Pharmacokinetics of Curative Tranexamic Acid in Parturients Undergoing Cesarean Delivery
The aim of this study was to evaluate the population pharmacokinetics of tranexamic acid (TXA) administered intravenously at a single dose of 0.5 or 1 g in parturients undergoing active hemorrhagic cesarean delivery and to evaluate the influence of patient variables on TXA pharmacokinetics. Subjects from three recruiting centers were included in this PK sub-study if randomized in the experimental group (i.v TXA 0.5 g or 1 g over one minute) of the TRACES study. Blood samples and two urinary samples were collected within 6 h after TXA injection. Parametric non-linear mixed-effect modeling (Monolix v2020R1) was computed. The final covariate model building used 315 blood and 117 urinary concentrations from seventy-nine patients. A two-compartment model with a double first-order elimination from the central compartment best described the data. The population estimates of clearance (CL), central volume of distribution (V1), and half-life for a typical 70 kg patient with an estimated renal clearance of 150 mL/min (Cockroft-Gault) were 0.14 L/h, 9.25 L, and 1.8 h. A correlation between estimated creatinine clearance and CL, body weight before pregnancy, and V1 was found and partly explained the PK variability. The final model was internally validated using a 500-run bootstrap. The first population pharmacokinetic model of TXA in active hemorrhagic caesarean section was successfully developed and internally validated.
Colloid coload versus crystalloid coload to prevent maternal hypotension in women receiving prophylactic phenylephrine infusion during caesarean delivery: a randomised controlled trial
International journal of obstetric anesthesia. 2022;49:103246
BACKGROUND The optimal fluid strategy to prevent maternal hypotension during caesarean delivery remains unclear. This study aim was to compare the incidence of post-spinal anaesthesia hypotension in women receiving either colloid or crystalloid coload in the setting of prophylactic phenylephrine infusion during caesarean delivery. METHODS Healthy mothers undergoing elective caesarean delivery under spinal anaesthesia were randomised to receive a rapid intravenous coload with 6% hydroxyethyl starch 130/0.4 10 mL/kg (colloid group) or balanced crystalloid solution (Plasma Solution A) 10 mL/kg (crystalloid group) during spinal anaesthesia. All women had a prophylactic phenylephrine infusion initiated at 25 μg/min immediately after the subarachnoid block and titrated to systolic blood pressure using a standardised protocol. The primary outcome was the incidence of hypotension (systolic blood pressure <80% of baseline) until delivery. RESULTS The incidence of hypotension was 50% in the colloid group and 62% in the crystalloid group (absolute difference, -12% [95% CI -33% to 9%]; relative risk, 0.8 [95% CI 0.56 to 1.14]; P=0.314). No significant difference between groups was found in the number of hypotensive episodes (median 0.5 [IQR 0 to 1] vs 1 [0 to 2], P=0.132) or phenylephrine dose (675 [IQR 425 to 975] μg vs 750 [625 to 950] μg, P=0.109). The incidence of severe hypotension, symptomatic hypotension, bradycardia, nausea, and the neonatal outcomes were not significantly different. CONCLUSIONS This study found no benefit of colloid coload compared with crystalloid coload for preventing maternal hypotension in the presence of prophylactic phenylephrine infusion during caesarean delivery.
The safty profile of blood salvage applied for collected blood with amniotic fluid during cesarean section
BMC pregnancy and childbirth. 2022;22(1):160
BACKGROUND The guidelines of National Health Service(NHS, the United Kingdom) recommended for use in obstetrics at increased risk of bleeding, requiring two suction devices to reduce amniotic fluid contamination, however, when comes to massive hemorrhage, it is may difficult to operate because the complex operation may delay time. The aim of the study was to detect the effect of amniotic fluid recovery on intraoperative cell salvage in obstetrics and provide evidence for clinical applications. METHOD Thirty-four patients undergoing elective cesarean section were randomly divided into two groups. In group 1, the cumulative blood from the operation field, including the amniotic fluid, was collected using a single suction device for processing. In group 2, after suctioning away the amniotic fluid using another suction device for the cumulative blood from the operation field. From each group, four samples were taken, including maternal venous blood (sample I), blood before washing (sample II), blood after washing (sample III) and blood after filtration with a leukocyte filter (sample IV), to detect serum potassium (K +), hemoglobin (Hb), white blood cell (WBC), fetal hemoglobin (HbF), alpha fetoprotein (AFP) and squamous cell (SC) levels. RESULTS The AFP, K + and WBC levels of sample III and sample IV were significantly lower than sample I in group 1 and group 2 (P < 0.05). Significantly more SCs were found in sample III than in sample I in group 1 and group 2 (P < 0.05), but SCs of sample IV had no statistical difference compared to sample I in group 1 and group 2 (P > 0.05). There was no significant difference in the K + , Hb, WBC, AFP and SC levels of sample IV between group 1 and group 2 (P > 0.05). The HbF levels of sample III and sample IV were significantly higher in group 1 than in group 2 (P < 0.05). CONCLUSION There is little or no possibility for AF contamination to enter the re-infusion system when used in conjunction with a leucodepletion filter. For maternal with Rh-negative blood, we recommend two suction devices to reduce HbF pollution. TRIAL REGISTRATION ChiCTR1800015684 , 2018.4.15.
Tranexamic Acid for Prevention of Hemorrhage in Elective Repeat Cesarean Delivery - A Randomized Study
American journal of obstetrics & gynecology MFM. 2022;:100573
BACKGROUND The American College of Obstetricians and Gynecologists states that data is insufficient to recommend Tranexamic acid (TXA) prophylaxis for postpartum hemorrhage. OBJECTIVE This study's objective was to evaluate if prophylactic TXA reduces calculated blood loss versus placebo in women undergoing elective repeat cesarean delivery. STUDY DESIGN A double-blind, randomized, placebo-controlled trial, examining calculated blood loss with prophylactic doses of 1-gram of TXA given before skin incision and after placental delivery and standard uterotonics in women with singleton pregnancies at least 37 weeks' gestation, presenting for their second or third cesarean delivery under neuraxial anesthesia. The primary outcome was calculated blood loss at 24 hours. The calculation was based on the participant's height, weight, and the difference in hematocrit before the start of surgery and 24 hours after delivery. Prespecified secondary outcomes were quantification of maternal coagulation activity during the perioperative course. A sample size of 50 women per group was planned (N=100), based on a meta-analysis of mean reduction in blood loss after TXA. RESULTS 723 women were screened, and 110 women were randomized as follows: 55 to TXA and 55 to placebo. The primary outcome of mean calculated blood for TXA (2274 ± 469 mL) and the placebo group (2407 ± 388 mL), p > 0.05. In the secondary outcomes, D-dimer levels were lower in the TXA group than the placebo group 24 hours after delivery (2.1 ± 1.2 µg/mL versus 4.3 ± 2.4 µg/mL), p < 0.001. CONCLUSIONS Prophylactic tranexamic acid did not decrease mean calculated blood loss. Significantly less participants had calculated blood loss greater than 2000 mL in the tranexamic acid group compared to the placebo group with lower levels of D-dimer at 24 hours.
Women undergoing elective repeat caesarean delivery (n= 110).
Prophylactic doses of tranexamic acid (TXA) before skin incision and after placental delivery (n= 55).
Standard uterotonics (n= 55).
The mean calculated blood loss for TXA was 2,274 ± 469 mL, and for standard uterotonics was 2407 ± 388 mL. D-dimer levels were lower in the TXA group than the placebo group 24 hours after delivery (2.1 ± 1.2 µg/mL vs. 4.3 ± 2.4 µg/mL).
Perioperative prophylactic internal iliac artery balloon occlusion for prevention of postpartum haemorrhage in placenta praevia: a randomised controlled trial (abridged secondary publication)
Hong Kong medical journal = Xianggang yi xue za zhi. 2022;28 Suppl 1(1):23-26
Epidural anaesthesia and myomectomy-associated blood loss: - a prospective randomised controlled study
Ginekologia polska. 2022
OBJECTIVES The management of anaesthesia for patients with large myomas is particularly important due to disruption of hemodynamic as a result of massive haemorrhage, the prolonged duration of surgery and requirement for additional interventions. This study evaluated the effect of anaesthetic technique on blood loss in patients undergoing myomectomy due to large fibroid uterus. MATERIAL AND METHODS A total of 156 patients that underwent myomectomy were randomized into two equal groups according to the type of anaesthesia: Epidural anaesthesia group and General anaesthesia group. The volume of blood loss and blood products transfusion was reviewed for each patient. RESULTS The intraoperative blood loss and need for blood transfusion were significantly higher in general anaesthesia group (p < 0.001). The mean hematocrit change was 2.5 ± 1.5 vs 3.7 ± 2.9 % (p = 0.001) for both groups. CONCLUSIONS In the myomectomy planning of women with a large fibroid uterus, the team of gynecologists and anaesthesiologists should take care to choose the most optimal technique for anaesthesia.
Impact of "natural" cesarean delivery on peripartum blood loss: A randomized controlled trial
American journal of obstetrics & gynecology MFM. 2022;:100642
BACKGROUND Early skin to skin contact after vaginal delivery increases milk production and may increase oxytocin release, leading to reduction in postpartum hemorrhage (PPH) rate. OBJECTIVE To examine the impact of "natural" cesarean deliveries (NCD) on perioperative maternal blood loss. STUDY DESIGN This is a randomized controlled trial conducted at a single university affiliated medical center, between August 2016 and February 2018. Term singleton gestations scheduled for a planned CD under spinal anesthesia were included. Women were randomized at a ratio of 1:1 to NCD (study group) or traditional CD (control group) during the routine preoperative assessment. Women in the study group watched fetal extraction, had early skin to skin contact, and breastfed until the end of surgery. Neonates in the control group were presented to the mother for few minutes. Blood samples were drawn from all women, during fascia closure, to determine oxytocin levels using an ELISA kit. The Laboratory component was performed after recruitment completion and was accomplished in February 2019. The primary outcome was postpartum hemoglobin (Hb) levels. To detect a difference of 0.5 g/dL between the groups with α = .05 and β = 80%, 214 women were needed. RESULTS Of 214 women that were randomized, 23 were excluded. There were no significant differences in demographic and obstetric variables between the groups. Postpartum Hb levels were 10.1±1.1 and 10.3±1.3 g/dL in the study and control groups, respectively (P = .19). There were no significant differences in rates of PPH and blood transfusion. Maternal pain scores, satisfaction, and exclusive breastfeeding, were comparable. Maternal oxytocin blood levels were 389.5±183.7 and 408.5±233.6 pg/mL in the study and control groups, respectively (P = .96). Incidence of neonatal hypothermia was comparable between the groups (P=.13). CONCLUSIONS NCD does not affect perioperative Hb level or maternal oxytocin blood concentration. CLINICAL TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02768142.
Safety and efficacy of lidocaine plus epinephrine on intraoperative bleeding in abdominal myomectomy: A double-blind clinical trial
Health science reports. 2022;5(2):e551
BACKGROUND Uterine fibroid is a common benign pelvic tumor and abdominal myomectomy may cause excessive intraoperative bleeding, which may lead to adverse outcomes. OBJECTIVE This study was planned to evaluate the effectiveness of the injection of lidocaine plus epinephrine to reduce intraoperative bleeding in abdominal myomectomy. METHODS During October 2019 and May 2020, 60 eligible women with uterine fibroids were enrolled in a randomized controlled trial. Our patients were divided into two groups of lidocaine plus epinephrine defined as Group L and placebo defined as Group P. In group L, lidocaine 3 mg/kg plus 0.5 ml of adrenaline which reached to 50 cc with saline solution and in group P, 50 ml of normal saline was used. Both the combined solution and normal saline were infiltrated to the serous and myometrium above and around the fibroid before incision. Patients' demographic data, total operative time, hemoglobin changes, and the degree of surgical difficulty were evaluated and compared between the two groups. RESULTS There was no significant difference between the two groups in terms of demographic data. Hemoglobin changes (p < 0.0001) and the degree of surgery difficulty (p = 0.01) were significantly lower in Group L compared with Group P. In each group the drop in hemoglobin levels from baseline to 4 h postoperatively was significant (p < 0.0001). A significantly meaningful correlation was reported between hemoglobin changes and the degree of surgery difficulty with the size of the uterine and fibroids (p < 0.05). While a negative correlation was found regarding gravidity and surgery difficulty (r = -0.413, p = 0.02). Surgery duration was longer in Group P compared with Group L 70.66 ± 19.85 versus 66.16 ± 14.48, respectively, but with no significant difference (p = 0.32). No significant adverse reaction or serious complication was reported in the two groups. Hemodynamic parameters were kept in the normal range throughout the surgery. CONCLUSION A combination of lidocaine plus epinephrine during abdominal myomectomy appears to be a safe and effective method in reducing blood loss.
The Efficiency of Temporary Uterine Artery Ligation on Prevention of the Bleeding in Cesarean Section
Gynecologic and obstetric investigation. 2021;:1-8
OBJECTIVE We aimed to evaluate the effect of temporary ligation of the uterine artery on postpartum bleeding during uncomplicated cesarean section. DESIGN This was a prospective, randomized, and controlled study. We recruited a total of 200 patients, including 100 cases and 100 controls. METHODS The bilateral uterine artery was temporarily clamped 2 cm below the uterine incision in the study group and compared with controls. Patient demographics, the amount of intraoperative bleeding, the duration of the operation, the closure time of the uterine incision, the need for additional uterotonics, the need for additional sutures, and the hemoglobin values before and after birth were assessed. RESULTS The mean value of the amount of bleeding in the clamped and control groups was 267.3 ± 131.8 mL and 390.2 ± 116.4 mL, respectively. The amount of bleeding was significantly decreased for clamped group (p < 0.001). A significant reduction occurred in the results of pre- and postoperative values of hemoglobin and hematocrit difference, operation duration, and the closing time of the uterine incision in the experimental group which has temporary uterine artery clamping. LIMITATIONS The cases of recurrent cesareans were not included in this study. CONCLUSION Temporary uterine artery ligation can be used to reduce the amount of bleeding during uncomplicated cesarean delivery and prevent postpartum hemorrhage.
Comparison of intra operative hemorrhage by blunt and sharp expansion of uterine incision at cesarean section
Pakistan journal of medical sciences. 2021;37(7):1994-1998
OBJECTIVES To compare the effect of blunt and sharp incision of uterus at cesarean section on intra-operative haemorrhage. METHODS This trial was conducted at the Department of Obstetrics and Gynaecology, Pakistan Ordinance Factory Hospital, Wah Cantt from 14(th) January to 13(th) July 2012. Total 80 women planned for lower segment cesarean section through Pfannensteil incision were randomized to either blunt uterine incision (Group-A, n=40) or sharp uterine incision (Group-B, n=40). The fall in Haemoglobin and HCT was compared in two groups and analyzed with help of SPSS version 10. RESULTS Both groups were similar in terms of demographic features like age, parity, gestational age and indication for cesarean section. The participants in Group-A reveled significantly less drop of mean Hb concentration as compared to Group-B (1.47±1.08 and 1.95±0.85 respectively, P value 0.031). Similarly, the fall in mean HCT was significantly less in Group-A in comparison to Group-B (3.21±1.3 and 4.21±2.17 respectively, P-value 0.015). CONCLUSION Blunt expansion of uterine incision during caesarean section is associated with less fall in Haemoglobin and HCT as compared to sharp expansion.