Severe Primary Postpartum Haemorrhage Research Articles

Primary postpartum haemorrhage adversely impacts breastfeeding initiation in Victoria, Australia

ProblemBreastfeeding has many important benefits for both mother and baby but sustained breastfeeding is sub-optimal. BackgroundIdentifying women who need increased support to establish breastfeeding has the potential to improve this. Analysis of the relationship between primary postpartum haemorrhage (PPH) and primary severe PPH and breastfeeding may prove informative as PPH has potentially negative impacts on breastfeeding. AimTo determine the relationship between PPH and severe PPH and breastfeeding at postnatal discharge and formula use for breastfed babies in hospital. MethodsPopulation-based retrospective cohort study using the Victorian Perinatal Data Collection for all liveborn singleton births at ≥ 37 weeks’ gestation (n = 339,854) for 2009–13 in Victoria. Estimated blood loss was categorised as PPH ≥ 500 mL and severe PPH ≥ 1500 mL. Descriptive analysis was conducted and multivariable logistic regression was used to determine the adjusted odds ratio for the relationship between PPH/severe PPH and breastfeeding outcomes after adjustment for relevant confounders. FindingsOverall, 94.9% of women initiated breastfeeding. Babies whose mother had a PPH or severe PPH were less likely than others to be exclusively breastfeeding at discharge (aOR 0.88; (95% CI 0.86, 0.90) and aOR 0.57; (95% CI 0.53, 0.61) respectively). Formula – given to 25.9% of all breastfed babies – was more likely for those whose mothers had a PPH or severe PPH (aOR 1.15; (95% CI 1.12, 1.17) and aOR 2.15; (95% CI 2.01, 2.29) respectively. ConclusionsWomen have greater challenges establishing exclusive breastfeeding following PPH and severe PPH. Improving support in hospital for women following PPH may increase breastfeeding success.

Hysterectomy following severe primary postpartum hemorrhage: A five year review in Abidjan University Hospitals.

Hemostasis hysterectomy is a mutilating technique responsible for definitive side effect on the woman's fertility. The aim was to document to document hemostasis hysterectomies performed in obstetrics units of university hospitals in Côte d'Ivoire. This was a retrospective, cross-sectional, and descriptive study from January 2013 to January 2018 in the three university hospital centers of Abidjan. It involved all parturients of the said university hospital centers who presented a severe postpartum hemorrhage and in whom a hemostasis hysterectomy was performed. The overall frequency of hemostasis hysterectomy in the three university hospitals was 0.32%. The most common etiologies were atony and uterine rupture. Hemostasis hysterectomy was indicated immediately. The deaths recorded were most often intraoperative and in the immediate postoperative period. The reduction of its incidence requires a good surveillance of the third period of delivery.

Implementation of a Guideline of Early Administration of Tranexamic Acid for Severe Primary Postpartum Hemorrhage: A Retrospective Comparative Study

(Aust N Z J Obstet Gynaecol. 2021;61:354–359. [Epub December 22, 2020]) Severe postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. Tranexamic acid (TXA) is commonly administered to nonobstetric patients to help manage hemorrhage. The World Maternal Antifibrinolytic (WOMAN) trial conducted in women with PPH reported that TXA had no effect on all-cause mortality; however, the trial mostly conducted in low-resource settings. This study aimed to determine whether administering 1 g of TXA intravenously during active PPH (blood loss ≥1000 mL) impacted the rate of maternal morbidity.

Effectiveness of Pre-operative Rectal Misoprostol in Reducing Blood Loss during Cesarean Section for Placenta Previa and Manual Removal of Retained Placenta: A Parallel Placebo-Controlled Study

BACKGROUND: Primary postpartum hemorrhage (PPH) contributes significantly to the high maternal mortality ratio, especially in the low resource nations. Placenta previa and retained placenta are major causes of postpartum hemorrhage. Uterotonics like misoprostol are medication used to improve uterine contractility with the purpose of reducing uterine bleeding after delivery of baby. Most studies on misoprostol for the prevention of obstetric hemorrhage have been focusing on its postpartum use.
 AIM: The aim of this study was to assess the effectiveness of pre-operative misoprostol in reducing blood loss during cesarean section for placental previa and manual removal of retained placenta.
 METHODS: This was a placebo-controlled study involving 154 women who were randomly assigned to the treatment and control groups. The study group received 400 ug of misoprostol rectally just before the commencement of the procedure. Estimation of blood loss was done in a standardized way. Data were analyzed using SPSS version 23. The level of significance was set at p < 0.05.
 RESULTS: The average age of the participants was 31.64 years. The overall incidence of PPH was comparable in both groups (0.070), however, misoprostol group experienced lower incidence of severe PPH compared to the placebo (p = 0.013). Other maternal and perinatal outcomes were comparable.
 CONCLUSION: Excessive intraoperative and immediate post-operative bleeding can be prevented with pre-operative misoprostol. It should be made available for high-risk obstetrics procedures.

Implementation of a guideline of early administration of tranexamic acid for severe primary postpartum haemorrhage: a retrospective comparative study.

Since the WOMAN trial, intravenous tranexamic acid (TXA) has been increasingly used in severe postpartum haemorrhage (PPH) but research evaluating use in high-income settings is limited. To assess whether implementation of a new guideline involving early administration of 1 g intravenous TXA in active PPH with blood loss ≥1000 mL, was associated with a change in maternal morbidity. Retrospective study of all singleton, term, vaginal births from November 2016 to June 2019 with a PPH of ≥1000 mL, before and after hospital adoption of a guideline recommending early (within three hours of birth) administration of TXA for women with active PPH ≥1000 mL. Univariate analysis assessed the impact of this guideline implementation on a primary outcome of maternal morbidity, defined as one or more of haemoglobin <90g/L, administration of blood products, hysterectomy or intensive care admission. Secondary outcomes were adverse events related to administration of TXA, use of an intrauterine balloon or postpartum iron infusion. There was no difference in morbidity (odds ratio (OR) 0.86, 95% CI 0.57-1.29, P=0.46) or postpartum iron infusion (OR 1.44, 95% CI 0.92-2.27, P=0.11), but there was a reduction in the use of intrauterine balloon tamponade after the implementation of the TXA guideline (OR 0.33, 95% CI 0.16-0.67, P<0.01). This retrospective analysis showed a reduced use of intrauterine balloon but failed to show a benefit in maternal morbidity with early administration of TXA for severe postpartum haemorrhage in a high-income setting.

Incidence and Pregnancy Outcomes of Primary Postpartum Hemorrhage Following Implementation of Postpartum Drape with a Calibrated Bag after Normal Vaginal Delivery

Objective: To evaluate the incidence, risk factors, and pregnancy outcomes of primary postpartum hemorrhage (PPH) after the implementation of postpartum drape with a calibrated bag (PDCB) after normal vaginal delivery.Methods: This retrospective chart review compared patients who had normal vaginal delivery in June 2012 prior to PDCB implementation with patients who had normal vaginal delivery in June 2014 after PDCB implementation at Siriraj Hospital.Results: In total, 856 patients were included in this study, with 458 and 398 patients delivered in June 2012 and June 2014, respectively. Baseline characteristics were comparable between the two groups. The incidence of primary PPH increased significantly after the implementation of PDCB (2.8% in 2012 vs. 8.5% in 2014; p &lt; 0.01). The incidence of severe PPH was also significantly increased (0.4% in 2012 vs. 2.3% in 2014; p = 0.02). Uterine atony was the most common cause and the diagnosis increased after PCDB implementation. The use of additional uterotonic drugs was also significantly increased after PDCB implementation (30.8% in 2012 vs. 85.3% in 2014; p &lt; 0.01). The blood transfusion rate was comparable between the two groups. No peripartum hysterectomy or ICU admission was observed in this study. After PDCB implementation, pregnancy-induced hypertension was found to be a significant risk factor for primary PPH (p &lt; 0.01).Conclusion: The incidence of primary and severe PPH, and the rate of the use of additional uterotonic drugs were all significantly increased after the implementation of PDCB. Pregnancy-induced hypertension was found to be a significant risk factor for primary PPH.

A double-blind randomized controlled clinical trial of oral misoprostol versus ergometrine in the prevention of primary postpartum hemorrhage

Objective: The study was designed to investigate the effectiveness of orally administered misoprostol versus intravenous ergometrine (stored at tropical temperatures) in the prevention of primary postpartum hemorrhage (PPH) among parturients undergoing vaginal delivery in a teaching hospital.Study Design: A double-blind randomized controlled clinical trial was conducted at the University of Benin Teaching Hospital. One hundred and fifty parturients were offered 400 ug misoprostol and an intravenous placebo for the management of the third stage of labor while another 150 parturients received oral placebo and 0.5 mg intravenous ergometrine.Results: There was no significant difference in the incidence of PPH (blood loss > 500 ml) between the two groups: 8 (5.3%) for the misoprostol group compared with 7 (4.7%) for the ergometrine group (P = 0.79, relative risk (RR) = 1.07, confidence interval (CI): 0.66–1.74). The incidence of severe PPH (blood loss > 1000 ml) was similar between the two groups: 2 (1.3%) in the misoprostol group compared with 1 (0.7%) in the ergometrine group. Similarly, the indices of postpartum blood loss (hematocrit change, need for blood transfusion, and surgical intervention) were comparable between the two groups. A subgroup analysis of high-risk parturients revealed comparable indices. The misoprostol group, however, had a significantly higher risk of shivering in the early postpartum period (P = 0.00, RR = 2.01, CI: 1.69–2.38).Conclusions: The results suggest that oral misoprostol has comparable efficacy to intravenous ergometrine at tropical conditions in the prevention of PPH. However, in view of its easier mode of administration, oral misoprostol may be preferable in rural situations in Africa.

Active versus expectant management for women in the third stage of labour.

Active versus expectant management for women in the third stage of labour.

Efficacy of Intravenous Tranexamic Acid in Reducing Blood Loss after Elective Cesarean Section

Background: Primary post-partum hemorrhage (PPH) is defined as blood loss greater than or equal to 500 ml within 24 hours after birth, while severe PPH is blood loss greater than or equal to 1000 ml within 24 hours. Objective: was to determine the efficacy and safety of tranexamic acid in reduction of blood loss after the elective cesarean sections. Patients and Methods: We performed a randomized, controlled study of 200 pregnant females who underwent elective CS. The patients had attended the Labor Ward in Al-Azhar University Maternity Hospital. 100 of them received tranexamic acid 20 minutes before beginning of anesthesia in addition to oxytocin after delivery of the baby; the other 100 patients received oxytocin only. Results: In the 1st two hours post-partum vaginal bleeding was significantly less severe in study group than control group (p<0.019). There was nonsignificant difference between study and control groups as regards preoperative hemoglobin concentration (p=0.195), Postoperative hemoglobin concentration was significantly greater in study group than control group (p<0.001), Reduction in hemoglobin levels ware significantly less in study group than control group (p<0.001). There was nonsignificant difference between study and control groups as regards to preoperative hematocrite (p=0.967), Postoperative hematocrite levels were significantly higher in study group than control group (p0.015), Reduction in hematocrite levels ware significantly less in study group than control group (p<0.001).

Efficacy of Intravenous Tranexamic Acid in Reducing Blood Loss after Elective Cesarean Section

Background: Primary post-partum hemorrhage (PPH) is defined as blood loss greater than or equal to 500 ml within 24 hours after birth, while severe PPH is blood loss greater than or equal to 1000 ml within 24 hours. Objective: was to determine the efficacy and safety of tranexamic acid in reduction of blood loss after the elective cesarean sections. Patients and Methods: We performed a randomized, controlled study of 200 pregnant females who underwent elective CS. The patients had attended the Labor Ward in Al-Azhar University Maternity Hospital. 100 of them received tranexamic acid 20 minutes before beginning of anesthesia in addition to oxytocin after delivery of the baby; the other 100 patients received oxytocin only. Results: In the 1st two hours post-partum vaginal bleeding was significantly less severe in study group than control group (p<0.019). There was nonsignificant difference between study and control groups as regards preoperative hemoglobin concentration (p=0.195), Postoperative hemoglobin concentration was significantly greater in study group than control group (p<0.001), Reduction in hemoglobin levels ware significantly less in study group than control group (p<0.001). There was nonsignificant difference between study and control groups as regards to preoperative hematocrite (p=0.967), Postoperative hematocrite levels were significantly higher in study group than control group (p0.015), Reduction in hematocrite levels ware significantly less in study group than control group (p<0.001).

Incidence, trends and severity of primary postpartum haemorrhage in Australia: A population-based study using Victorian Perinatal Data Collection data for 764244 births.

Increasing incidence and severity of postpartum haemorrhage, together with postpartum haemorrhage-associated morbidities, have been reported in many high-resource countries. In-depth analysis of such factors in Victorian births since 2002 was lacking. Our aim was to determine the incidence and trends for primary postpartum haemorrhage (World Health Organization and International Classification of Diseases 10th revision, Australian Modification definitions) for all confinements in Victoria, Australia, for the years 2003-2013 and the incidence and trends for severe postpartum haemorrhage (≥1500mL) for 2009-2013. In this population-based cross-sectional study de-identified data from the Victorian Perinatal Data Collection were analysed for confinements (excluding terminations) from 2003 to 2013 (n=764244). Perinatal information for all births ≥20weeks (or of at least 400g birthweight if gestation was unknown) were prospectively collected. One in five women (21.8%) who gave birth between 2009 and 2013 experienced a primary postpartum haemorrhage and one in 71 women (1.4%) experienced a severe primary postpartum haemorrhage. The increasing trends in incidence of primary postpartum haemorrhage, severe primary postpartum haemorrhage, blood transfusion, admission to an intensive care or high dependency unit and peripartum hysterectomy were significant (P<0.001). Women who had an unassisted vaginal birth had the lowest incidence of primary postpartum haemorrhage. The highest incidence was experienced by women who had an unplanned caesarean section birth. Women who had a forceps birth had the highest incidence of severe primary postpartum haemorrhage. The incidence of primary postpartum haemorrhage, severe primary postpartum haemorrhage and associated maternal morbidities have increased significantly over time in Victoria.

158: Predictors of failed intrauterine balloon tamponade for persistent primary postpartum hemorrhage after vaginal delivery

To determine predictors of failed intrauterine balloon tamponade (IUBT) for persistent primary postpartum hemorrhage (PPH) after vaginal delivery. This was a retrospective survey in five hospitals in a French perinatal network. All women who underwent IUBT for persistent PPH after vaginal delivery in these hospitals from 2011-2015 were included. All maternity belong to the same perinatal network and apply the same management policy for PPH. IUBT, using a Bakri balloon (Cook Medical, Bloomington, IN, USA), was used as a second line therapy for persistent PPH after failure of uterine massage and uterotonic agents to stop bleeding. Women were identified in the hospital discharge database. Women in the case group were defined as women who had IUBT but required another second line therapy (embolization or surgical procedures) to stop bleeding, and women whom IUBT stopped bleeding were defined as control group. Univariate and logistic regression analyses were performed to determine independent predictors for failed IUBT. The study was approved by the French Ethics Review Committee (No. CEROG OBS 2016-03-28) and we obtained informed consent from the women. During the study period, there were 91,880 deliveries in the 5 hospitals, and 1,367 persistent PPH after vaginal delivery (1.5%) were registered. IUBT was used in 108 women (7.9%) to control PPH. Bleeding stopped after IUBT in 80 women (74.1%). In 28 women, invasive procedures were required, including 19 embolization and 9 surgical procedures with 5 peripartum hysterectomies. Women with failed IUBT were more often obese (BMI ≥ 30 kg/m2) (25.9% vs. 8.1%; P=.03), duration of labor was shorter (363.9 min vs. 549.7min, P=.04), and severe PPH (blood loss>1,500 mL) before IUBT was more frequent (64% vs. 40%; P=.04). In the multivariable logistic regression analysis (adjusted for maternal age, BMI before pregnancy, and blood loss), maternal obesity was a predictive factor of failed IUBT (aOR 4.40, CI95% 1.06-18.31). Severe PPH before IUBT seemed to be another predictor of failure (aOR 1.001, CI95% 1.000-1.002; P=.055), but our result did not reach statistical significativity. Intrauterine balloon tamponade is an effective second line therapy for persistent PPH after vaginal delivery. Maternal obesity and delayed use of the device are the main risk factors of failure.

Defining definitions: a Delphi study to develop a core outcome set for conditions of severe maternal morbidity.

Develop a core outcome set of international consensus definitions for severe maternal morbidities. Electronic Delphi study. International. Eight expert panels. All 13 high-income countries represented in the International Network of Obstetric Surveillance Systems (INOSS) nominated five experts per condition of morbidity, who submitted possible definitions. From these suggestions, a steering committee distilled critical components: eclampsia: 23, amniotic fluid embolism: 15, pregnancy-related hysterectomy: 11, severe primary postpartum haemorrhage: 19, uterine rupture: 20, abnormally invasive placentation: 12, spontaneous haemoperitoneum in pregnancy: 16, and cardiac arrest in pregnancy: 10. These components were assessed by the expert panel using a 5-point Likert scale, following which a framework for an encompassing definition was constructed. Possible definitions were evaluated in rounds until a rate of agreement of more than 70% was reached. Expert commentaries were used in each round to improve definitions. Definitions with a rate of agreement of more than 70%. The invitation to participate in one or more of eight Delphi processes was accepted by 103 experts from 13 high-income countries. Consensus definitions were developed for all of the conditions. Consensus definitions for eight morbidity conditions were successfully developed using the Delphi process. These should be used in national registrations and international studies, and should be taken up by the Core Outcomes in Women's and Newborn Health initiative. Consensus definitions for eight morbidity conditions were successfully developed using the Delphi process.

Postpartum Hemorrhage in Women with Von Willebrand Disease - A Retrospective Observational Study.

Introductionvon Willebrand disease (VWD) is a hereditary bleeding disorder, caused by a deficiency in the levels and/or function of von Willebrand factor (VWF). Women with VWD appear to be at increased risk of experiencing postpartum hemorrhage (PPH), though the levels of VWF increase during pregnancy. There is limited knowledge of how PPH is associated with the subtype of VWD, plasma levels of other coagulations factors than VWF and given hemostatic treatment.AimsThe aims were to investigate the incidence of PPH in women with VWD and to analyse the correlation between PPH and: (1) type of VWD, (2) laboratory monitoring of VWF and FVIII and (3) hemostatic drug treatment.MethodsThis was a retrospective observational study. The study participants (n = 34) were recruited from the Coagulation Unit, Karolinska University hospital. Fifty-nine deliveries, which occurred in 14 different obstetrics units (years 1995–2012) were included in the study.ResultsThe incidence of primary PPH was 44%, severe primary PPH 20% and secondary PPH 12%. VWD type 3 was associated with a higher risk of experiencing severe primary PPH compared to other subtypes. FVIII:C in pregnancy was inversely correlated to blood loss during delivery. There was a significantly higher incidence of secondary PPH when the VWD diagnosis was unknown at time of delivery.ConclusionsThe women with VWD are at higher risk of PPH, especially those with type 3 VWD or when diagnosis is unknown prior to delivery. Identification of pregnant women with undiagnosed VWD may be of importance in order to prevent PPH.

Predictors of severity in primary postpartum hemorrhage.

To identify risk factors and etiologies leading to severe primary postpartum hemorrhage (PPH) in women with PPH. Women who experienced PPH within the first 24 h after delivery over a 3-year period were retrospectively evaluated. Patients were divided into two groups on the basis of severe PPH (n = 125) or non-severe PPH (n = 411). Risk factors and etiologies for severe PPH were explored using univariate and multivariate logistic regression analyses. PPH and severe PPH complicated 2.1 and 0.49 % of all deliveries, respectively. Previous cesarean delivery (OR = 3.15, 95 % CI = 1.02-10.3; p = 0.001), prolonged labor (OR = 3.62, 95 % CI = 3.21-4.03; p < 0.001), oxytocin augmentation (OR = 3.32, 95 % CI 2.05-5.93; p < 0.001) and emergency cesarean delivery (OR = 4.75, 95 % CI 1.32-12.96; p < 0.001) were the factors independently associated with severe PPH. Etiologies significantly associated with severe PPH are uterine atony (OR = 2.72, 95 % CI 1.64-4.55; p < 0.001) and abnormal placentation (OR = 3.05, 95 % CI 1.56-6.27; p = 0.006). Previous cesarean delivery, prolonged labor, oxytocin augmentation and emergency cesarean delivery are strongest predictors of severe blood loss in women with PPH. In addition, uterine atony and abnormal placentation are the etiologies significantly associated with severe PPH.

Rethinking WHO guidance: review of evidence for misoprostol use in the prevention of postpartum haemorrhage

This article describes and critically appraises clinical trials assessing misoprostol effectiveness in preventing primary postpartum haemorrhage (PPH) in home and community settings in low- and middle-income countries. Of 172 identified studies of misoprostol use in labour only six fulfilled the inclusion criteria. All trials used 600 μg misoprostol in the intervention arm; three assessed misoprostol alongside components of active management of the third-stage labour (AMTSL), two used expectant management of labour and one allowed birth attendants to choose management practice. The three AMTSL studies showed no significant differences in PPH incidence or referral to higher centres and only one study showed significant decrease in severe PPH using misoprostol. One expectant management study and the choice of management by birth attendants study found significant decreases in PPH incidence with misoprostol. All studies showed significantly increased risk of shivering with misoprostol. Studies were biased by use of alternative uterotonics in the control arm, confounding management practices, and subjective assessment and, with one exception, exclusion of high-risk women. PPH incidence fell in both the control and intervention groups in both the landmark papers that informed the World Health Organization (WHO) decision to admit misoprostol to the Essential Medicines List. This suggests factors other than misoprostol use are crucial. Current evidence does not support misoprostol use in home and community settings in low- and middle-income countries for PPH prevention. WHO should rethink its recent decision to include misoprostol on the Essential Medicines List.

Efficacy of B-Lynch Brace Suture in Postpartum Haemorrhage

Introduction: Massive uncontrolled haemorrhage after childbirth is the leading cause of maternal death in developing countries. Postpartum haemorrhage is traditionally defined as blood loss of more than 500 ml after vaginal delivery and more than 1000 ml after cae-sarean section, but intra-operative estimation of blood loss is inaccurate. Uterine atony alone accounts for 75 - 90% of PPH. Objectives: To estimate the effectiveness and safety of B-Lynch brace Suture in the management of pri-mary postpartum haemorrhage (PPH). If at all, to asse-ss the complications due to this procedure during the next three days. Study Design: Case series descriptive study. Setting: Study was carried out in the department of Gynaecology and obstetrics, Unit II, Jinnah Hospital, Lahore. Duration of Study: The study was completed in six months from 8 - 6 - 2006 to 8 - 12 - 2006. Subjects and Methods: Total sixty patients were included in this study. Condition of the uterus and con-dition of the cervical os was assessed. B-Lynch suture was applied in suitable cases. Results: Mean age of the patients was found to be 28.8 ± 4.9. Distributions of successfulness of B-Lynch suture showed 57 (95%) successful patients.10% were stated in the state of shock. 11.7% with eclampsia and 53.3% were presented with fetal distress. Conclusions: B-Lynch compression suture is easy to apply and should be considered primary treatment in cases of severe atonic PPH when oxytocic agents fai-led, and before resorting to hysterectomy. Keywords: Postpartum haemorrhage, uterine atony, B-Lynch Suture.

Use of Recombinant Activated Factor VII in Severe Post-Partum Haemorrhage: Data From the Italian Registry. A Multicentric Observational Retrospective Study.

Abstract 4434 IntroductionMajor Post-Partum Haemorrhage (PPH) is a life-threatening labour complication, which mainly occurs without warning, predictive signs or symptoms and often in absence of predisposing conditions. Severe PPH is defined by an estimated blood loss during the first 24 hours post-partum, of more than 500mL in case of natural delivery and of more than 1000mL in case of caesarean section. In developed countries PPH incidence is reported between 0.5% and 2%. In these countries it is the third cause of maternal mortality, after venous thromboembolism (VTE) and hypertension. In developing countries, major PPH is cause of 120-000-150.000 maternal deaths every year. Therapeutic strategies for severe PPH management are largely standardized. Recombinant activated factor VII (rFVIIa) is an activated factor VII form, produced from factor VII cDNA transfected into hamster kidneys. The first case of rFVIIa administration during perioperative bleeding has been reported in 1999, since this time rFVIIa has been used as adjunctive therapy in the management of patients with life-threatening and critical haemorrhages caused by trauma, abdominal or cardiac surgery or urological surgery, liver transplantation, post partum and any other bleeding condition leading to impairment of haemostasis PurposeTo report the Italian real experience in clinical practice, in order to provide wide and detailed clinical information about use of rFVIIa in the management of massive primary PPH in our country and in order to evaluate the role of haemostatic therapy in the management of this severe life- threatening obstetric complication, so contributing to treatment protocols development. MethodsAn Italian retrospective survey of severe primary PPH cases treated with rFVIIa was performed. Anamnestic, clinical and haemostatic data about fourty-three patients with PPH, from 2005 to 2007, were collected. Coagulative parameters and transfusion requirements before and after rFVIIa treatment were compared. ResultsAfter rFVIIa administration INR was significantly decreased, while fibrinogen levels were markedly increased. Median of packed red blood cells units, platelets units, fresh frozen plasma, crystalloids and colloids needed, before and after rFVIIa administration, were significantly decreased (tab.1). Thirty-four of 43 patients needed surgical intervention before rFVIIa administration, 11/43 after treatment. Hysterectomies have been performed respectively in 12/43 cases before and in 7/43 cases after rFVIIa infusion. The response to rFVIIa is shown in table 2 No maternal deaths have been reported. No adverse events or thromboembolic complications were observed.Table 1Transfusion requirements.BEFORE rFVIIa median [range]AFTER rFVIIa median [range]MEDIAN REDUCTION FOLLOWING rFVIIa (%)pRBC units [range]6 [1-38]2 [0-7]66,7<1.2exp-6PLT units [range]1.5 [0-13]0 [0-6]100<0.001FFP ml [range]1250 [0-10500]0 [0-4500]100<4.4exp-5*Colloids and crystalloids ml [range]3000 [0-16500]1250 [0-3750]58,3<0,0042*impossible to determine ratio of colloids and crystalloids, data not present in CRF.Tab. 2Reponse to rFVIIa% of patients (nr. of cases)COMPLETE RESPONSE (reduction>90%)51.2 (22/43)MAJOR RESPONSE (reduction 50%-9027.9 (12/43)MINOR RESPONSE (reduction 30%-50%)9.3 (4/43)NO RESPONSE (reduction <30%)11.6 (5/43) ConclusionrFVIIa administration represents a safe haemostatic approach in the management of severe PPH cases, when other conventional medical, surgical and radiology interventional approaches have not been successful. Data from Italian Registry, as well as from other case series, demonstrate the rFVIIa efficacy to reduce or stop obstetric critical bleeding. The use of rFVIIa as lifesaving therapy in cases, in which medical and surgical standard approach have failed, should be always considered as life well as uterus lifesaving treatment. Disclosures:Off Label Use: Safety and efficacy of rFVIIa in postpartum hemorrhage.

Use of recombinant activated factor VII in severe post-partum haemorrhage: Data from the Italian Registry: A multicentric observational retrospective study

Purpose To report the Italian real experience in clinical practice about recombinant factor VII activated (rFVIIa) in Post-Partum Haemorrhage (PPH) treatment. Methods An Italian retrospective survey of severe primary PPH cases treated with rFVIIa was performed. Anamnestic, clinical and haemostatic data about thirty-five patients with PPH, from 2005 to 2007, were collected. Coagulative parameters and transfusion requirements before and after rFVIIa treatment were compared. Results After rFVIIa administration INR was significantly decreased, while fibrinogen levels were markedly increased. Median of packed red blood cells units, platelets units, fresh frozen plasma, crystalloids and colloids needed, before and after rFVIIa administration, were respectively 6 and 2 units (p < 1.2exp-6), 1.5 and 0 units (p = 0.001), 1250 and 0 mL (p < 4.4exp-5), 3000 and 1250 mL (p < 0,0042). Twenty-nine of 35 patients needed surgical intervention before rFVIIa administration, 9/35 after treatment. Hysterectomies have been performed respectively in 10/35 cases before and in 6/35 cases after rFVIIa infusion. No maternal deaths have been reported. No adverse events or thromboembolic complications were observed. Conclusions Our clinical and haemostatic data suggest that recombinant activated factor VII may be a safe and helpful adjunctive therapy in the PPH management.

Severe primary postpartum hemorrhage due to genital tract laceration after operative vaginal delivery: successful treatment with transcatheter arterial embolization

The purpose of this study was to report our experience in the management of severe primary postpartum hemorrhage due to genital tract laceration following operative vaginal delivery with forceps using pelvic transcatheter arterial embolization (TAE). Ten women (mean age, 31.9 years) with severe primary postpartum hemorrhage due to genital tract laceration after operative delivery with forceps were treated with TAE. TAE was indicated because of intractable bleeding that could not be controlled with uterotonic drugs, blood transfusion, attempted suturing and packing in all patients. Postdelivery perineal examination showed cervical or vaginal tears in all women and associated paravaginal hematoma in four. Angiography revealed extravasation of contrast material in six patients. TAE performed with gelatin sponge allowed to control the bleeding in all patients. Cervical and vaginal suturing was made possible and successfully achieved in the six women who had failed suturing attempts before TAE. Paravaginal hematoma was successfully evacuated in four patients in whom it was present after TAE. No complications related to TAE were noted. We conclude that in women with severe primary postpartum hemorrhage due to genital tract laceration after operative delivery with forceps, TAE is effective and safe for stopping the bleeding and helps genital tract suturing and evacuation of hematoma.