[Off-label drug use of the misoprostol in gynecology & obstetrics: From a medico-economics benefit to a potential legal risk]. / La prescription hors AMM en gynécologie-obstétrique : du pragmatisme médico-économique au potentiel risque médico-légal.

The scandal of the Mediator® case led the legislature to take measures in order to regulate off-label drugs prescriptions. Indeed the law issued in December 29th, 2011 on strengthening the safety of drugs and all derivative health products came to pave the way for an "over-cautious" practice of medicine in line with the precautionary principle erected as a constitutional principle. The supervision of off-label prescribing has had a direct impact on the exercise of the medical profession and has resurrected the issues related to the freedom of prescription, the obligation to provide information to patients and in general their whole responsibility. It is important to mention that the prescribing act is part of the freedom and the strict prerogative of those skilled in the art: the physician in this case. The off-label prescription is commonly accepted in certain specialties, such as anesthesia and intensive care, oncology or pediatrics where it is even subject of a memorandum of use because of concerns regarding the availability of forms adapted to children. However, the physician must ensure that no appropriate therapeutic alternative is available and inform the patient, fundamental principle of the right to respect for the will of the person. Off-label use of the prostaglandin-E1 analogue misoprostol in obstetrics and gynecology is a good example. In fact, this drug obtained a marketing authorization for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label when inducing labour or intrauterine device insertion. These are the issues that need to be clarify and carefully assessed in order to help physicians to understand the impact of the law and the state of the jurisprudence on the exercise of their profession.

[Peritoneal serous borderline tumor discovered during a cesarean section. A case report]. / Tumeur séreuse borderline péritonéale découverte lors d'une césarienne. A propos d'un cas.

During a caesarean section performed in a 36-year-old woman, we discovered small granulations on the pelvic peritoneum. Biopsies were performed. The diagnosis of primitive borderline serous tumor was confirmed by pathologists. The patient was operated twice: once for diagnostic evaluation, and again six months later. A radical gesture was then decided for therapeutic purposes. The optimal attitude regarding these borderline peritoneal tumors in young women remains difficult and requires a multidisciplinary workout between pathologists and surgeons.

[Management of ovarian cysts]. / Prise en charge des kystes ovariens.

Ovarian cysts occur frequently in women of reproductive age. These are usually functional cysts which resolve spontaneously and whose evolution can be followed with ultrasound. Non-functional cysts have diverse histologic origins. The most common are serous and mucinous cystadenomas which arise from the epithelial wall of the ovary, endometriomas which arise in the setting of pelvic endometriosis, and dermoid cysts which arise from the germinal cells of the ovary. Endovaginal ultrasound with Doppler enhancement is the best imaging technique to establish the nature of cysts and to distinguish cysts suspicious for malignancy which require more invasive investigation. Pelvic laparoscopy is the surgical approach of choice for the treatment of non-functional benign ovarian cysts. Conservative treatment to shell out the cyst and preserve functional ovarian tissue should be reserved for women desirous of future pregnancies. The risk of ovarian cancer remains a major preoccupation of the surgeon. Where malignancy is suspected, laparoscopy is contraindicated and a median laparotomy is appropriate for radical extirpative surgery. This article describes the diagnostic techniques which allow a laparoscopic approach to presumably benign cysts and discusses surgical techniques specifically adapted to their different histologic nature of ovarian cysts.

Screening of foetal distress by assessment of umbilical cord lactate.

PURPOSE OF INVESTIGATION: Studies on umbilical cord blood for determination of lactate indicate that high levels seem to be correlated to foetal metabolism for anaerobic glycolysis taking place in oxygen-deprived tissues of the foetus. These findings may be of particular-deprived clinical importance when foetal distress or foetal hypoxemia is caused by perinatal events. METHODS: The maternal and foetal heart rates, acid-base values measured and the outcome of 94 pregnancies complicated by intrapartum foetal asphyxia have been reviewed, and the maternal and foetal acid-base and lactate levels during the course of labour and at delivery were studied in patients with evidence of metabolic acidosis. Lactate concentrations were measured during labour and at delivery in blood samples obtained from the foetal presenting part and from the umbilical cord with the use of a rapid electrochemical technique. The foetuses were evaluated by means of the Apgar score, intrapartum cardiotocography, observation of the presence of meconium stained amniotic fluid, and clinical features of distress at birth. RESULTS: Evidence of clinical foetal distress was not related to the severity of the asphyxia. An increased lactate level was found in asphyctic infants and a clear correlation between lactic acidosis and foetal distress was documented. Low Apgar scores were observed in infants with moderate or severe asphyxia at delivery. Scalp lactate correlated significantly with umbilical artery lactate, but not with 1-min or 5-min Apgar scores. The lactate concentration was higher in cases of instrumental delivery compared to spontaneous delivery. No perfect correlation was found between lactate level and neonatal outcome but there were not a significant number of neonates with immediate complications. The rate of forceps delivery in the distress group was significantly higher than that of the healthy foetuses, so spontaneous labour was less frequently associated with foetal distress than instrumental delivery. In the distress group, severe variable decelerations were generally recorded in the second stage of labour. The incidence of neonatal Apgar score < or = 7 in neonates with abnormal baseline foetal heart rate (FHR) was higher than in those with severe variable decelerations, mild variable decelerations, and transient tachycardia. Duration of the active second stage of labour was significantly with the presence of foetal lactate at the time of crowning of the foetal head and the presence of lactate in umbilical arterial and vein blood at delivery. Expulsion time > or = 45 minutes, compared with shorter active second stage, and acidaemia at birth implied larger arterial-venous lactate differences. The presence of foetal lactate at crowning was also significantly associated with the level of umbilical arterial-venous lactate difference. CONCLUSION: Lactate and pH values provide the best parameters to distinguish between asphyctic and normal newborns, with lactate having the most discriminating power. The prospective value of the discrimination functions derived from lactate and pH data is good when the foetuses are allocated into normal parameters but poor when an attempt is made to allocate the foetuses into pathologic ones, with a high false-negative rate. However, the discriminating ability is improved when pathologic foetuses are included into one single abnormal group. These results confirm the potential use of rapid foetal blood lactate measurements for the early diagnosis of intrapartum foetal distress.

[Femoral neuropathy after transversal suspubic laparotomies. Etiopathological explanation on the basis of an anatomical study]. / Paralysie du nerf fémoral dans les suites des laparotomies transversales sus-pubiennes: étude anatomique et hypothèses étiopathogéniques.

OBJECTIVES: Based on a case of transient troncular femoral neuropathy after the surgical treatment of a genital prolapse in a 46-year-old woman, a study was designed to better understand the mechanism of this postoperative complication. METHODS: The consequences of different varieties of transversal laparotomies were investigated in human cadavers. RESULTS: On the basis of the data from the anatomical evaluation, the most probable etiopathogenic explanation for the complication we observed is the compression of the femoral nerve, inside the psoas muscle, by the retractor lower edge. CONCLUSION: In the reported case, the outcome was simple with full sensory and motor recovery in the lower limb. The different mechanisms potentially involved in this kind of postoperative femoral neuropathies are reviewed and discussed.

[Multidisciplinary management of aortic dissection complicating pregnancy]. / Prise en charge multidisciplinaire d'une grossesse compliquée de dissection aortique.

BACKGROUND: Most cases of aortic dissection observed in women under 40 years of age occur as a complication of pregnancy in patients with other risk factors. Case report. We report a case of dissection of the ascending aorta in a young primigravida at 35 weeks gestation. The risk factor was aortic regurgitation. Multidisciplinary management enabled fetal extraction followed by repair of the aorta. Outcome was favorable for both mother and child. DISCUSSION: A review of the literature shows a variety of etiological factors leading to this disease. Emergency diagnosis and management is mandatory. Obstetricians should be aware that pregnancy can be a triggering factor in patients with a predisposition, e.g. connective tissue disease. A complete cardiovascular evaluation should be conducted before conception and a suitable surveillance planned for the entire pregnancy. The aim of this careful follow-up it to avoid surgery in an emergency setting that could compromise prognosis for both mother and child.

Antiphospholipid antibodies and preeclampsia: a case-control study.

OBJECTIVE: To assess the association between the occurrence first of preeclampsia and antiphospholipid antibodies. METHODS: We conducted a prospective case-control study of 180 pregnant women with their first incidents of preeclampsia and no histories of thrombosis or systemic autoimmune diseases. Preeclampsia (n = 180) was defined as blood pressure (BP) at least 140/90 mmHg after 20 weeks' gestation and proteinuria at least 0.3 g per 24 hours. Two control subjects were matched to each case (n = 360). They were pregnant women without hypertension or proteinuria and without histories of thrombosis or systemic autoimmune disease. Lupus anticoagulant (activated partial thromboplastin time, diluted thromboplastin time, platelet neutralization procedure) and anticardiolipin antibodies (immunoenzymatic assays) were assessed in both groups, and the coagulation state (levels of thrombin-antithrombin III complexes, fragments 1 + 2 of prothrombin) was also evaluated. The analysis design was a sequential plan with 5% type I error and 95% power. RESULTS: There was no association between antiphospholipid antibodies and preeclampsia. The odds ratio for the association was 0.95 (95% confidence interval 0.45, 2.61). Antiphospholipid antibodies were detected in eight of 180 preeclamptic women and in 19 of 360 controls. In contrast, there was a clear, confirmed activation of coagulation during preeclampsia. CONCLUSION: Despite evidence of a prothrombotic state during preeclampsia, it is unlikely that antiphospholipid antibodies (lupus anticoagulant and anticardiolipin antibodies) represent risk factors for preeclampsia among women with no previous preeclampsia and no histories of thrombosis or systemic autoimmune disease.

[Massive feto-maternal transfusion. Report of 3 cases with review of the literature]. / La macrotransfusion foeto-maternelle. A propos de 3 cas avec revue de la littérature.

Massive feto maternal hemorrhage is rare. Early diagnosis is important because massive feto-maternal hemorrhage has a poor prognosis. The clinical manifestations of transplacental hemorrhage are related not only to the size of the hemorrhage but also to the time at which the hemorrhage occurs. In women who are candidates for Rh immune prophylaxis, massive feto maternal hemorrhage may be detected by Kleihauer test and we suggest that 10 micrograms dose of immune globin should be administered for each estimated ml of Rh positive blood given, to prevent an immunization Disappearance of fetal cells by Kleihauer test or appearance residual antibody suggests the adequacy of therapy. Three cases of massive fetomaternal hemorrhage (more than 225 ml) are presented here. Two mothers was Rh negative and they are delivered of rhésus positive children, which necessitated the administration of large volume of anti D. One of the cases shows the possibility of association between choriocarcinoma and positive kleihauer test.

[Ursodeoxycholic acid: prospect for treatment of gravidic cholestasis? Report of 3 cases]. / L'acide ursodésoxycholique: perspective de traitement de la cholestase gravidique? A propos de 3 observations.

Ursodeoxycholic acid, employed in treatment of intrahepatic cholestasis as seen in primary biliary cirrhosis, primary sclerosing cholangitis, and chronic hepatitis; does not have marketing approval for prescription during pregnancy because of lack of data. In 3 cases of gravidic cholestasis, we administered oral ursodeoxycholic acid 1 g a day from the 34th week of amenorrhea to delivery. In each case, it took 3 days of treatment for the pruritus to regress incompletely and for plasma levels of biliary acid and transaminases to decrease. The infants, born between the 36th and 38th week of amenorrhea, presented with no problem. Forty-eight cases of gravidic cholestasis treated by ursodeoxocholic acid (0.4 to 1 g a day) have been reported in the literature; 18 cases belonging to 2 randomized studies. In 46 cases pruritus disappeared generally 3 days after treatment onset, and plasma level of biliary acid and transaminase decreased in one week. Only two patients experienced persisting pruritus despite biological improvement. No foetal adverse effect is reported. Ursodeoxycholic acid seems to be an efficient treatment of gravidic cholestasis. Long term observation of fetuses exposed in utero to this treatment is required to assess safety.

A family with dominant oculoauriculovertebral spectrum.

In 1990, Gorlin et al. [Syndromes of the Head and Neck, New York: Oxford University Press, pp 641-649, 707-708] proposed to lump several syndromes together, including facioauriculovertebral syndrome, hemifacial microsomia, otomandibular dysostosis, Goldenhar syndrome, the first branchial arch anomalies and the first and second branchial arches anomalies. They proposed to use the term oculoauriculovertebral "spectrum." Because there is no agreement on minimal diagnostic criteria the phenotype overlaps many genetic and teratologic syndromes. Most cases are sporadic, but familial instances have also been observed in first-degree relatives. We report on a mother and two of her children who have the oculoauriculovertebral "spectrum." The mother had only auricular anomalies for which she had plastic and reconstructive surgery. Her first child, a girl, had a bilateral cleft lip and palate, a coloboma of upper eyelid, facial asymmetry, and posteriorly angulated ears. This child also had bilateral vesicoureteral reflux. During the second pregnancy fetal ultrasonographic examination performed at 18th week of gestation showed a cleft lip and palate. At the thirty-first week of gestation, club feet, hypoplasia of the left ear, hypoplasia of the left maxillary and mandibular arches, and left microphthalmia were evident. Examination of this fetus confirmed ultrasonographic findings and demonstrated vertebral anomalies. This familial observation confirmed variable expressivity of the oculoauriculovertebral anomaly with isolated microtia (the mother), major malformations (the fetus), and less serious anomalies (the first child) and showed that this condition may be inherited as an autosomal or X-linked dominant condition.

[Bilateral subdural hematoma following epidural anesthesia]. / Hématome sous dural bilatéral après analgesie péridurale.

PURPOSE: The authors report a case of bilateral subdural hematoma (SDH) which occurred following epidural analgesia for labour, complicated by post dural puncture headache (PDPH). Physiopathological mechanisms are discussed. CLINICAL FEATURES: A 27-yr-old woman displayed typical PDPH following epidural anaesthesia. On the fifth day she was given a blood patch (BP) which proved immediately effective. Further developments were marked by late recurrence of PDPH and by administration of a second BP on the 24th day. With the aggravation of the headaches, the disappearance of their postural nature and with the appearance of transitory focal neurological signs on the 30th day, a CT-Scan was done and showed bilateral subdural haematoma. Following surgical drainage, the patient made an uneventful recovery. CONCLUSION: The presence of PDPH complicated by a typical neurological deterioration should prompt the anaesthetist to seek an immediate clinical and x-ray diagnosis in order to look for the existence of intracranial complications.

Prenatal diagnosis of Walker-Warburg syndrome in three sibs.

Walker-Warburg syndrome (WWS) is an autosomal recessive condition characterized by diffuse neurodysplasia, resulting in brain and eye abnormalities. We report on 3 prenatally diagnosed cases of this syndrome born to a consanguineous couple. An ultrasonographic examination showed hydrocephalus at the 27th week of the first pregnancy. Amniocentesis documented a normal male karyotype. The couple opted for termination of the pregnancy but declined an autopsy. Seven months later, hydrocephalus was observed at 20 weeks of the second pregnancy. Termination of pregnancy was performed at the 22nd week. Autopsy of this male fetus showed dilated ventricles, thin cortex, and type II lissencephaly with microscopic evidence of chaotic architecture. Eye examination showed retinal dysplasia. Notwithstanding the lack of demonstrable muscle change, the diagnosis of Walker-Warburg syndrome was made. Ten months later, hydrocephalus was discovered in the third fetus, a female, at 13 weeks of gestation. Termination of pregnancy was performed at 20 weeks. At autopsy, brain, eye, and muscular findings were similar to those of the previous case. In addition, cystic changes and a stenosis of the pyelo-ureteral junction were found in the right kidney. Type II lissencephaly and retinal dysplasia are characteristic of WWS. Muscular dystrophy has been pointed out as an additional abnormality in postnatal cases. By contrast, the lack of demonstrable muscle changes in the fetal period must be emphasized. Those cases illustrate practical problems in the ultrasound and pathologic diagnosis of WWS in the fetal period.

[Urinary complications during laparoscopy: a urachal diverticula injury]. / Complications urinaires de la coelioscopie: à propos d'une plaie d'un diverticule ouraquien.

The authors report a bladder injury during laparoscopic procedure. A laparotomy is performed immediately and shows an urachal anomaly with the bladder reaching the umbilic. One of the accessory trocars perforates the bladder in its unusual position. Surgical repair is made and the patient discharged without sequelae 12 days later. Rate of bladder injury increases with development of advanced laparoscopy as Burch and hysterectomy. Careful drainage with folley catheter during all laparoscopic procedures present greater than morbidity. Previous laparotomy may change the usual position of the bladder. Care must be taken in case of wall anomalies as in our observation. Per-operative suspicion of bladder injury (hematuria, presence of gas in the urinary catheter collection bag) can be proved with the injection of methylene blue in the folley catheter. Laparoscopic repair is possible for an experienced surgeon, associated with 10 days continuous urinary drainage and quinolone antibiotherapy. Morbidity of unknown bladder injury is great with some death-case reports. All diagnosis technique possible must be used to light these clinical situations, urinary peritonitis symptomatology is often non specific.

[Meckel syndrome. Update on a recurrent case]. / Le syndrome de Meckel. Mise au point a propos d'un cas récidivant.

Meckel's syndrome is an autosomal recessive disorder classically defined by occipital encephalocele, multicystic kidneys and polydactyly. However, a very wide phenotypic spectrum is characteristic of Meckel's syndrome. The prenatal diagnosis of this lethal syndrome is approached with ultrasound examination. The karyotype has to be done in order to make the differential diagnosis, especially with Trisomy 13 or 18. The rate of the Meckel's syndrome's gene is 1/400. The isolation of the specific gene will be soon helpful to define the Meckel's syndrome precisely.