who consumed coffee compared with control subjects. Mild ileus symptoms were observed in 17 patients (30.4%) in the control group compared with 6 patients (10.3%) in the coffee group (P=.01). Coffee consumption was well-tolerated and well-accepted by patients, and no intervention-related side-effects were observed. CONCLUSION: Coffee consumption after total abdominal hysterectomy and systematic paraaortic lymphadenectomy expedites the time to bowel motility and the ability to tolerate food. This simple, cheap, and well-tolerated treatment should be added as an adjunct to the postoperative care of gynecologic oncology patients.

Management of Isolated Vaginal Metastasis in Squamous Cell Cervical Cancer: 23 Years' Experience at a Single Center.

AIM: The aim of this study was to investigate the treatment options and survival of cervical cancer (CC) patients who develop isolated vaginal metastasis (IVM), and to establish risk factors for IVM. PATIENTS AND METHODS: A total of 21 cases with IVM were evaluated retrospectively. In addition, 42 control patients diagnosed with CC without recurrence were matched. Tumor size, depth of stromal invasion (DOI), lymphovascular space invasion (LVSI), and size of vaginal and lymph node metastases were analyzed in accordance with the pathology reports. Patients who had IVM were investigated in terms of treatment options (chemotherapy (CT), radiotherapy (RT), or chemoradiotherapy (CRT)) and survival. RESULTS: After detection of IVM, the 1-, 3-, and 5-year survival rates were 57.1, 23.8, and 9.5%, respectively. The mean survival time after metastasis detection was 23.1 ± 31.3 months. LVSI, DOI ≥ 1/2, hemoglobin < 12 g/dl, postmenopausal status, and tumor size ≥ 4 cm were independent risk factors for IVM. The 5-year survival rates were 30.0% for patients receiving RT, 17.1% for patients receiving CRT, and 0% for patients receiving CT. CONCLUSION: IVM typically develops within the first 2 years after the diagnosis of CC, and survival is generally poor. RT was the most effective treatment in patients with IVM.

Borderline ovarian tumors: clinical characteristics, management, and outcomes - a multicenter study.

BACKGROUND: The optimal surgical management and staging of borderline ovarian tumors (BOTs) are controversial. Institutions have different surgical approaches for the treatment of BOTs. Here, we performed a retrospective review of clinical characteristics, surgical management and surgical outcomes, and sought to identify variables affecting disease-free survival (DFS) and overall survival (OS) in patients with BOTs. METHODS: A retrospective review of ten gynecological oncology department databases in Turkey was conducted to identify patients diagnosed with BOTs. The effects of type of surgery, age, stage, surgical staging, complete versus incomplete staging, and adjuvant chemotherapy were examined on DFS and OS. RESULTS: In total, 733 patients with BOTs were included in the analysis. Most of the staged cases were in stage IA (70.4 %). In total, 345 patients underwent conservative surgeries. Recurrence rates were similar between the conservative and radical surgery groups (10.5 % vs. 8.7 %). Furthermore we did not find any difference between DFS (HR = 0.96; 95 % confidence interval, CI = 0.7-1.2; p = 0.576) or OS (HR = 0.9; 95 % CI = 0.8-1.1; p = 0.328) between patients who underwent conservative versus radical surgeries. There was also no difference in DFS (HR = 0.74; 95 % CI = 0.8-1.1; p = 0.080) or OS (HR = 0.8; 95 % CI = 0.7-1.0; p = 0.091) between complete, incomplete, and unstaged patients. Furthermore, receiving adjuvant chemotherapy (CT) for tumor stage ≥ IC was not an independent prognostic factor for DFS or OS. CONCLUSIONS: Patients undergoing conservative surgery did not show higher recurrence rates; furthermore, survival time was not shortened. Detailed surgical staging, including lymph node sampling or dissection, appendectomy, and hysterectomy, were not beneficial in the surgical management oF BOTs.

Does vitamin C and vitamin E supplementation prolong the latency period before delivery following the preterm premature rupture of membranes? A randomized controlled study.

OBJECTIVE: To determine whether maternal vitamin C and vitamin E supplementation after the premature rupture of membranes is associated with an increase in the latency period before delivery. METHODS: In the present prospective open randomized trial, 229 pregnant women with preterm premature rupture of membranes (PPROM) at ≥ 24.0 and < 34.0 weeks' gestation were randomly assigned to receive either 1,000 mg of vitamin C and 400 IU of vitamin E (n = 126) or a placebo (n = 123). The primary outcome was the latency period until delivery. Analysis was performed on an intention-to-treat basis. RESULTS: No significant differences in demographic or clinical characteristics were observed between the groups. Latency period until delivery was significantly higher in the group that received vitamins compared with the control group (11.2 ± 6.3 days versus 6.2 ± 4.0 days; p < 0.001). Gestational age at delivery was also significantly higher in the vitamin group compared with the control group (31.9 ± 2.6 weeks versus 31.0 ± 2.6 weeks; p = 0.01). No significant differences in adverse maternal outcome (i.e., chorioamnionitis or endometritis) or neonatal outcome (i.e., neonatal sepsis, neonatal death, necrotizing enterocolitis, or grade 3 to 4 intraventricular hemorrhage) were noted between groups. CONCLUSIONS: The findings of the present study suggest that the use of vitamins C and E in women with PPROM is associated with a longer latency period before delivery. Moreover, adverse neonatal and maternal outcomes, which are often associated with prolonged latency periods, were similar between the groups.

Unintended extension of the lower segment uterine incision at cesarean delivery: a randomized comparison of sharp versus blunt techniques.

OBJECTIVE: This study compared two methods of expanding the uterine incision at the time of cesarean delivery, which is associated with the risk of unintended extension. STUDY DESIGN: This randomized trial included 1,076 women who underwent elective cesarean delivery. The primary outcome measure was the incidence of unintended extension related to the method used for expanding the uterine incision. RESULTS: Participants in both groups (blunt vs. sharp) had similar demographic and clinical characteristics. The incidence of unintended extension (8.8% vs. 4.8%; p = 0.009), mean estimated blood loss (853.67 ± 42 mL vs. 664.80 ± 38 mL; p = 0.001), and blood loss >1000 mL (11.4% vs. 6.8%; p = 0.009) was significantly higher in the sharp group compared with the blunt group. No difference in transfusions (7.5% vs. 6.3%; p = 0.440) or the need for additional supertonic agents (16% vs. 12.9%; p = 0.144) was noted. CONCLUSION: Sharp expansion of the uterine incision was related to a higher risk of unintended extension and maternal blood loss. Because blunt expansion is associated with a lower risk for unintended extension and maternal blood loss, it should be the first option during elective cesarean delivery.

HELLP syndrome: 8 years of experience from a tertiary referral center in western Turkey.

OBJECTIVE: This study was performed to determine the incidence, symptomatology, complications, mode of delivery, treatment modalities, and risk factors for maternal outcome and perinatal outcome in women with HELLP syndrome. METHODS: A total of 303 pregnancies with hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome diagnosed antenatally were reviewed between 2002 and 2009. Demographic data, including age, parity, gestational age, and clinical and laboratory findings, were recorded from the medical files. In addition, delivery route, indication of cesarean section, and fetal and maternal complications were determined. RESULTS: Acute renal failure (20.5%) was the most common complication. Eclampsia was present in 303 women with HELLP syndrome (52%). There were four maternal deaths (1.4%). The perinatal mortality rate was 20.3%. The percentages of intracerebral hemorrhage and maternal death were higher in women with eclampsia than in those without (6.3% vs. 0.8%, p = 0.01 and 4.8% vs. 0.4%, p = 0.02, respectively). A nadir platelet count of ≤50,000 cells/mm(3), a peak serum AST of >150 IU/L, and a peak serum LDH of ≥1400 IU/L were not independent risk factors of an adverse outcome. CONCLUSION: We concluded that the incidence rates of serious maternal and fetal morbidities and mortalities are increased in HELLP syndrome. Laboratory parameters of HELLP syndrome are not independent risk factors for adverse neonatal-maternal outcome. Adequate and prompt diagnosis and management are crucial in patients with HELLP syndrome.

Labor induction in term premature rupture of membranes: comparison between oxytocin and dinoprostone followed 6 hours later by oxytocin.

OBJECTIVE: The aim of this randomized study was to compare 2 protocols for inducing labor in women with premature rupture of membranes (PROM) at term. STUDY DESIGN: Women with PROM and a Bishop score ≤5 were randomly assigned to receive either an intravenous oxytocin infusion (n = 223) or a dinoprostone pessary followed 6 hours later by an intravenous oxytocin infusion (n = 227). RESULTS: Vaginal delivery within 24 hours of labor induction increased significantly with sustained-released dinoprostone followed by oxytocin infusion (78.5% vs 63.3%; relative risk, 1.23; 95% confidence interval, 1.09-1.39; P = .001). Maternal and neonatal outcomes were similar between the groups. CONCLUSION: Sustained-released dinoprostone followed 6 hours later by an oxytocin infusion in term women with PROM was associated with a higher rate of vaginal delivery within 24 hours, and no difference in maternal-neonatal complications was observed compared with oxytocin infusion alone.

Is post-partum oxygen inhalation useful for reducing vaginal blood loss during the third and fourth stages of labour? A randomised controlled study.

OBJECTIVE: To determine the effectiveness of oxygen inhalation after delivery in reducing vaginal blood loss during the third and fourth stages of labour. METHODS: In this prospective randomised trial, 450 women undergoing vaginal delivery who did not have risk factors for post-partum haemorrhage were randomly assigned to receive either 8 L/min O(2) via a face mask for 2 h (n = 214) or normally breathe room air after the delivery (n = 216). The oxygen was given to the women after delivering their babies. Active management of the third stage of labour was used in both groups. The primary outcome was mean blood loss during the third and fourth stages of labour. RESULTS: No differences in demographic or clinical characteristics were observed between groups. The mean estimated blood loss at the third and fourth stages of labour did not significantly differ between the control and oxygen-inhalation groups (294.5 ± 179.7 vs 273.4 ± 146.6 mL, respectively; P = 0.18). In addition, there was no significant difference in the proportion of women who experienced an estimated blood loss >500 mL or the percentage of women who needed additional uterotonic agents (11 [5.1%] vs 9 [4.2%], respectively; RR 1.2 95% CI 0.5-2.8; P = 0.82 and 12 [5.6%] vs 8 [3.7%], respectively; RR 1.4 95% CI 0.6-3.5; P = 0.49). CONCLUSION: Post-partum oxygen inhalation is not beneficial for reducing vaginal blood loss during the third and fourth stages of labour.

Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study.

We sought to determine the efficacy and safety of tranexamic acid (TA) in reducing blood loss during elective cesarean section (CS). We performed a randomized, double-blind, placebo-controlled study of 660 women who underwent elective CS. The patients were randomly selected to receive an intravenous infusion of either TA (1 g/10 mL in 20 mL of 5% glucose; N = 330) or 30 mL 5% glucose prior to surgery. The primary outcome was the estimated blood loss following CS. No demographic difference was observed between groups. The mean estimated blood loss was significantly lower in women treated with TA compared with women in the placebo group (499.9 ± 206.4 mL versus 600.7 ± 215.7 mL, respectively; P < 0.001), and the proportion of women in the TA group who had an estimated blood loss >1000 mL was significantly lower than in the placebo group (7 [2.1%] versus 19 [5.8%], respectively; relative risk [RR] 2.7; 95% confidence interval [CI] 1.1 to 6.3; P < 0.03). Furthermore, more women in the placebo group than in the TA group required additional uterotonic agents (48 [14.5%] versus 28 [8.5%], respectively; RR 1.7; 95% CI 1.1 to 2.6; P = 0.02). Maternal and neonatal outcomes did not differ significantly. TA significantly reduced bleeding during CS, the percentage of patients with blood loss >1000 mL, and the need for additional uterotonic agents. Furthermore, the incidence of thromboembolic events did not increase. Our results suggest that TA can be used safely and effectively to reduce CS bleeding.

Sustained-release dinoprostone vaginal pessary with concurrent high-dose oxytocin infusion compared to sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for labor induction in women at term with unfavorable cervix: a randomized controlled trial.

OBJECTIVE: To compare the efficacy and safety of sustained-release dinoprostone vaginal pessary and concurrent high-dose oxytocin infusion with sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for cervical ripening and labor induction. METHODS: A total of 500 nulliparous or multiparous women with a singleton pregnancy, Bishop score ≤4 and admitted for labor induction. Women were randomly assigned to induction of labor using intravaginal dinoprostone with concurrent high-dose oxytocin (n = 250) or intravaginal dinoprostone pessary followed 6 h later by high-dose oxytocin (n = 250). The primary outcome was the number of vaginal deliveries achieved within 24 h of labor induction. RESULTS: Baseline characteristics of both groups were comparable. Vaginal delivery within 24 h of labor induction was significantly increased with sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion (92.8 vs. 82.0%, RR 2.82, 95% CI 1.58-5.04). There were more cesarean section deliveries in the dinoprostone with concurrent high-dose oxytocin group (16.8 vs. 6.8%, RR 0.36, 95% CI 0.20-0.65). Maternal outcomes did not differ significantly. An Apgar score of <7 at 5 min was found more often in the dinoprostone with concurrent high-dose oxytocin group (3.6%) in comparison to dinoprostone pessary followed 6 h later by high-dose oxytocin (0.8%), although this was not statistically different (RR 0.21, 95% CI 0.04-1.01). CONCLUSION: Sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion appears to be safer and more effective than sustained-release dinoprostone with concurrent high-dose oxytocin infusion in achieving cervical ripening and successful vaginal delivery.