Triple vs. single uterine tourniquet to reduce hemorrhage at myomectomy: a randomized trial.

PURPOSE: This study aimed to compare the effect of triple uterine tourniquet and single tourniquet on intraoperative blood loss during open myomectomy. METHODS: Women were randomized to undergo open myomectomy with a triple (n = 30) or single uterine tourniquet (n = 30). All symptomatic women aged 18-48 who had three or more myomas or at least one myoma greater than 8 cm if there were less than three myomas were eligible for the study. The primary outcome variable was the volume of intraoperative blood loss. The sample size was set to detect a 240 ml difference in blood loss with 80% power at α = 0.05, with an effect size of 0.8. The rate of transfusions, change in hemoglobin, volume of drains, operation time, tourniquet time, and perioperative complications were secondary outcomes. RESULTS: We found no significant difference in intraoperative blood loss between triple and single uterine tourniquets (527 [102-2931]) ml vs. 508 [172-2764] ml, p = 0.238). Between the single and triple tourniquet groups, the median weight of myoma (379 [136-3850] vs. 330 [140-1636] g, p = 0.451) and median number (1 [1-18] vs. 2 (1-13), p = 0.214), total operation time (84 ± 31 min vs. 79 ± 27 min, p = 0.503), ischemia time (35 ± 21 min vs. 30 ± 14 min., p = 0.238), drain volume at 48th hour (196 ± 89)ml vs. 243 ± 148 ml, p = 0.144) and decrease in hemoglobin (2.3 ± 1.8 g/dl vs. 2.8 ± 1.4 g/dl, p = 0.437) were similar. Eight (27%) patients in the triple tourniquet group and 12 (40%) patients in the single tourniquet group were transfused (p = 0.273). One patient underwent hysterectomy 6-8 h after myomectomy in a single tourniquet group. CONCLUSION: There was no clinically significant difference in intraoperative blood loss between triple and single uterine tourniquets during open myomectomy. CLINICAL TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ClinicalTrials.gov ID: NCT02392585, 03/13/2015.

New approach to the risk variables for administration of fibrinogen in patients with postpartum hemorrhage by using cluster analysis.

OBJECTIVE: To analyze all the variables in women who received fibrinogen for postpartum hemorrhage (PPH) using hierarchical cluster analysis, to provide greater insight into the risk variables involved in these women. METHODS: This retrospective study of women with at least 500 mL of bleeding at birth or during the postpartum period and treated with fibrinogen was conducted at the Department of Obstetrics and Gynecology, Atatürk University School of Medicine from January 2013 to January 2018. Data on the women were obtained from medical records and various risk variables were recorded and analyzed using hierarchical cluster analysis. RESULTS: A total of 114 women with PPH were included in the study. Based on a dendrogram, three main clusters of similar quality variables were created: 1) gravida, parity, age, cervical/vaginal hematoma, laparotomy, hypogastric artery ligation, uterine artery embolization, uterine artery ligation, uterine atony, distance from outer center, lowest hemoglobin, preoperative platelets, endometritis, preoperative white blood cells; 2) lowest fibrinogen, highest fibrinogen, type of birth, placenta invasion anomaly, Bakri balloon tamponade, postpartum hysterectomy, preoperative activated partial thromboplastin time (APTT), preoperative international normalized ratio (INR), placental abruption, in-utero ex fetus; 3) postoperative APTT, postoperative INR, maternal mortality, erythrocyte transfusion, plasma transfusion, hospital stay time, disseminated intravascular coagulation/HELLP syndrome, highest hemoglobin, blood group, postoperative platelets, platelet transfusion, pre-eclampsia/eclampsia, fibrinogen extract. CONCLUSION: According to the cluster analysis, we should keep fibrinogen extract in the foreground especially in the treatment of hemorrhage in patients with variable conditions. As a result, we can determine whether fibrinogen extract, which has a high economic cost, should be kept at each center. We can also direct which patient will be referred in accordance with the referral steps.

Fetus delivery time in extraperitoneal versus transperitoneal cesarean section: a randomized trial.

Objective: We compared the extraperitoneal cesarean section to transperitoneal cesarean on fetal delivery time.Material and methods: This randomized study included 210 pregnant women undergoing cesarean section for elective reasons, repeat cesarean (< four), or dystocia. Patients who required an urgent cesarean section, who were at high risk for obstetric or maternal bleeding, who had a uterine or adnexal mass, or who requested tubal ligation were excluded from the study. The primary outcome of the study was the skin incision-to-delivery time. The sample size was set to detect of 1-minute difference in fetal delivery time between groups (two-tailed hypothesis, α = 0.05, ß = 0.10). Secondary outcome measures were total operation time, intraoperative nausea, gag reflex, vomiting, pain and anxiety for those receiving regional anesthesia, postoperative pain, change in hemoglobin, postoperative analgesic requirements, nausea, vomiting and shoulder pain, urogenital distress, time until gas passage, and neonatal outcome.Results: No significant difference occurred between the two groups for skin incision-to- delivery time (extraperitoneal cesarean 3.9 minutes [2.1-7.3] versus transperitoneal cesarean 4.2 minutes [1.9-8.2], p = .065). Significant differences regarding intraoperative pain, total operation time, postoperative pain at the surgical site and shoulder pain, analgesic requirements, time until gas passage, and oral tolerability favored the extraperitoneal group. No significant differences between groups occurred regarding other seconder outcome parameters.Conclusions: There is no clinically significant difference between extraperitoneal cesarean section and transperitoneal cesarean on fetal delivery time. Extraperitoneal cesarean reduces postoperative pain, analgesic requirements, and improves oral tolerability.

Vaginal Misoprostol Compared With Buccal Misoprostol for Termination of Second-Trimester Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To compare the efficacy of vaginal misoprostol with buccal misoprostol for second-trimester termination of pregnancies. METHODS: In a randomized trial, we compared 400 micrograms vaginal and buccal misoprostol every 3 hours for up to six doses for induction of labor at 13-24 weeks of gestation with a live fetus and intact membranes. Women who had a uterine scar were excluded from the study. The primary outcome of the study was induction-to-abortion interval. Based on a two-tailed α of 0.05, we planned to include 65 patients per group to detect a 50% difference in the primary outcome with a power of 80%. RESULTS: From January 2014 to December 2014, 172 women were screened and 130 were randomized: 65 vaginal and 65 buccal misoprostol. Characteristics of patients were similar between groups. Patients administered vaginal misoprostol compared with buccal misoprostol had a shorter induction-to-abortion interval (25±17 hours compared with 40±29 hours, P=.001) and a higher abortion rate within both 24 hours (41 [63%] compared with 27 [42%] P=.014) and 48 hours (59 [91%] compared with 44 [68%], P=.001). Complete abortion rates were similar in both groups (vaginal 51 [78%] compared with buccal 54 [83%]). The incidence of side effects was similar for both groups. The perceived pain was higher in the buccal group, but the small difference did not appear to be clinically meaningful. CONCLUSION: Vaginal compared with buccal misoprostol administration has a shorter induction-to-abortion interval for second-trimester termination of viable pregnancies. However, both administration routes are equally effective for induction of termination. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT02048098. LEVEL OF EVIDENCE: I.

Intravenous versus oral iron for treatment of anemia in pregnancy: a randomized trial.

OBJECTIVE: The aim of this study was to compare the efficacy of intravenous iron to oral iron in the treatment of anemia in pregnancy. METHODS: In this randomized open-label study, 90 women with hemoglobin levels between 8 and 10.5 g/dL and ferritin values less than 13 microg/L received either oral iron polymaltose complex (300 mg elemental iron per day) or intravenous iron sucrose. The iron sucrose dose was calculated from the following formula: weight before pregnancy (kg) x (110 g/L - actual hemoglobin [g/L]) x 0.24 + 500 mg. Treatment efficacy was assessed by measuring hemoglobin and ferritin on the 14th and 28th days and at delivery, and the hemoglobin on the first postpartum day. Adverse drug reactions, fetal weight, hospitalization time, and blood transfusions were also recorded. RESULTS: Hemoglobin values varied significantly with time between groups (interaction effect, P < .001). The change in hemoglobin from baseline was significantly higher in the intravenous group than the oral group at each measurement; the changes with respect to subsequent hemoglobin were significantly higher on the 14th (P = .004) and 28th (P = .031) days. Ferritin values were higher in patients receiving intravenous iron throughout pregnancy. No serious adverse drug reactions were observed. Fetal weight and hospitalization time were similar in the 2 groups. Blood transfusion was required for only one patient in the oral group. CONCLUSION: Intravenous iron treated iron-deficiency anemia of pregnancy and restored iron stores faster and more effectively than oral iron, with no serious adverse reactions.

Random urine protein-creatinine ratio to predict proteinuria in new-onset mild hypertension in late pregnancy.

OBJECTIVE: The aim of this study was to evaluate the diagnostic accuracy of random urine protein-creatinine ratio for prediction of significant proteinuria (> or = 300 mg/24 h) in patients with new-onset mild hypertension in late pregnancy. METHODS: Medical records of 185 consecutive pregnant patients with new onset of mild hypertension in late pregnancy were reviewed. Random urine samples were taken before 24-hour urine collection. The predictive values of the random urine protein-creatinine ratio for diagnosis of significant proteinuria were estimated by using at least a 300-mg protein level within the collected 24-hour urine as the gold standard. RESULTS: Thirty-nine patients (21%) had significant proteinuria. There was a significant association between 24-hour protein excretion and the random urine protein-creatinine ratio (rs = 0.56, P <.01). With a cutoff protein-creatinine ratio greater than 0.19 as a predictor of significant proteinuria, sensitivity and specificity were 85% and 73%, respectively. Positive and negative predictive values of the test were 46% and 95%, respectively. CONCLUSION: The random urine protein-creatinine ratio was a poor predictor for significant proteinuria in patients with new-onset mild hypertension in late pregnancy.