Intramyometrial and intravenous oxytocin compared to intravenous carbetocin for prevention of postpartum hemorrhage in elective cesarean section-A quasi-randomized controlled phase IV non-inferiority interventional trial.

INTRODUCTION: Our objective was to assess non-inferiority of the unique approach used in our institution of combined 10 IU IM (intramyometrial) and 10 IU IV (intravenous) oxytocin to carbetocin IV in preventing severe postpartum blood loss in elective cesarean sections. The design was a prospective controlled phase IV non-inferiority interventional trial. The setting was a tertiary center at University Hospital, Zurich, Switzerland. MATERIAL AND METHODS: The population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH). Participants were assigned to either combined oxytocin regimen (10 IU IM and 10 IU IV) or carbetocin (100 µg IV). Non-inferiority for oxytocin for severe PPH was assessed with a 0.05 margin using the Newcombe-Wilson score method. The main outcome measures were severe postpartum blood loss defined as delta hemoglobin (∆Hb, Hb prepartum-Hb postpartum) ≥30 g/L. RESULTS: Non-inferiority of combined oxytocin (IM/IV) in preventing severe postpartum blood loss was not shown (17 women in the oxytocin group vs. 7 in the carbetocin group). The number needed to treat when using carbetocin was 28. The risk difference for ∆Hb ≥30 g/L was 0.04 (oxytocin 0.06 vs. 0.03), 95% confidence interval (CI) (0.00-0.08). No significant difference was observed for ∆Hb (median 12 [IQR 7.0-19.0] vs. 11 [5.0-17.0], p = 0.07), estimated blood loss (median 500 [IQR 400-600] vs. 500 [400-575], p = 0.38), or the PPH rate defined as estimated blood loss ≥1000 mL (12[4.5] vs. 5 [2.0], risk difference 0.03, 95% CI (-0.01 to 0.06), p = 0.16). More additional uterotonics were administered in the oxytocin group compared to the carbetocin group (15.2% vs. 5.9%, p = 0.001). Total case costs were non-significantly different in the oxytocin group (US $ 10 146 vs. 9621, mean difference 471.4, CI (-476.5 to 1419.3), p = 0.33). CONCLUSIONS: Combined (IM/IV) oxytocin is not non-inferior to carbetocin regarding severe postpartum blood loss defined as postpartum Hb decrease ≥30 g/L in elective cesarean sections. We recommend carbetocin for use in clinical practice for elective cesarean sections.

[Can we predict intrauterine balloon tamponade failure according to the mode of delivery?] / Peut-on prévenir l'échec du ballon de tamponnement intra-utérin selon la voie d'accouchement ?

OBJECTIVE: The intrauterine balloon tamponade (IUBT) is one of the major tool to manage the postpartum hemorrhage (PPH). Previous studies identified factors predicting IUBT failure regardless the mode of delivery. Our aim was to determine if IUBT predictive failure can be determined regarding the mode of delivery. MATERIALS AND METHODS: This was a retrospective cohort study among women who had IUBT secondary to severe PPH after vaginal or cesarean delivery from 2012 until 2021 at Lille (France). We compared 2 groups: success or failure of the IUBT, which was defined as the need of additional invasive procedures (uterine embolization or surgical procedure). RESULTS: We included 238 women, 83 who underwent cesarean and 155 vaginal delivery. The overall success of the IUBT was 78% (80% for vaginal delivery and 75% for cesarean delivery). In the vaginal delivery group with failed IUBT, coagulopathies were significantly more frequent (84.2 vs. 33.3% P=<0.001) with higher estimated blood loss at the use of the IUBT (1865.8 vs. 1580.8mL, P=0.015) compared with the vaginal delivery group with success of IUBT. In the cesarean delivery group, none factor was significant between the two groups. CONCLUSION: It is possible to identify predictors of IUBT failure in case of vaginal delivery. In contrast, in case of cesarean delivery, there is no apparent predictive facto. It could be interesting to validate our findings in a multicentric study.

Phytochemical constituents from the roots and lignotubers of Rhoicissus tridentata and their in vitro uterotonic activity.

Rhoicissus tridentata is one of the most frequently used plants in preparing Isihlambezo, a herbal drink consumed by many South African women to induce labour and tone the uterus in pregnancy. This study aimed to identify the uteroactive compounds in this plant. Chromatographic purification of the methanol and water extracts from the roots yielded eight compounds, i.e. morin 3-O-α-L-rhamnopyranoside, trans-resveratrol 3-O-ß-glucopyranoside, a mixture of asiatic and arjunolic acids, quercetin 3-O-rhamnopyranoside, catechin, ß-sitosterol, and linoleic acid. All compounds were evaluated for their uterotonic effects using uterine smooth muscle isolated from stilboestrol-primed Sprague-Dawley rats. The mixture of asiatic and arjunolic acids showed the highest activity with EC50 of 0.02129 µg/mL for amplitude. These results validate the use of R. tridentata in ethnomedicine to facilitate labour in childbirth. Morin 3-O-α-L-rhamnopyranoside and trans-resveratrol 3-O-ß-glucopyranoside caused a relaxation of the uterine muscle, which suggests that some compounds in R. tridentata possess opposing activities.

A survey evaluating practice pattern in management of obstetric hemorrhage.

BACKGROUND: Hemorrhage anticipation and management has shifted significantly over the past decade due to evolution of data surrounding management of obstetric hemorrhage. Limited data exists which describe the practical use and clinical application of hemorrhage management. Our goal was to identify obstetric hemorrhage management patterns in a cohort of practicing Maternal Fetal Medicine physicians. METHODS: We administered a survey to Maternal Fetal Medicine (MFM) fellows and faculty that addressed the management of hemorrhage including risk assessment, uterotonic use, antifibrinolytic use, cell saver use, and abnormal placentation management. An email was sent out regarding the survey to a listserv of all Maternal Fetal Medicine fellow program coordinators to disseminate to their faculty and fellows. Eighty responses were obtained. RESULTS: A total of 78 surveys were analyzed. Participants preferred methylergonovine as a first line agent (n = 57; 73%, n = 62; 80%). Most participants would consider using cell salvage when also activating MTP (28, 48%) or during scheduled deliveries who are high risk of hemorrhage (40, 69%). Approximately a third of providers would use TXA (tranexamic acid) prophylactically (n = 21; 28%). Only 26% of MFM fellows felt comfortable performing cesarean hysterectomy without Gynecologic Oncology. CONCLUSION: In comparison to prior reports, TXA use has increased substantially. Further, when looking at the management of abnormal placentation, the use of magnetic resonance imaging and embolization have both increased. Possibly due to the rise in centers of excellence for treatment of accreta spectrum disorders, Maternal Fetal Medicine fellows still feel largely unprepared to perform a cesarean hysterectomy without Gynecologic Oncology.

The efficacy of three regimes of uterotonic agents for prevention of postpartum blood loss at undergoing cesarean section: a prospective randomized clinical trial.

OBJECTIVES: To compare the efficacy of three regimes of uterotonic agents on PPH in women undergoing cesarean section in our RCT. MATERIAL AND METHODS: This study was a randomized controlled study (NCT05083910) performed at the Bezmialem Vakif University between July 2021 and January 2022. All women were randomly allocated into three groups: Group I (n = 52) - oxytocin only; Group II (n = 52) - the combination of oxytocin plus intrauterine misoprostol; Group III (n = 52) - carbetocin only. The primary outcome measures were: PPH to evaluate with the change between the concentrations of preoperative and postoperative hemoglobin, hematocrit and intraoperative blood loss. RESULTS: The blood loss characteristics, including the change in hemoglobin and the change in hematocrit concentration, intraoperative blood loss, intraoperative additional hemostatic uterine sutures and the need for additional uterotonics, were lowest in group III, although all groups were comparable in terms of blood loss parameters. Group III had the highest blood loss ratio, exceeding 1000 mL. For the combination of oxytocin and intrauterine misoprostol, the ARR was 3.8% (95% CI 20.02-12.33), with a RR of 1.18 (95% CI 0.58-2.39) and a NNT of 26 (95% CI 8.1-4.9); for carbetocin, the ARR was 5.8% (95% CI 22.15-10.61), with a RR of 1.27 (95% CI 0.63-2.53) and a NNT of 17 (95% CI 9.41-4.51). CONCLUSIONS: Our results demonstrate that carbetocin shows no superiority in the prevention of PPH in women undergoing cesarean section. Oxytocin still seems to be a highly effective alternative to prevent PPH.

Effect of an oxytocin protocol on secondary uterotonic use in patients undergoing Cesarean delivery.

PURPOSE: Protocol-driven oxytocin regimens can reduce oxytocin administration compared with a nonprotocol free-flow continuous infusion. Our aim was to compare secondary uterotonic use between a modified "rule of threes" oxytocin protocol and a free-flow continuous oxytocin infusion after Cesarean delivery. METHODS: We conducted a retrospective before-and-after study to compare patients who underwent Cesarean delivery between 1 January 2010 and 31 December 2013 (preprotocol) with patients who underwent Cesarean delivery between 1 January 2015 and 31 August 2017 (postprotocol). The preprotocol group received free-flow oxytocin administration and the postprotocol group received oxytocin according to a modified rule of threes algorithm. The primary outcome was secondary uterotonic use and the secondary outcomes included blood transfusion, hemoglobin value < 8 g·dL-1, and estimated blood loss. RESULTS: In total, 4,010 Cesarean deliveries were performed in 3,637 patients (2,262 preprotocol and 1,748 postprotocol). The odds of receiving secondary uterotonic drugs were increased in the postprotocol group (odds ratio [OR], 1.33; 95% confidence interval [CI], 1.04 to 1.70; P = 0.02). Patients in the postprotocol group were less likely to receive a blood transfusion. Nevertheless, the two groups were similar for the composite end point of transfusion or hemoglobin < 8 g·dL-1 (OR, 0.86; 95% CI, 0.66 to 1.11; P = 0.25). The odds of an estimated blood loss greater than 1,000 mL were reduced in the postprotocol group (OR, 0.64; 95% CI, 0.50 to 0.84; P = 0.001). CONCLUSIONS: Patients in the modified rule of threes oxytocin protocol group were more likely to receive a secondary uterotonic than those in the preprotocol group. Estimated blood loss and transfusion outcomes were similar.

RéSUMé: OBJECTIF: Les schémas thérapeutiques d'ocytocine basés sur un protocole peuvent réduire l'administration d'ocytocine par rapport à une perfusion continue en débit libre hors protocole. Notre objectif était de comparer l'utilisation secondaires d'agents utérotoniques entre un protocole modifié d'ocytocine en « règle de trois ¼ et une perfusion continue d'ocytocine à débit libre après un accouchement par césarienne. MéTHODE: Nous avons mené une étude rétrospective avant-après pour comparer les personnes ayant bénéficié d'une césarienne entre le 1er janvier 2010 et le 31 décembre 2013 (pré-protocole) avec les personnes ayant subi une césarienne entre le 1er janvier 2015 et le 31 août 2017 (post-protocole). Le groupe pré-protocole a reçu une administration d'ocytocine en débit libre et le groupe post-protocole a reçu de l'ocytocine selon un algorithme de règle de trois modifié. Le critère d'évaluation principal était l'utilisation secondaire d'agents utérotoniques et les critères d'évaluation secondaires incluaient la transfusion sanguine, un indice d'hémoglobine < 8 g·dL­1 et les pertes de sang estimées. RéSULTATS: Au total, 4010 accouchements par césarienne ont été réalisés chez 3637 patient·es (2262 pré-protocole et 1748 post-protocole). Les chances de recevoir des médicaments utérotoniques secondaires étaient plus élevées dans le groupe post-protocole (rapport de cotes [RC], 1,33; intervalle de confiance [IC] à 95 %, 1,04 à 1,70; P = 0,02). Les patient·es du groupe post-protocole étaient moins susceptibles de recevoir une transfusion sanguine. Néanmoins, les deux groupes étaient similaires en ce qui touchait au critère d'évaluation composite de transfusion ou d'hémoglobine < 8 g·dL­1 (RC, 0,86; IC 95, 0,66 à 1,11; P = 0,25). Les risques d'une perte de sang estimée supérieure à 1000 mL ont été réduits dans le groupe post-protocole (RC, 0,64; IC 95 %, 0,50 à 0,84; P = 0,001). CONCLUSION: Les patient·es du groupe du protocole d'ocytocine en règle de trois modifiée étaient plus susceptibles de recevoir un utérotonique secondaire que les personnes du groupe pré-protocole. Les pertes sanguines estimées et les résultats transfusionnels étaient similaires.

Trends and regional variations in prescriptions dispensed to stimulate uterine contractions at the end of pregnancy in Belgium: A community-based study from 2003 to 2018.

PURPOSE: To investigate trends and regional variations in uterotonics dispensed around birth between 2003 and 2018 in Belgium. METHODS: Data, including outpatient and inpatient prescriptions were extracted from a nationally representative prescription database. The prevalence of uterotonics dispensed during a period including the 7 days before birth, the delivery day and the 7 days after birth was computed over three 4-year-long study periods from 2003 to 2018. The trends between periods and associations between the use of at least one uterotonic and maternal age, region of residence, delivery type and social status were assessed using logistic regression. RESULTS: In total, 31 675 pregnancies were included in the study. The proportion of pregnancies exposed to at least one uterotonic decreased significantly from 92.9% (95%CI, 92.3-93.4) in 2003-2006 to 91.4% (95%CI, 90.7-92.0) in 2015-2018 for vaginal births and from 95.5% (95%CI, 94.5-96.4) to 93.7% (95%CI, 92.6-94.7) for caesarean sections. However, for vaginal births, the proportion of oxytocin increased from 84.5% (95%CI, 83.7-85.2) to 89% (95%CI 88.3-89.7). A significant association was found between uterotonic agent use and maternal age, region of residence, and delivery type. The dispensation of some uterotonic agents differed significantly between the regions. CONCLUSIONS: The proportion of pregnancies exposed to at least one uterotonic was high across the study period but decreased slightly between 2003 and 2018. Important variations in uterotonic use between regions highlight the need for improved national guidance.

Intravenous oxytocin regimens in patients undergoing cesarean delivery: a systematic review and network meta-analysis of cluster-based groups.

Information on evaluations of different oxytocin regimens used to prevent post-partum hemorrhage during cesarean delivery is scarce, and there is a lack of statistically pooled results for comparative doses. In this review, we aimed to analyze the effectiveness of different oxytocin regimens used and rank them accordingly. We performed a meta-analysis of randomized controlled trials (RCTs) reporting the incidence of additional uterotonic (AUT) use or amount of blood loss during cesarean delivery, where different oxytocin regimens were compared. Cluster analysis was used to define different clusters of oxytocin therapy based on the identified variable regimens. During the frequentist network meta-analysis, all clusters were compared to bolus clusters of dose range 3-5 IU. Data from 33 RCTs (6741 patients) to 26 RCTs (5422 patients) were assessed for AUT use and blood loss, respectively. Pairwise meta-analysis revealed a significant reduction in the use of AUTs or blood loss was recorded for bolus-infusion combination regimens. The network meta-analysis found that combined bolus-infusion regimens of (i) 3-5 IU and 0.25-1 IU/min or (ii) 3-5 IU and < 0.25 IU/min had statistically significant results for lowest consumption of AUTs (Ranks 1 and 2, respectively); whereas with the latter's use, the lowest blood loss (Rank 2) was observed. In contrast, the dose range, > 5 IU regimen was associated with higher side effects (lowest rank). During cesarean delivery, a significant reduction in the use of AUTs or blood loss (Rank 2) was recorded for bolus-infusion combination regimens. High doses did not have enough evidence to draw meaningful conclusions.

Obstetric and Maternal Outcomes After B-Lynch Compression Sutures: A Meta-Analysis.

This review article aimed to determine the obstetric and maternal outcomes after B-Lynch compression sutures to control atonic postpartum hemorrhage (PPH). This meta-analysis was performed after registering the protocol in the PROSPERO database with the registration number CRD42022355358. Two independent reviewers systematically searched electronic databases and search engines (PubMed, Cochrane Library, and Google Scholar) to retrieve published articles from inception to July 2022. The obstetric and maternal outcomes after the B-Lynch compression suture were computed using the random-effects model in pooled proportion with a 95% confidence interval (CI). Meta-regression analysis and subgroup analysis were performed to explain any source of possible heterogeneity. Quality assessment of the included studies was done using Joanna Briggs Institute (JBI) tools which are critical appraisal tools for systematic reviews and meta-analyses. This meta-analysis included a total of 30 studies involving 1,270 subjects. The pooled proportion of B-Lynch suture alone was 91% (95% CI = 82-97%). The combined proportion of B-Lynch suture plus another compression suture was 1% (95% CI = 0-3%), and the pooled proportion of B-Lynch suture plus vessel ligation was 3% (95% CI = 1-6%). The pooled proportions of PPH controlled and hysterectomies were 94% (95% CI = 91-97%, I2 = 65.3%) and 7% (95% CI = 4-10%, I2 = 72.13%), respectively. Therefore, B-Lynch suture (either alone or in combination with other techniques) is a simple and effective measure to control atonic PPH.

Carbetocin for the prevention of post-partum hemorrhage after vaginal birth: a real-world application.

OBJECTIVE: To compare maternal outcomes using Carbetocin versus Oxytocin for the active management of the third stage of labor, given a temporary national shortage of Oxytocin. METHODS: We conducted a retrospective observational study on a cohort of 866 women with vaginal deliveries at our center, >36 weeks of gestation, between November 2018 and March 2019. During the shortage period, each woman received a single slow intravenous injection of Carbetocin 100 µg at delivery of the anterior shoulder, rather than Oxytocin 5 UI, as postpartum hemorrhage prophylaxis. 146 (16.9%) patients received Carbetocin versus 720 (83.1%) receiving Oxytocin. The outcomes were rates of postpartum hemorrhage, severe postpartum hemorrhage, and placental retention. RESULTS: Incidence rates of placental retention and postpartum hemorrhage were 4.9% and 9.4% respectively. Placenta retention was significantly more likely following Carbetocin administration (adjusted odds ratio 2.5; 95% confidence interval 1.2-5.0). Postpartum hemorrhage rates were not significantly different (adjusted odds ratio 1.1; 95% confidence interval 0.6-2.1), as were severe postpartum hemorrhage rates (adjusted odds ratio 0.7; 95% confidence interval 0.2-2.2). CONCLUSION: Carbetocin is as effective as Oxytocin for postpartum hemorrhage prevention. However, we would reserve it for use after placental delivery due to the increased retention rates.

Patients with resolution of low-lying placenta and placenta previa remain at increased risk of postpartum hemorrhage.

OBJECTIVE: To determine whether women who experience resolution of low placentation (low-lying placenta or placenta previa) are at increased risk of postpartum hemorrhage compared to those with normal placentation throughout pregnancy. METHODS: This was a retrospective cohort study of women who delivered at Mount Sinai Hospital between 2015 and 2019, and who were diagnosed with low-lying placenta or placenta previa on transvaginal ultrasound at the time of the second-trimester anatomical survey, with resolution of low placentation on subsequent ultrasound examination. Women undergoing second-trimester anatomical survey who had normal placentation on transvaginal ultrasound 3 days before or after the cases were randomly identified for comparison. The primary outcome was the rate of postpartum hemorrhage. Secondary outcomes included the need for a blood transfusion, use of additional uterotonic medication, the need for additional procedures to control bleeding, and maternal admission to the intensive care unit. Outcomes were assessed using a multivariable logistic regression model. RESULTS: A total of 1256 women were identified for analysis, of whom 628 had resolved low placentation and 628 had normal placentation. Women with resolved low placentation, compared to those with normal placentation throughout pregnancy, had significantly higher mean age (33.0 ± 5.4 years vs 31.9 ± 5.5 years; P < 0.01) and lower mean body mass index at delivery (27.9 ± 5.5 kg/m2 vs 30.2 ± 5.7 kg/m2 ; P < 0.01), and were more likely to have undergone in-vitro fertilization, be of non-Hispanic white race, have posterior placental location (all P < 0.01) and have private/commercial health insurance (P = 0.04). Patients with resolved low placentation vs normal placentation had greater odds of postpartum hemorrhage (adjusted odds ratio (aOR), 3.5 (95% CI, 2.0-6.0); P < 0.01), use of additional uterotonic medication (aOR, 2.2 (95% CI, 1.5-3.1); P < 0.01) and increased rates of additional procedures to control bleeding (aOR, 4.0 (95% CI, 1.3-11.9); P = 0.01). CONCLUSION: Despite high rates of resolution of low-lying placenta and placenta previa by term, women with resolved low placentation remain at increased risk of postpartum hemorrhage compared to those with normal placentation throughout pregnancy. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Second-degree atrioventricular block after administration of methylergometrine for treatment of uterine atony during cesarean section.

Mortality due to cardiovascular disease in pregnancy is a growing problem in developed countries, being nowadays the leading cause of maternal death. Within this group, the most common cause of death are congenital or acquired heart diseases, representing a challenge in the management of these patients, since the pregnancy-related physiological alterations can impair their basal condition and treatment. We present the case of a 34-year-old patient, without any relevant pathological antecedents, who developed a second-degree atrioventricular block, Mobitz type I, following the administration of methylergometrine during cesarean section due to failure to progress in labour. We emphasize the importance of considering the side effects of commonly used drugs in pregnant patients, despite rare possibility of some adverse reactions.

Efficacy of different infusion rates of oxytocin for maintaining uterine tone during elective caesarean section: A randomised double blind trial.

Most research in this field has focused on finding oxytocin doses for initiating uterine contractions. Only limited data are available regarding the optimal rate of oxytocin infusion to maintain adequate uterine tone. This randomised, double blind study included 120 healthy term pregnant patients with uncomplicated, singleton pregnancy undergoing elective caesarean section under spinal anaesthesia. Following an initial 1 IU bolus, the patients received oxytocin infusion at 1.25 IU/hour (group 1.25), 2.5 IU/hour (group 2.5) or 5.0 IU/hour (group 5) for four hours. Uterine tone was assessed as adequate or inadequate at various intervals. If found inadequate, additional uterotonics were administered. Estimated blood loss was mean (standard deviation) 499 (172) ml, 454 (117) ml and 402 (151) ml in groups 1.25, 2.5 and 5, respectively (P value groups 1.25 versus 5 = 0.012). Oxytocin infusion at 5 IU/hour resulted in a significantly lower incidence of minor postpartum haemorrhage, defined as blood loss greater than 500 ml, than 1.25 IU/hour (P = 0.009). No patient had major/severe haemorrhage (>1000 ml blood loss). No significant difference was seen in haemoglobin levels (P = 0.677) and uterine tone. Fifteen, six and nine patients, respectively, required additional oxytocin (P = 0.151). The incidence of tachycardia (P = 0.726), hypotension (P = 0.321) and nausea/vomiting (P = 0.161) was comparable. To conclude, 5 IU/hour was more effective than 1.25 IU/hour in reducing total blood loss and the incidence of minor postpartum haemorrhage. Thus 5 IU/hour appears to be an optimal oxytocin infusion rate following 1 IU slow intravenous oxytocin injection for the maintenance of adequate uterine contraction in patients undergoing elective caesarean section under spinal anaesthesia.

Does simulation improve clinical performance in management of postpartum hemorrhage?

BACKGROUND: Although simulation is now widely used to improve teamwork and communication, data demonstrating improvement in clinical outcomes are limited. OBJECTIVE: This study aimed to examine the clinical performance and outcomes associated with postpartum hemorrhage because of uterine atony following the implementation of a multidisciplinary simulation program. STUDY DESIGN: This was a prospective observational study of response to postpartum hemorrhage because of uterine atony in an academic medical center before (epoch 1: July 2017-June 2018) and after (epoch 2: July 2019-June 2020) implementing a multidisciplinary simulation program. A total of 22 postpartum hemorrhage simulations were performed from July 2018 to June 2019 involving more than 300 nursing, obstetrical, and anesthesia providers. The simulation program focused on managing postpartum hemorrhage events and improving teamwork and communication of the multidisciplinary teams. To evaluate the clinical effectiveness of the simulation program, the primary outcome was response to postpartum hemorrhage defined as the time from the administration of uterotonic medications to transfusion of the first unit of blood in the first 12 hours following delivery, comparing epoch 2 to epoch 1 following the implementation of a simulation program. Statistical analysis included the use of the Pearson chi-square test, Wilcoxon rank-sum test, Hodges-Lehmann statistic for differences, and bootstrap methods with a P value of <.05 considered significant. RESULTS: Between July 1, 2017, and June 30, 2018, there were 12,305 patients who delivered, of which 495 patients (4%) required transfusion. Between July 1, 2019, and June 30, 2020, there were 12,414 patients who delivered, of which 480 patients (4%) required transfusion. When isolating cases of postpartum hemorrhage because of uterine atony in both transfused groups, there were 157 women in the presimulation group (epoch 1) and 165 women in the postsimulation group (epoch 2), respectively. There was no difference in age, race, parity, or perinatal outcomes between the 2 epochs. Women in epoch 2 began receiving blood products significantly earlier in the first 12 hours following delivery compared with women in epoch 1 (51 [range, 28-125] minutes vs 102 [range, 32-320] minutes; P=.005). In addition, there was a significantly decreased variation in the time from the administration of uterotonic medications to transfusion of blood in epoch 2 (P=.035). Furthermore, women in epoch 2 had significantly lower estimated blood loss than women in epoch 1 (1250 [range, 1000-1750] mL vs 1500 [range, 1000-2000] mL; P=.032). CONCLUSION: The implementation of a multidisciplinary simulation program at a large academic center focusing on the management of postpartum hemorrhage was associated with an improved clinical response. Specifically, there were significantly faster times from the administration of uterotonic medications to transfusion of blood, decreased variance in the time from the administration of uterotonic medications to transfusion of blood, and lower estimated blood loss following the implementation of a simulation program. Because delay in treatment is a major cause of preventable maternal death in obstetrical hemorrhage, the results in our study provided clinical evidence that a simulation program may improve patient outcomes in such emergencies.

The interrater reliability and agreement of a 0 to 10 uterine tone score in cesarean delivery.

BACKGROUND: Postpartum hemorrhage is a leading source of maternal morbidity and mortality worldwide with uterine atony identified as the underlying cause in up to 80% of cases. Several measures have been utilized to report uterine tone. The most commonly reported measure is a 0 to 10 numeric rating scale, but this scale has not been tested for reliability or agreement between different raters. OBJECTIVE: The primary purpose of this study was to evaluate the interrater reliability and agreement of the 0 to 10 visual numeric rating scale of uterine tone during cesarean delivery. A secondary purpose was to obtain estimates of scale responsiveness and minimal clinically important difference. STUDY DESIGN: Between August and November of 2018, obstetricians used a 0 to 10 numeric rating score to independently rate uterine tone at 3 and 10 minutes after cesarean delivery by palpation of the uterus. Of note, "0" represented "no tone" and "10" represented excellent tone. Each obstetrician independently and blinded to the other's score pointed to a numeric rating scale held by the anesthesiologist through a clear sterile drape. Intraclass correlation coefficients and Bland-Altman analysis were used to assess interrater reliability and agreement, respectively. Standardized response mean and standard error of measurement were used to obtain estimates of responsiveness and minimal clinically important difference, respectively. RESULTS: A total of 82 and 84 pairs of scores were collected at 3 and 10 minutes, respectively, from pairs of 62 unique obstetricians. The mean±standard deviation difference in scores between rater 1 and rater 2 was 0.4±1.4 at 3 minutes and 0.1±1.1 at 10 minutes. Intraclass correlation coefficients for a future single rater (intraclass correlation coefficient [1, 1]) at 3 and 10 minutes were 0.67 (95% confidence interval, 0.53-0.77) and 0.61 (95% confidence interval, 0.46-0.73), and for the average between 2 future raters (intraclass correlation coefficient [1, 2]), they were 0.80 (95% confidence interval, 0.71-0.87) and 0.76 (95% confidence interval, 0.63-0.84), indicating good and excellent reliability, respectively. Bland-Altman analysis estimated 95% limit of agreement between raters of -2.4 (95% confidence interval, -3.0 to -1.9) to 3.1 (95% confidence interval, 2.6-3.7) at 3 minutes and -2.1 (95% confidence interval, -2.5 to -1.7) to 2.4 (95% confidence interval, 2.0-2.8) at 10 minutes, consistent with good interrater agreement at both time points. The standardized response mean from 3 to 10 minutes after delivery was 1.1 (n=81). Standard error of measurement was 1.0 (95% confidence interval, 0.9-1.1) at 3 minutes and 0.8 (95% confidence interval, 0.7-0.9) at 10 minutes. CONCLUSION: The 0 to 10 numeric rating scale for uterine tone demonstrated good to excellent interrater reliability with 1 and 2 raters, respectively, and good interrater agreement. The scale was responsive to within-parturient change in tone, and preliminary estimates of the minimal clinically important difference were obtained. The 0 to 10 numeric rating scale for uterine tone may be a reliable, standardized tool for future research in reporting degree of uterotonic contraction during cesarean delivery.

The new clinical application of bilateral-contralateral cervix clamp in postpartum hemorrhage: a retrospective cohort study.

BACKGROUND: To assess the efficacy and safety of bilateral-contralateral cervix clamp firstly applied in postpartum hemorrhage caused by uterine tony of lower segment. METHODS: Totally 47 pregnant women with postpartum hemorrhage secondary to lower uterine segment atony in vaginal delivery or after caesarean delivery were included from March 1, 2020 to May 31, 2020. According to patient's informed consent, 22 women accepted cervical clamp to treat and 25 only used uterotonics in control group. Then hemostatic efficacy and safety of bilateral-contralateral cervix clamp were assessed by retrospective analysis. RESULTS: It was found that mean blood loss in clamp group was much less during vaginal delivery (656.2±72.79 g vs 811.8±86.07 g, p = 0.001) or after caesarean delivery (42.8±6.60 g vs 126.3±86.97 g, p = 0.007), and incidence of uterotonic repeated usage (81.8% vs 36, 18.2% vs 64%, p = 0.001) or side effect (18.2% vs 48.0%, p = 0.031) appeared less than control group, but there was no statistical differences on hospital stay (4.1±1.57 days vs 3.8±1.61 days, p = 0.535), hemoglobin (119±4.10 g vs 121.4±4.19 g, p = 0.058), blood transfusion (9.1% vs 12%,p = 0.746), surgical procedures (4.5% vs 4.0%, p = 0.93), also no clamp complications occurred. CONCLUSIONS: The bilateral-contralateral cervix clamp was effective and safe, this new technique could be a complementary treatment for postpartum hemorrhage.

A randomized controlled trial of methylergonovine prophylaxis after dilation and evacuation abortion.

OBJECTIVE: To evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20-24 weeks. STUDY DESIGN: We performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects. RESULTS: From March 3, 2015 to March 31, 2017, we randomized 284 participants (n = 140 methylergonovine, n = 144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p = 0.5). Methylergonovine recipients required more intrauterine balloon use (n = 20 [14%]) versus placebo (n = 10 [7%]), p = 0.04. We also observed a non-significant trend towards more uterotonic administration (n = 56 [40%] versus n = 43 [30%], p = 0.07) and hospital admissions for bleeding (n = 4 [3%] versus n = 0, p = 0.06) in the methylergonovine group compared to placebo. CONCLUSION: We observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E. IMPLICATIONS: When administered prophylactically immediately after dilation and evacuation abortion at 20-24 weeks, methylergonovine increases uterine bleeding. Given the lack of data for effectiveness as a prophylactic agent and our findings indicating harm, we do not recommend its use for post-operative prophylaxis.

Efficacy and safety of controlled-release dinoprostone vaginal delivery system (PROPESS) in Japanese pregnant women requiring cervical ripening: Results from a multicenter, randomized, double-blind, placebo-controlled phase III study.

AIM: To evaluate the efficacy and safety of dinoprostone vaginal insert (PROPESS) in pregnant post-term Japanese women requiring cervical ripening. METHODS: This randomized, double-blind, placebo-controlled study included 114 pregnant Japanese women at term (41 weeks of gestation) requiring cervical ripening (baseline Bishop score (BS) ≤ 4). The primary end-point was the proportion of subjects with successful cervical ripening defined as BS ≥ 7 or vaginal delivery in 12 h. The secondary end-points were changes in BS, proportion of women with vaginal delivery, proportion of women receiving mechanical cervical ripening procedure and use of oxytocic drugs. RESULTS: PROPESS administration for a maximum of 12 h showed significantly higher successful cervical ripening rate (47.4% vs 14.3%, respectively; treatment contrast [TC]: 33.1%; P = 0.0002). The median time from administration to vaginal delivery was significantly shorter in the PROPESS group than in the placebo group (26.18 h vs 33.02 h; OR 2.51; 95% CI [1.60-3.92]; P < 0.0001). In the PROPESS group, the dosage of uterotonic drugs, such as oxytocin, decreased, and the number of patients who used these drugs also decreased. CONCLUSION: PROPESS administration for a maximum of 12 h was an effective and well-tolerated treatment for pregnant Japanese women post-term requiring cervical ripening.

Storage conditions of oxytocin in a tropical climate in a low-income country.

OBJECTIVE: To establish the storage conditions of oxytocin in a health facility in a low-income country with a tropical climate, as suboptimal storage may lead to ineffectiveness of drugs essential to prevent and treat postpartum hemorrhage. METHODS: At Mulago National Referral Hospital (28 000-33 000 deliveries/year) in Kampala, Uganda, temperature logging Safe-Rx cards were placed in boxes of oxytocin and in every known storage location. The route of the boxes through the hospital was tracked for 54 days, and storage conditions were observed. RESULTS: Oxytocin was stored within the recommended temperature range (2°C-8°C) 24% of the time. The average temperature measured within the oxytocin boxes was 18.2°C, with a minimum of -2.3°C and maximum of 30.4°C. Six out of twelve known storage places had a refrigerator, but not one location stored medication at the recommended temperature constantly. The average temperature in the storage places ranged from 9.5°C to 27.6°C, with a minimum temperature of 2.3°C and maximum of 30.9°C. CONCLUSION: Oxytocin is not stored in the recommended temperature range for the majority of time. The presence of refrigerators does not ensure adherence to advised temperature storage conditions.

Oxytocin at elective caesarean delivery: a dose-finding study in women with obesity.

Prophylactic oxytocin administration at the third stage of labour reduces blood loss and the need for additional uterotonic drugs. Obesity is known to be associated with an increased risk of uterine atony and postpartum haemorrhage. It is unknown whether women with obesity require higher doses of oxytocin in order to achieve adequate uterine tone after delivery. The purpose of this study was to establish the bolus dose of oxytocin required to initiate effective uterine contraction in 90% of women with obesity (the ED90 ) at elective caesarean delivery. We conducted a double-blind dose-finding study using the biased coin up-down design method. Term pregnant women with a BMI ≥ 40 kg.m-2 undergoing elective caesarean delivery under regional anaesthesia were included. Those with conditions predisposing to postpartum haemorrhage were not included. Oxytocin was administered as an intravenous bolus over 1 minute upon delivery of the fetus. With the first woman receiving 0.5 IU, oxytocin doses were administered according to a sequential allocation scheme. The primary outcome measure was satisfactory uterine tone, as assessed by the operating obstetrician 2 minutes after administration of the oxytocin bolus. Secondary outcomes included the need for rescue uterotonic drugs, adverse effects and estimated blood loss. We studied 30 women with a mean (SD) BMI of 52.3 (7.6) kg.m-2 . The ED90 for oxytocin was 0.75 IU (95%CI 0.5-0.93 IU) by isotonic regression and 0.78 IU (95%CI 0.68-0.88 IU) by the Dixon and Mood method. Our results suggest that women with a BMI ≥ 40 kg.m-2 require approximately twice as much oxytocin as those with a BMI < 40 kg.m-2 , in whom an ED90 of 0.35 IU (95%CI 0.15-0.52 IU) has previously been demonstrated.