Effectiveness of preoperative tranexamic acid in reducing blood loss during caesarean section at Aminu Kano Teaching Hospital, Kano: a randomized controlled trial
The Pan African medical journal. 2021;39:34
INTRODUCTION bleeding during and after caesarean section is one of the contributors to maternal mortality and morbidity. Tranexamic acid can be given before surgery to significantly reduce the amount of blood loss during caesarean section. The objective was to evaluate the effectiveness of preoperative tranexamic acid in reducing blood loss during caesarean section at Aminu Kano Teaching Hospital, Kano. METHODS this was a randomized double blind placebo controlled study that was carried out among 244 women who were to have emergency caesarean section between December 2017 and June 2018 and were randomly assigned to the study group or control group. Women in the study group received lg (10mls) of tranexamic acid intravenously while women in the control group received 10ml of normal saline. Oxytocin was administered in the two groups according to protocol. Measurement of blood loss was done immediately after surgery. Postoperative drop in haemoglobin and haematocrit were also determined. Statistical analysis was done using SPSS Version 22. RESULTS the average intra operative blood loss was 414.0 ml in the study group and 773.8 ml in the control group (t = - 16.18, p ≤ 0.01). Average postoperative haemoglobin was 10.1 g/dl in the study group and 9.5 g/dl in the control group (t = 4.99, p ≤ 0.01). Average postoperative haematocrit was 31.5% in the study group and 29.9% in the control group (t = 4.70, p ≤ 0.01). CONCLUSION there was a significant reduction in the blood loss when preoperative tranexamic acid was given to patients who were to undergo emergency caesarean section.
Women having emergency caesarean section in a single centre in Nigeria (n= 244).
Intravenous tranexamic acid (n= 122).
Normal saline (n= 122).
There was a significant reduction in blood loss when preoperative tranexamic acid compared to the normal saline. The average intra operative blood loss was 414.0 ml in the study group and 773.8 ml in the control group. Average postoperative haemoglobin was 10.1 g/dl in the study group and 9.5 g/dl in the control group. Average postoperative haematocrit was 31.5% in the study group and 29.9% in the control group.
Effects of colloid preload on the incidence of hypotension in spinal anesthesia for cesarean section: a systematic review and meta-analysis
Chinese medical journal. 2021
BACKGROUND Hypotension is a common complication caused by spinal anesthesia (SA), which may have adverse impacts on the condition of the parturient and fetus. Liquid infusion was found to be relatively effective for reducing the incidence of hypotension. However, the question of whether colloid preload can optimize hemodynamic variables in the cesarean section remains controversial. This study aims to determine the effects of colloid preload on the incidence of hypotension induced by SA in elective cesarean section. METHODS Related keywords were searched on PubMed, EMBASE, and Cochrane Library from inception dates to May 2020. Studies included were evaluated for eligibility and quality. The primary outcome was the intra-operative incidence of hypotension and severe hypotension. The secondary outcomes included the lowest intra-operative systolic blood pressure, the maximal intra-operative heart rate, the intra-operative needs of ephedrine and phenylephrine, the incidence of maternal nausea and/or vomiting, and neonatal outcomes (umbilical artery pH and Apgar scores). Apart from the above, RevMan 5.3 was used for the data analysis. RESULTS Altogether nine randomized controlled trials were included in the meta-analysis. There were no significant differences in the incidence of intra-operative hypotension, severe hypotension, or neonatal outcomes between the colloid preload group and control group, except for the umbilical artery pH. CONCLUSION This meta-analysis suggests that colloid preload does not significantly reduce the incidence of hypotension associated with SA in elective cesarean section.
Ovarian function following use of various hemostatic techniques during treatment for an endometrioma: A randomized controlled trial
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2021
OBJECTIVE To compare the effect of hemostatic techniques (bipolar energy versus hemostatic sealants versus suture) on the ovarian reserve of patients submitted to laparoscopic cystectomy for the surgical excision of a unilateral endometrioma. METHODS A randomized controlled trial conducted in a teaching hospital included 84 patients with a unilateral endometrioma. The patients underwent laparoscopic stripping for excision of the unilateral endometrioma between March 2018 and February 2020. Three different hemostatic techniques - bipolar energy (Group 1), hemostatic sealants (Group 2) and suture (Group 3) - were compared. Anti-Müllerian hormone (AMH) levels were measured prior to and 1 and 6 months after surgery to determine changes in ovarian function. RESULTS Following surgery, AMH levels decreased in all the groups; however, this decrease was not statistically significant. Comparison between groups showed no statistically significant differences in AMH levels between the three hemostatic techniques used. Six months after surgery, median AMH levels were: 1.65 (interquartile range [IQR]: 0.62-2.08) ng/ml in Group 1, 1.87 (IQR: 1.27-2.97) in Group 2, and 1.53 (IQR: 1.18-2.44) in Group 3. CONCLUSION The present study suggests that there is no difference between the different hemostatic techniques used in laparoscopic cystectomy for the treatment of unilateral endometriomas.
Effects of intravenous tranexamic acid on ovarian reserve and intra-operative blood loss during laparoscopic cystectomy of endometriotic cyst: a pilot randomized controlled trial
Pilot and feasibility studies. 2021;7(1):171
BACKGROUND Strategies to preserve ovarian function after ovarian endometriotic cyst removal have been reported in many studies; however, no study has evaluated tranexamic acid administration during surgery. OBJECTIVE To evaluate feasibility of conducting a definitive trial and assessing the potential efficacy of tranexamic acid on ovarian reserve and intra-operative blood loss by comparing mean differences in anti-Müllerian hormone (AMH) levels following laparoscopic ovarian cystectomy between tranexamic acid and control groups. MATERIALS AND METHODS A parallel two-arm pilot trial was conducted with 40 participants with endometriotic cysts who underwent laparoscopic ovarian cystectomy. They were randomized 1:1 to either 1 g tranexamic acid (TXA) or no TXA (n = 20 per group). TXA was administered to the participants immediately after induction of general anesthesia and intubation. The primary outcome was the feasibility of conducting a definitive trial in terms of design and procedures (such as recruitment rate, retention, safety of intravenous 1 gm of TXA, sample size verification) and assess the efficacy of TXA on the ovarian reserve and intra-operative blood loss by comparing mean difference of AMH levels between TXA and control groups at pre- and 3 months post-surgery. RESULTS The recruitment and successful completion rates were 95% and 100%. Baseline characteristics were similar in the two groups. The mean difference of serum AMH levels (pre- and 3 months post-surgery) between the TXA and control groups was not significantly different. When performing a subgroup analysis, the mean difference of AMH levels (pre- and 3 months post-surgery) seemed to be higher in the bilateral than in the unilateral ovarian cyst group but not significantly different. Operating time was significantly longer in bilateral than in unilateral cysts. No post-operative complications or adverse effects were found. CONCLUSION The full randomized controlled trial for evaluating effects of TXA administration during laparoscopic cystectomy for endometrioma on ovarian reserve was shown to be feasible. Several modifications should be added for improving feasibility, for example, increasing the TXA dose, modifying TXA administration, focusing on either patients with unilateral or bilateral ovarian cysts, and exploring other outcome measures, e.g., surgeons' satisfaction. TRIAL REGISTRATION Thai Clinical Trials Registry, TCTR20190424002 , Registered 24 April 2019.
Comparison of Bipolar Ball Endometrial Ablation and Transcervical Resection of the Endometrium in the Treatment of Heavy Menstrual Bleeding: A Randomized Clinical Trial
Gynecology and minimally invasive therapy. 2021;10(3):143-147
OBJECTIVES To compare the operative time, effectiveness, and patient satisfaction between ball endometrial ablation and transcervical resection of the endometrium (TCRE) using a bipolar resectoscope. MATERIALS AND METHODS Forty-four women with heavy menstrual bleeding who were unresponsive to at least 3 months' medical management were included in this randomized, controlled clinical trial. After randomization, patients underwent either TCRE or ball endometrial ablation using a bipolar resectoscope. The operative time, fluid deficit, and postoperative pain were recorded. The patients were evaluated postoperatively at 3, 6, and 12 months after surgery. Patient satisfaction, amenorrhea rate, reintervention rate, and pictorial blood-loss-assessment chart (PBAC) score were compared between the two groups. RESULTS The mean operative time in ball endometrial ablation group was 11.17 ± 2.24 min and in TCRE group was 22.33 ± 5.26 min (P < 0.001). There was no significant difference in the postoperative PBAC score, amenorrhea rates, patient satisfaction, and need for reintervention between the two groups. CONCLUSION Operative time with ball endometrial ablation is significantly less when compared to TCRE when using a bipolar resectoscope.
Intravenous oxytocin dosing regimens for postpartum hemorrhage prevention at cesarean section: a systematic review and meta-analysis
American journal of obstetrics and gynecology. 2021
OBJECTIVE To synthesize available evidence on intravenous (IV) oxytocin dosing regimens for the prevention of postpartum hemorrhage (PPH) at cesarean section (CS). DATA SOURCES We searched Medline/OVID, Embase, Global Index Medicus, CINAHL, CENTRAL, ClinicalTrials.gov, and ICTRP for eligible studies published until Feb 2020. STUDY ELIGIBILITY CRITERIA We included any randomized or non-randomized study published in peer-reviewed journals that compared at least two different dosing regimens of IV oxytocin for PPH prevention in women undergoing CS. STUDY APPRAISAL AND SYNTHESIS METHODS Two authors independently assessed eligibility, extracted data, and assessed risk of bias. Primary outcome was incidence of PPH ≥ 1000 mL. Other review outcomes included use of additional uterotonics, blood loss, and adverse maternal events. Data were analyzed based on type of IV administration (bolus only, infusion only, bolus plus infusion) and oxytocin dose. Meta-analysis was performed using randomized trials and reported using risk ratios or mean difference with 95% confidence intervals. GRADE was used to rate the certainty of evidence. Findings from dose-finding trials and non-randomized studies were reported narratively. RESULTS Thirty-five studies (7,333 women) met our inclusion criteria, including 30 randomized trials and five non-randomized studies. There were limited data from trials for most outcomes, and results were not conclusive. Compared to bolus plus infusion regimens, bolus only regimens probably result in slightly higher mean blood loss (MD 52 mL, 95% CI 0.4-104 mL, moderate certainty). Amongst bolus plus infusion regimens, initial bolus doses < 5 IU may reduce nausea (RR 0.26, 95% CI 0.11-0.63, low certainty) as compared to 5-9 IU. Total oxytocin doses 5-9 IU versus 10-19 IU may increase use of additional uterotonics (RR 13.00, 95% CI 1.75-96.37, low certainty). Effects on other outcomes were generally inconclusive. CONCLUSION There are limited data comparing IV oxytocin regimens for PPH prevention at CS. Bolus plus infusion regimens may lead to minor reductions in mean blood loss, and initial bolus doses of < 5 IU may minimize nausea. Bolus only regimens of 10 IU versus 5 IU may decrease use of additional uterotonics, however further comparative trials are required to understand effects on other key outcomes, particularly hypotension.
A Systematic Review of Minimally Invasive Treatments for Uterine Fibroid-Related Bleeding
Reproductive sciences (Thousand Oaks, Calif.). 2021
Newer minimally invasive techniques provide treatment options for symptomatic uterine fibroids while allowing uterus preservation. The objective of this review was to analyze the efficacy of uterine-preserving, minimally invasive treatment modalities in reducing fibroid-related bleeding. A comprehensive search was conducted of PubMed, Embase, PsycINFO, ClinicalTrials.gov, Scopus, and Cochrane Library databases from inception to July 2020. English-language publications that evaluated premenopausal women with fibroid-related bleeding symptoms before and after treatment were considered. Randomized controlled trials were assessed for bias with the established Cochrane Risk of Bias Tool 2.0 and observational studies were assessed for quality under the New Castle-Ottawa Scale guidelines. Eighty-four studies were included in the review, including 10 randomized controlled trials and 74 observational studies. Six studies on myomectomy demonstrated overall bleeding symptom improvement in up to 95.9% of patients, though there was no significant difference between mode of myomectomy. Forty-one studies on uterine artery embolization reported significant reduction of fibroid-related bleeding, with symptomatic improvement in 79 to 98.5% of patients. Three studies suggested that embolization may be superior to myomectomy in reducing fibroid-related bleeding. Six studies reported that laparoscopic uterine artery occlusion combined with myomectomy led to greater reduction of bleeding than myomectomy alone. Fifteen studies demonstrated significantly reduced bleeding severity after radiofrequency ablation (RFA). Additional research is needed to establish the superiority of these modalities over one another. Long-term evidence is limited in current literature for magnetic resonance-guided focused ultrasound surgery, cryomyolysis, microwave ablation, and laser ablation.
Ovarian reserve and recurrence 1 year post-operatively after using haemostatic sealant and bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy
Reproductive biomedicine online. 2021
RESEARCH QUESTION Is there a difference in the ovarian reserve 1 year post-operatively in those who used a haemostatic sealant or bipolar diathermy for haemostasis during laparoscopic ovarian cystectomy for ovarian endometriomas? DESIGN This was an extended follow-up observational study of a previous randomized controlled trial where women aged 18 to 40 years with 3-8 cm unilateral or bilateral endometriomas were randomized to receive haemostasis by a haemostatic sealant or bipolar diathermy following ovarian cystectomy. The primary outcome was the ovarian reserve as assessed by antral follicle count (AFC) 1 year post-operatively. Secondary outcomes included the recurrence rate of ovarian endometrioma, the change in anti-Müllerian hormone (AMH) and FSH concentrations, and reproductive outcomes. RESULTS The significant increase in AFC at 3 months after initial surgery (P = 0.025) in the haemostatic sealant group compared with the diathermy group was sustained at 1 year (P = 0.024) but there was no difference in AMH or FSH concentrations between the groups throughout the follow-up period. The recurrence rate in the FloSeal group was 7.7% (n = 3/39) compared with 22.2% (n = 8/36) in the diathermy group (P = 0.060). The recurrence rate in women who had bilateral lesions was significantly higher than those with unilateral lesions (risk ratio 5.33, interquartile range 1.55-18.38). No difference in reproductive outcomes was found between the two groups. CONCLUSIONS Applying haemostatic sealant after laparoscopic cystectomy of ovarian endometriomas produces a significantly greater improvement in AFC, which was apparent at 3-month follow-up, and was sustained at 1-year follow-up without compromising the recurrence rate.
Timing of oxytocin administration to prevent post-partum hemorrhage in women delivered by cesarean section: A systematic review and metanalysis
PloS one. 2021;16(6):e0252491
BACKGROUND There is no consensus on the best timing for prophylactic oxytocin administration during cesarean section (CS) to prevent post-partum hemorrhage (PPH). OBJECTIVES Assess the effects of administrating prophylactic oxytocin at different times during CS. METHODS We searched nine databases to identify relevant randomized controlled trials (RCT). We pooled results and calculated average risk ratios (RR), mean differences (MD), and 95% confidence intervals (CI). We used GRADE to assess the overall evidence certainty. RESULTS We screened 13,389 references and included four trials. We found no statistically significant differences between oxytocin given before versus after fetal delivery on PPH (RR 0.60, 95%CI 0.15-2.47; 1 RCT, N = 300) or nausea/vomiting (RR 1.21, 95%CI 0.69-2.13; 1 RCT, N = 300). There was a significant reduction in the need for additional uterotonics when oxytocin was given immediately before uterine incision versus after fetal delivery (RR 0.37, 95%CI 0.18-0.73; I2 = 0%; 2 RCTs; N = 301). Oxytocin given before fetal delivery significantly reduced intra-operative blood loss (MD -146.77mL, 95%CI -168.10 to -125.43; I2 = 0%; 3 RCTs, N = 601) but did not change the incidence of blood transfusion (RR 0.50, 95%CI 0.13-1.95; I2 = 0%; 2 RCTs, N = 301) or hysterectomy (RR 3.00; 95%CI 0.12-72.77; I2 = 0%; 2 RCTs, N = 301). One trial (N = 100) compared prophylactic oxytocin before versus after placental separation and found no significant differences on PPH, additional uterotonics, or nausea/vomiting. CONCLUSIONS In women having pre-labor CS, there is limited evidence indicating no significant differences between prophylactic oxytocin given before versus after fetal delivery on PPH, nausea/vomiting, blood transfusion, or hysterectomy. Earlier oxytocin administration may reduce the volume of blood loss and need for additional uterotonics. There is very limited evidence suggesting no significant differences between prophylactic oxytocin given before versus after placental separation on PPH, need for additional uterotonic, or nausea/vomiting. The overall certainty of the evidence was mostly low or very low due to imprecision. Protocol: CRD42020186797.
A randomized controlled trial of ovarian reserve preservation and hemostasis during ovarian cystectomy
Scientific reports. 2021;11(1):8495
The preservation of ovarian reserve during laparoendoscopic single-site (LESS) ovarian cystectomy is crucial for reproductive-age women. This study was a single-blinded, single-center, and randomized controlled trial to evaluate the effect of hemostatic agents on the preservation of ovarian reserve and hemostasis during LESS ovarian cystectomy. Patients with unilateral ovarian cyst were randomized to the hemostatic agent and coagulation groups according to the hemostasis method. Afterwards, the patients underwent LESS ovarian cystectomy, and hemostasis was performed after ovarian cyst excision according to the assigned hemostasis method. If hemostasis was not completed within 10 min. After discharge, the patients were followed until 3 months after surgery. We compared the hemoglobin, anti-Müllerian hormone (AMH) levels, and ovarian volumes before surgery, and 2 days, 1 week, and 3 months after surgery (3 M-POST), and the decline ratio between the two groups. The decline ratio of serum AMH levels was greater at 3 M-POST in the coagulation than in the hemostatic agent group (median intention-to-treat [ITT], - 36.7 vs. - 13.3%; per-protocol [PP], - 36.8 vs. - 13.3%; P < 0.05). Notably, the difference of the decline ratio of serum AMH levels was only shown in endometriosis patients (median; ITT, - 50.7 vs. - 14.4%; PP, - 50.7% vs. - 14.4%; P < 0.05), while there was no difference in non-endometriosis patients. In conclusion, Hemostatic agents may be non-inferior to bipolar coagulation for preserving ovarian reserve and hemostasis during LESS ovarian cystectomy, in particular, for endometriosis patients. (Trial registry: ClinicalTrials.gov Identifier NCT03374397).