The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study.

Orthognathic surgery can cause substantial bleeding. Recent meta-analyses concluded that there is a statistically significant reduction in perioperative blood loss with the preventive use of tranexamic acid (TA). However, the mean reported difference in bleeding was moderate, and the clinical relevance of this blood-sparing effect remains debated. We therefore conducted a prospective, double-blind, randomized, placebo-controlled equivalence study of the effect of TA in patients undergoing Lefort I or bimaxillary osteotomies. Our main outcome measure was total blood loss on postoperative day 1. The equivalence margin was ± 250 ml for the difference in blood loss and its 95% confidence interval. One hundred and forty-seven patients were randomized, of which 122 underwent bimaxillary osteotomies. Blood loss in the treatment group was 682 ± 323 vs. 875 ± 492 ml. The mean difference in bleeding was -132 [-243; -21] ml as per-protocol, but -193 [-329; -57] ml in intention-to-treat: the limits of this confidence interval exceeded the margin of equivalence. Similar results were obtained when analysing only patients undergoing bimaxillary osteotomy. Haemoglobin decreased by 1.8 ± 1.2 g/dl with TA, vs. 2.6 ± 1.1 g/dl with placebo (p<0.001). Our study did not demonstrate equivalence between TA and placebo on perioperative blood loss in orthognathic surgery. TA may reduce blood loss but without evidence of clinical consequences.

[Definition of pregnancy losses: Standardization of terminology from the French National College of Obstetricians and Gynecologists (CNGOF)]. / Standardisation de la terminologie des pertes de grossesse : consensus d'experts du Collège national des gynécologues et obstétriciens français (CNGOF).

OBJECTIVE: While a number of glossaries have been produced by various authorities in different countries, at present there is no internationally accepted common set of definitions for many terms used to describe pregnancy losses. The objective of the current study was to provide a standardized French/English terminology/glossary relating to pregnancy losses. METHODS: Literature review, construction of a glossary and rating of proposals using a formal consensus method. The glossary was subject of a critical comprehensive review by a meeting of professionals (multidisciplinary panel). RESULTS: A miscarriage is a spontaneous evacuation of an intra-uterine pregnancy<22WG. A missed early miscarriage is when ultrasound (<14WG) shows no growth of intra-uterine sac/embryo and/or loss of fetal heart activity. An early miscarriage is when spontaneous evacuation of intra-uterine pregnancy occurs <14WG. A complete early miscarriage is when there is no retained products of conception (empty uterus on ultrasound) and no bleeding nor pain. Incomplete early miscarriage is when ultrasonography shows retained products of conception in the uterine cavity (including cervical canal). Repeat miscarriage or recurrent pregnancy loss is when the woman experiences 3 or more consecutive miscarriages <14WG. A late miscarriage is when there is spontaneous evacuation of pregnancy ≥14WG and <22WG. A threatened late miscarriage is when shortening/opening of the cervix±uterine contraction occur ≥14WG and <22WG. An intra-uterine fetal demise is when there is a spontaneous loss of fetal heart activity ≥14 WG. CONCLUSION: The final current terminology should be used by all healthcare professionals.

[Psychology and pregnancy loss]. / Psychologie et perte de grossesse.

OBJECTIVE: The objective of this study was to evaluate the relationship between psychology and pregnancy loss. METHODS: A literature review was conducted by consulting Medline until April 2014. RESULTS: Psychological factors appear to be significantly associated with the risk of recurrent miscarriage. Depression and anxiety are common symptoms after miscarriage. A return to normal scores of depression and anxiety is frequently found in one year. A systematic psychological treatment after an episode of miscarriage seems to not bring obvious benefits, one year after a miscarriage, in terms of anxiety and depression. After a stillbirth, psychological impacts on the couple, such as anxiety and depressive symptoms, are common. An empathetic and respectful attitude of all medical and paramedical team at the support is associated with better psychological experience. CONCLUSION: After a pregnancy loss, psychological consequences are common and usually reversible. An attitude of empathy is desirable in order to accompany patients and to consider a future pregnancy.

Evaluation of pulse pressure variation validity criteria in critically ill patients: a prospective observational multicentre point-prevalence study.

BACKGROUND: Respiratory variation in pulse pressure (ΔPP) is commonly used to predict the fluid responsiveness of critically ill patients. However, some researchers have demonstrated that this measurement has several limitations. The present study was designed to evaluate the proportion of patients satisfying criteria for valid application of ΔPP at a given time-point. METHODS: A 1 day, prospective, observational, point-prevalence study was performed in 26 French intensive care units (ICUs). All patients hospitalized in the ICUs on the day of the study were included. The ΔPP validity criteria were recorded prospectively and defined as follows: (i) mechanical ventilation in the absence of spontaneous respiration; (ii) regular cardiac rhythm; (iii) tidal volume ≥8 ml kg(-1) of ideal body weight; (iv) a heart rate/respiratory rate ratio >3.6; (v) total respiratory system compliance ≥30 ml cm H2O(-1); and (vi) tricuspid annular peak systolic velocity ≥0.15 m s(-1). RESULTS: The study included 311 patients with a Simplified Acute Physiology Score II of 41 (39-43). Overall, only six (2%) patients satisfied all validity criteria. Of the 170 patients with an arterial line in place, only five (3%) satisfied the validity criteria. During the 24 h preceding the study time-point, fluid responsiveness was assessed for 79 patients. ΔPP had been used to assess fluid responsiveness in 15 of these cases (19%). CONCLUSIONS: A very low percentage of patients satisfied all criteria for valid use of ΔPP in the evaluation of fluid responsiveness. Physicians must consider limitations to the validity of ΔPP before using this variable.

[Early recurrent spontaneous abortion: How to take care in 2006?]. / Fausses couches spontanées précoces répétées: quelle prise en charge proposer en 2006?

More than 1% of the couples whishing children suffer from recurrent miscarriage, but investigations and treatment are not consensual. Most patients have several risk factors, and a minimum investigation of known factors has to be undertaken: karyotyping of the couple, hysteroscopy for searching uterine anatomic anomalies, evaluation for thrombophilias (anticardiolipin antibodies, lupus anticoagulant, protein C activity, Proteine S activity, factor V Leiden and factor II mutations, activated protein C resistance), antinuclear antibodies. Systemic diseases (like lupus) and endocrine abnormalities (like thyroid diseases and diabetes mellitus) have to be detected by clinical examination and questioning. No endocrine investigation is recommended, unless irregular menstruations or sterility. Research in recurrent pregnancy loss are conducted in new associated factors, such as skewed-X-chromosome inactivation, maternal HLA types, modifications in specific immune molecules and cells regulation. Therapeutic proposals are preimplantation genetic diagnosis in case of abnormal karyotiping, hysteroscopic surgery for septate uterus, aspirin plus heparin in antiphospholipid-positive patients, and aspirin plus corticosteroids in systemic lupus. Heparin seems to improve obstetrical prognosis for patients with congenital or acquired thrombophilias, but there are only few studies carried out on the subject. This new therapeutic approach should incite the patients with a negative medical appraisal to be referred to specialized consultations in order to include them in eventual clinical tests. Finally, empathic listening and psychological support are necessary in a pathology with multiple etiological factors.

[Acute pulmonary edema during preterm labor: role of nicardipine tocolysis (three cases)]. / OEdème pulmonaire aigu lors d'une menace d'accouchement prématuré: rôle de la tocolyse par la nicardipine: à propos de 3 observations.

Beta adrenergic agonists are still used as first line treatment for preterm labor in many institutions, but their side effects lead to use alternative tocolytic drugs such as calcium channel blockers. We report three cases of pulmonary edema during preterm labor associated with the use of calcium channel blocker, intravenous nicardipine, widely used for tocolysis in France. In this article, potential mechanisms of this severe complication are briefly discussed: pregnancy-induced overload, deleterious hemodynamic effects of calcium channel blockers, concomitant administration of calcium channel blockers and/or beta-agonists and finally concomitant administration of physiological saline and/or glucocorticoids. Based on our experience, we recommend avoiding the association of calcium channel blockers and beta-agonists for preterm labor. Nicardipine, if used, should be administered at an adjusted dose with electric syringe to reduce volume infusion.

[Operative termination of pregnancy between 12 and 14 weeks' gestation: influence of the operator's experience]. / Particularités techniques de l'IVG instrumentale entre 12 et 14 semaines d'aménorrhée: influence de l'expérience de l'opérateur.

OBJECTIVE: To assess the feasibility of operative termination of pregnancy between 12 and 14 weeks of gestation and the role of the operator's experience in physicians previously unfamiliar to this technique. MATERIALS AND METHODS: A prospective study of 251 operative terminations of pregnancy, from July 1st, 2001 to January 31st, 2002, and from May 1st, 2002 to October 31st, 2002, in order to assess the role of operator's experience. 104 terminations between 12 and 14 weeks were compared to 147 terminations at earlier gestational ages. All patients received cervical ripening with 400 mcg oral misoprostol 3-4 hours before operation performed under general anesthesia. Evaluation criteria were: duration of operation, need for use of forceps, and complications: uterine perforation, cervical laceration, bleeding > 500 ml and need for blood transfusion. RESULTS: There was no difference in the rate of operative complications between terminations before and after 12 weeks. The duration of operation was slightly longer after 12 weeks than before (12.9 +/- 6.7 min versus 11.1 +/- 2.8 min.; p < 0.05). Forceps use was 0.7% before 12 weeks, 20% between 12 and 13 weeks, and 59% between 13 and 14 weeks (p < 0.01). There was no difference in the complication rate or in the need for forceps according to the operator's experience. The perceived difficulty in cervical dilatation was higher in early experience than in experimented operators (19.6% versus 5.2%; p < 0.05). CONCLUSION: Operative termination of pregnancy is technically feasible beyond 12 weeks without dramatic increase in operative complications. Technical skill can be acquired in a short time interval.

[Surgical site infections after cesarean section: results of a five-year prospective surveillance]. / Infections de site opératoire chez les patientes césarisées: bilan de 5 années de surveillance.

AIMS: To determine the incidence of surgical site infections and to identify risk factors for infections. METHOD: A prospective study of surgical site infections (SSI) after cesarean section was carried out from September 1997 to September 1998 (pilot study) and from January 2000 to August 2003, using the methodology of the American National Nosocomial Infection Surveillance System. Follow up of women was performed by midwives until discharge and during the post-natal visit. Suspected surgical site infections were confirmed by surgeons and infection control practitioners. The microbiological file of each patient was edited 30 days after cesarean section. Risk factors were analyzed using a logistic regression model. RESULTS: During the pilot study, infection rate was estimated at 3.2%. At multivariate analysis, factors independently associated with an increased risk of SSI were ASA score > 1, performance of cesarean section in a room not dedicated to this activity, and use of an open urine drainage system. During the following years (2000-2003), infection rates progressively decreased to reach 1.9% in 2003. Infections included superficial wound infections (involving skin and subcutaneous tissue) (47%), deep wound infections (involving deep and soft tissue (fascia and muscle) (20%) and organ/space infections (i.e. endometritis, pelvic abscess) (33%). Infections occurred after patient discharge in 47.5% of cases and diagnosis was based only on clinical findings in 30% of cases. Infected patients were hospitalized longer (median: 6 days) than non infected patients. CONCLUSION: Prospective surveillance of SSI led to better awareness of infectious problems among health care workers, to identification of risk factors and evaluation of health procedures. Surveillance contributed to a decrease in nosocomial infections.

Antiphospholipid syndrome and second- or third-trimester fetal death: follow-up in the next pregnancy.

OBJECTIVE: To evaluate the efficacy of a uniform management protocol in antiphospholipid-antibody-positive obstetric patients with at least one second- or third-trimester intra-uterine fetal death. STUDY DESIGN: A prospective study of 33 successive pregnancies in antiphospholipid-antibody-positive patients, diagnosed after an intra-uterine fetal death. The management included treatment by a combination of aspirin and low-molecular-weight heparin, and a close follow-up with at least clinical examination, ultrasonography, uterine, and umbilical artery Doppler monthly from the first trimester. In the absence of any anomaly, delivery was induced between 37 and 38 weeks' gestation. RESULTS: In this high risk population, seven recurrences of vascular pathology occurred: five cases of mild, isolated fetal growth retardation and one of preeclampsia associated with fetal growth retardation requiring preterm delivery. Eight patients were delivered before 37 weeks. No recurrence of second- or third-trimester fetal death was observed. Uterine artery Doppler was informative as early as the first trimester (12-15 weeks): a bilateral notch was associated with a lower birthweight (2626+/-688 g versus 3178+/-353 g, respectively, p = 0.01), despite similar gestational age. The negative predictive value of uterine Doppler was more than 92% at 12-15 weeks' gestation and remained high throughout pregnancy. CONCLUSION: Although intra-uterine fetal death is considered at high risk of recurrence in case of antiphospholipid syndrome (APS), a uniform management protocol including aspirin and heparin and close obstetrical follow-up led to a favorable outcome in most cases.

[Treatment of recurrent spontaneous abortion associated with the antiphospholipid antibody syndrome]. / Modalités thérapeutiques d'une maladie abortive d'origine dysimmunitaire (syndrome des antiphospholipides primitif).

Treatment of repeated foetal loss associated with antiphospholipid syndrome was initially based on immunomodulating therapy such as corticosteroids or intravenous immunoglobulins. More recently aspirin and heparin have been assessed because of the thrombotic mechanisms involved in foetal losses. Randomized controlled trials have demonstrated that the association of aspirin and heparin is superior to aspirin alone in the prevention of recurrence of pregnancy loss.

Intravenous chemotherapy, early debulking surgery, and consolidation intraperitoneal chemotherapy in advanced ovarian carcinoma.

OBJECTIVE: The efficacy of a cisplatin-anthracycline combination, early debulking surgery, and intraperitoneal chemotherapy has been demonstrated through separate studies. We evaluated a multimodal treatment strategy integrating these therapeutic options. METHODS: Women with stage III or IV ovarian carcinoma received six cycles of cisplatin/epirubicin alternating with leucovorin and 5-fluorouracil. Patients with a residual disease (RD) measuring more than 2 cm after the initial laparotomy underwent an early debulking surgery after the first three cycles of chemotherapy. A second-look laparotomy (SLL) was performed after six cycles of intravenous chemotherapy. Intraperitoneal chemotherapy with cisplatin, VP16, and mitoxantrone was then administered in patients with no or RD < 2 cm after SLL. RESULTS: A total of 87 patients were included. After initial laparotomy, 11 patients (12%) had no macroscopic residual disease, 38 (44%) had a RD < or =2 cm, and 38 (44%) had a RD > 2 cm. After early debulking surgery, an additional 18 patients (21%) had a RD < 2 cm. Seventy-five patients were evaluable for response to intravenous chemotherapy: the overall response rate was 80%, and 30 patients achieved a pathological complete response (40%). Eight percent of the patients had stable disease and 12% had a progression. Sixty-eight patients received intraperitoneal chemotherapy after second-look laparotomy. With a 72-month median follow-up, median overall survival and progression-free survival were, respectively, 37 and 19 months. Five-year survival was 41%. CONCLUSION: The prognosis of patients with advanced ovarian carcinoma may be improved by a sequential treatment strategy including intravenous chemotherapy, early debulking surgery, and intraperitoneal chemotherapy.

[Which tocolytics should be used in 2001?]. / Quels tocolytiques utiliser en 2001?

Beta-mimetics are the gold standard tocolytic treatment but raise several problems. Despite their recognized efficacy in prolonging pregnancy, the neonatal benefit remains to be proven. There are several contraindications and frequent adverse effects, with a risk of fatal maternal accidents. The lack of reliable criteria for the prediction of preterm birth leads to giving unnecessary treatments to two-thirds of the patients. In this context, obstetrical practices have tended to prefer tocolytics which, with the same efficacy, would have fewer side effects than beta-mimetics and which would not raise a risk of severe complications. Calcium-channel blockers belonging to the dihydropyridin family and ocytocin antagonists would appear to meet the new requirements. In randomized trials versus beta-mimetics, they have been found to have a comparable effect in prolonging pregnancy by 48 hours. Tolerance is better than with beta-mimetics and treatment interruption due to side effects can be avoided. Finally, a meta-analysis of trials comparing calcium inhibitors versus beta-mimetics demonstrated a decrease in respiratory distress syndrome in the neonates and a reduction in the number of transfers to neonatal intensive care. The data accumulated on these new compounds would appear to suggest that they should be used as the first line treatment and not as an alternative to beta-mimetics. Other compounds including NO donors and cyclo-oxygenase 2 inhibitors are under evaluation.

Precarity and pregnancy in Paris.

OBJECTIVE: Our purpose was to assess to what extent the absence of health insurance (Social Security) contributes to poor pregnancy outcome. STUDY DESIGN: A prospective, population-based study compared the perinatal outcome of women without Social Security (n=243) to a contemporaneous control group (n=243) and to a group of women (n=32) with Social Security but presenting another risk factor for precarity (a judicial child-mother separation sentence). RESULTS: Prenatal consultations were less frequent and initiated later for women without Social Security than for controls. There was no difference between these two groups concerning maternal morbidity (premature labour, hypertension, gestational diabetes, post-partum complications) or maternal mortality, no difference for the mode of delivery and the rate of low birth-weight, foetal death, and neonatal morbidity (hypoglycaemia, hypocalcemia, anaemia, jaundice, infection and transfer to intensive care unit). The rate of prematurity was not significantly higher in the group without Social Security compared to the control group (11.1% versus 6.2%, P=0.08). However, in the group with Social Security and a court sentence of child mother separation, the rate of fetal growth retardation, prematurity, home delivery, caesarean section, neonatal drug deprivation syndrome and transfer to an intensive care unit was significantly higher compared to the two other groups (P<0.01). CONCLUSION: In our study, absence of Social Security during pregnancy is not a major determinant of poor pregnancy outcome, whereas other factors of precarity seem to be more influential.

[Indications for axillary node dissection in breast cancers]. / Indications du curage axillaire dans les cancers du sein.

Axillary lymph node dissection is in theory of both therapeutic and prognostic benefit for patients with breast cancer. For several authors, its therapeutic function, which consists in surgical dissection of potentially metastatic nodes, may be assured effectively by radiotherapy, but results of different comparative studies are contradictive. However, axillary dissection should be eliminated for small tumors (< 5 mm) because of the low yield of positive nodes (< 3%). Even if new histologic prognosticators are currently in evaluation, axillary node stagging is the single most important prognostic variable, and determines the indication for chemotherapy for premenopausal patients. Morbidity remains high, even if rarely severe, and new technologies are studied to try to locate the first node draining the tumor, in order to pick it out electively for histologic examination.

Female and male human embryo growth rates are similar before the eight-cell stage.

OBJECTIVE: Our purpose was to assess the possible relationship between human embryo growth rates and sexual differentiation. STUDY DESIGN: We analyzed 142 conceptional in vitro fertilization and embryo transfer cycles undertaken in 137 women (151 embryos transferred) in which each embryo transferred led to a gestational sac. Embryos were sorted into three groups according to the number of blastomeres assessed just before embryo transfers < or = 3, 4, and > or = 5 blastomeres. RESULTS: Percentages of girls and boys remained roughly unaltered irrespective of the number of blastomeres observed just before embryo transfer: < or = 3 blastomeres, 45% and 55%; 4 blastomeres, 44% and 56%; and > or = 5 blastomeres, 45% and 55%, respectively (statistical power 90% at the 5% significance level). CONCLUSIONS: This indicates that embryo growth rates before the eight-cell stage are not related to the sex of the live-born infant, thereby dissuading the use of embryo growth rates in the appraisal of sex likelihood in regular in vitro fertilization-embryo transfer.

Congenital adenomatoid disease of the lung: prenatal diagnosis and perinatal management

Prenatal ultrasonographic (US) detection of congenital adenomatoid malformation (CAM) was made in 18 fetuses at 17 - 36 weeks' gestation and managed in our institution during a 10-year period (1985-1994). The lesion was left-sided in 13 cases, right-sided in 4, and bilateral in 1. According to Stocker's classification, 12 cases were type I, 4 type II, and 2 type III. The prenatal course was followed with serial US examinations in 13 cases; the size of the lesion was stable in 8 and decreased in 5. Mediastinal shift was usually observed, and amniotic fluid volume was increased in 4 cases. One fetus was aborted. Six infants presented with respiratory distress syndrome and required neonatal surgery; delayed surgery was performed in 9 cases. Spontaneous regression of the lesion was observed on follow-up in 2 cases. Surgery consisted in lobectomy in 8 cases and segmentectomy in 6. The presence of fetal hydrops, type III lesions, and bilateral lung involvement are prenatal factors known to be associated with a poor prognosis. However, this series and a review of the literature suggest that caution should be observed with regard to the initial impression when counseling the parents regarding prognosis.

Congenital adenomatoid disease of the lung: prenatal diagnosis and perinatal management.

Prenatal ultrasonographic (US) detection of congenital adenomatoid malformation (CAM) was made in 18 fetuses at 17 - 36 weeks' gestation and managed in our institution during a 10-year period (1985-1994). The lesion was left-sided in 13 cases, right-sided in 4, and bilateral in 1. According to Stocker's classification, 12 cases were type I, 4 type II, and 2 type III. The prenatal course was followed with serial US examinations in 13 cases; the size of the lesion was stable in 8 and decreased in 5. Mediastinal shift was usually observed, and amniotic fluid volume was increased in 4 cases. One fetus was aborted. Six infants presented with respiratory distress syndrome and required neonatal surgery; delayed surgery was performed in 9 cases. Spontaneous regression of the lesion was observed on follow-up in 2 cases. Surgery consisted in lobectomy in 8 cases and segmentectomy in 6. The presence of fetal hydrops, type III lesions, and bilateral lung involvement are prenatal factors known to be associated with a poor prognosis. However, this series and a review of the literature suggest that caution should be observed with regard to the initial impression when counseling the parents regarding prognosis.