Abstract Background Intrauterine fetal death (IUFD) is a tragic event and, despite efforts to reduce rates, its incidence remains difficult to reduce. The objective of the present study was to ...examine the etiological factors that contribute to the main causes and conditions associated with IUFD, over an 11-year period in a region of North-East Italy (Friuli Venezia Giulia) for which reliable data in available. Methods Retrospective analysis of all 278 IUFD cases occurred between 2005 and 2015 in pregnancies with gestational age ≥ 23 weeks. Results The incidence of IUFD was 2.8‰ live births. Of these, 30% were small for gestational age (SGA), with immigrant women being significantly over-represented. The share of SGA reached 35% in cases in which a maternal of fetal pathological condition was present, and dropped to 28% in the absence of associated pathology. In 78 pregnancies (28%) no pathology was recorded that could justify IUFD. Of all IUFDs, 11% occurred during labor, and 72% occurred at a gestational age above 30 weeks. Conclusion The percentage of IUFD cases for which no possible cause can be identified is quite high. Only the adoption of evidence-based diagnostic protocols, with integrated immunologic, genetic and pathologic examinations, can help reduce this diagnostic gap, contributing to the prevention of future IUFDs.
Intrauterine fetal death (IUFD) is a tragic event and, despite efforts to reduce rates, its incidence remains difficult to reduce. The objective of the present study was to examine the etiological ...factors that contribute to the main causes and conditions associated with IUFD, over an 11-year period in a region of North-East Italy (Friuli Venezia Giulia) for which reliable data in available.
Retrospective analysis of all 278 IUFD cases occurred between 2005 and 2015 in pregnancies with gestational age ≥ 23 weeks.
The incidence of IUFD was 2.8‰ live births. Of these, 30% were small for gestational age (SGA), with immigrant women being significantly over-represented. The share of SGA reached 35% in cases in which a maternal of fetal pathological condition was present, and dropped to 28% in the absence of associated pathology. In 78 pregnancies (28%) no pathology was recorded that could justify IUFD. Of all IUFDs, 11% occurred during labor, and 72% occurred at a gestational age above 30 weeks.
The percentage of IUFD cases for which no possible cause can be identified is quite high. Only the adoption of evidence-based diagnostic protocols, with integrated immunologic, genetic and pathologic examinations, can help reduce this diagnostic gap, contributing to the prevention of future IUFDs.
ABSTRACT No detailed information is currently available about the management of pregnancy and delivery in patients with a stoma after colectomy for ulcerative colitis. We describe the case of a young ...pregnant woman with terminal ileostomy after toxic megacolon. Episodes of stoma occlusion, determined by the enlargement of the uterus, were treated with endoscopic decompression and daily assumption of oral laxatives, making possible to avoid surgery and carry pregnancy on until caesarean section was performed at week 37. Fertility issues, facing pregnancy with ileostomy rather than with ileal pouch-anal anastomosis, and choice of caesarean section rather than vaginal delivery are discussed.
•Importance of immunosuppressive Treg and MDSC on tumor progression.•Immunosuppression of Treg and MDSC cells by Cyclophosphamide and Fluorouracil can improve IL-2 activity.•Efficacy of ...chemo-immunotherapy in pre-treated resistant tumors.
Immune tolerance seems to correlate with disease progression and T regulatory cells (Tregs) and myeloid-derived suppressor cells play a relevant role in immunosuppression. Cyclophosphamide (Cyt) and Fluorouracil (FU) seem to reduce these cell populations.
Establishing safety, feasibility, activity and impact on the immune system (neutrophil/lymphocyte N/L, platelet/L Plt/L, monocyte M and lymphocyte subpopulation (CD3, CD4, CD8, CD16, HLADR/CD3, Tregs, cells count), CD8/Treg and C-reactive protein (CRP). Treatment: 1) Cyt 300 mg/sqm ± FU 500 mg/sqm day (d) 1 and interleukin 2 (IL-2) 18 MUI/sqm intravenous (I.V.) d 4–6, 18–20 or 2) Cyt 300 mg/sqm + FU 500 mg/sqm day d 1, IL-2 4.5 MUI subcutaneous (S.C.) d 3–6, 17–20. The cycle was repeated every four weeks for 2 cycles. Stable or responding patients (pts) continued therapy for 3 cycles.
From February 2014 to December 2016, 13/14 pre-treated pts (mean 3 lines) with solid tumors were enrolled. Male/Female: 1/1. The median age and Eastern Cooperative Oncology Group Performance Status (ECOG PS) was 68 years and 1 respectively. Mean 2 cycles of therapy were administered. G3-4 toxicities presented as diarrhea and bleeding anemia in 2 pts and proteinuria and erhytroderma in 1pt, respectively. Regarding the hematological profile, a more reduction in Plt, less decrease of Plt/Ly, and less increase of Treg with I.V. than S.C. IL-2 administration was observed. However a transient decrease of Treg on day 7 of first cycle in the I.V. IL-2 was reported.
PR 3 (23%), SD 3 (23%), PD 7 (54%). The response duration was 2+ and 3 months in 2 HCC and 18+ months in the pancreatic cancer (PC). Pathological CR was reported in one HCC treated with I.V. IL-2. The median progression-free-survival (PFS) and overall survival (OS) were 1 and 7 months.
Cyt-FU-IL-2 can be considered safe, feasible and moderately active in heavily pre-treated pts. Plt, Plt/Ly, CD8/Treg and a transient Tregs reduction were observed without significative difference on survival.
To report the Italian real experience in clinical practice about recombinant factor VII activated (rFVIIa) in Post-Partum Haemorrhage (PPH) treatment.
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.
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.
Our clinical and haemostatic data suggest that recombinant activated factor VII may be a safe and helpful adjunctive therapy in the PPH management.
Abstract 4434
Major 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
To 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.
An 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.
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 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 rangeAFTER rFVIIa median rangeMEDIAN REDUCTION FOLLOWING rFVIIa (%)pRBC units range6 1-382 0-766,7<1.2exp-6PLT units range1.5 0-130 0-6100<0.001FFP ml range1250 0-105000 0-4500100<4.4exp-5*Colloids and crystalloids ml range3000 0-165001250 0-375058,3<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)
rFVIIa 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.
Off Label Use: Safety and efficacy of rFVIIa in postpartum hemorrhage.
Abstract 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.
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