Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol.

BACKGROUND: Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. METHODS/DESIGN: This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate). TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). Identifier: ACTRN12613000141741.

Utilization of carbetocin for prevention of postpartum hemorrhage after cesarean section: a randomized clinical trial.

PURPOSE: A randomized study involving pregnant women was conducted to compare the effectiveness of a single intravenous (IV) injection of carbetocin with that of a standard 2-h oxytocin IV infusion with respect to intraoperative blood loss in the prevention of uterine atony after cesarean section (CS). The two treatments also were compared for safety and ability to maintain adequate uterine tone and to reduce the incidence and severity of postpartum hemorrhage (PPH) in women at risk for this condition. METHODS: Between 1 September 2007 and 5 January 2008, we enrolled 104 patients with at least one risk factor for PPH undergoing CS in a randomized, controlled clinical trial. We compared the effect of a single 100 microg IV dose of carbetocin with that of a standard 2-h ten international units (IU) IV infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. Fiftytwo women received 100 microg carbetocin IV immediately after placental delivery, while 52 women received 10 IU oxytocin IV infusion. Complete blood count was collected at entry and 24 h postpartum. All outcome measures, including the need for additional uterotonic agents or uterine massage, and blood loss, were analyzed using chi-square, Fisher exact, and Student's t tests. RESULTS: A single 100 microg IV injection of carbetocin was as effective as a continuous 2-h infusion of oxytocin in controlling intraoperative blood loss after placental delivery. Mean blood loss after carbetocin administration was 30 ml less than after oxytocin administration (P = 0.5). The percentage of patients with blood loss < or =500 ml was greater with carbetocin (81 vs. 55%; P = 0.05). Carbetocin enhanced early postpartum uterine involution. The fundus was below the umbilicus in more patients who received carbetocin at 0, 2, 6, and 24 h on the ward (P < 0.05). The main additional uterotonic agent used was a further administration of oxytocin (20 IU in physiological solution 500 ml at an infusion rate of 200 ml/h). In the carbetocin group, 20 of the 52 women (38.4%) required at least one uterine massage compared to 30 of the 52 women (57.7%) in the oxytocin group (P < 0.01). Overall, uterotonic intervention was clinically indicated in two of the women (3.8%) receiving carbetocin compared to five of the women (9.6%) given an IV oxytocin infusion (P < 0.01). The odds ratio of treatment failure requiring oxytocic intervention was 1.83 (95% confidence interval, CI, 0.9-2.6) times higher in the oxytocin group compared with the carbetocin group. CONCLUSIONS: Carbetocin makes possible to obtain, with a single IV injection, results equivalent to those of oxytocin on the maintenance of uterine tonicity and the limitation of blood losses, in the peri- and in the post-operative period, during a delivery by CS. It has in addition a comparable tolerance. Even in our series adverse events are practically of the same type and similar frequency in both study groups. Thus, the effectiveness of carbetocin consists, thanks to its long half-life, on an unique injection, whereas oxytocin requires repeated injections or a perfusion of several hours, with a variability of the administered doses.

Pregnancy and post-partum breast cancer: a prospective study.

BACKGROUND: The concomitant occurrence of breast cancer and pregnancy remains a challenging clinical situation combining ethical and medical problems. There are few prospective data on pregnancy-associated breast cancer (PABC) whose incidence continuously increases. PATIENTS AND METHODS: Forty patients with PABC were compared with 61 non-pregnant, age-matched patients with infiltrative breast carcinomas (BC) diagnosed and followed since 1982. RESULTS: Although PABC and BC tumor size, grade and type, and lymphovascular and lymphnode invasion were similar, the BC cases showed better overall--(p=0.0001) and disease-free (p-0.015) survival. Moreover, the outcome of pregnant patients was worse than post-partum patients (p=0.017). Importantly, the number of PABC patients receiving hormonotherapy was lower than the BC patients (p<0.0004), due to lower estrogen receptor (ER) (p=0.038) and progesterone receptor (PR) (p=0.008) immunohisto-chemical (IH) levels. Retrospective estrogen-regulated pS2/trefoil factor 1 (pS2/TFF1) immunohistochemitry showed no difference between PABC and BC. All the children delivered were healthy. CONCLUSION: Pregnancy and the post-partum period increase breast cancer aggressiveness, pregnancy being the most detrimental. PABC hormone-dependence is under-estimated using ER and PR, and pS2/TFF1 might help in its determination. Appropriate treatment does not impair child outcome.

Prevention of cerebral palsy during labour: role of foetal lactate.

OBJECTIVES: Intrapartum foetal monitoring goal is to prevent foetal asphyxia and its most severe consequence: cerebral palsy (CP). In this paper we describe the detection methods and the criteria needed to assess asphyxia during labour for preventing CP. Foetal cerebral damage assessment is considered from the medical-legal point of view. CP represents the most frequent pathology of childhood related to pregnancy and childbirth with an incidence of 0.2% in children born alive. It is clinically regarded as the result of a spectrum of diseases due to damage or to faded development of the nervous system which generally appears at the time of the first stage of intra-uterine growth or depends on problems arising at birth. The goal of our analysis is to recall the various moments in which this event can take place and, if possible, the moment and the degree of the event of asphyxia and its effect on foetal conditions, in order to control and treat it. STUDY DESIGN: One hundred and eighty-eight fetuses were evaluated by means of Apgar score, intrapartum cardiotocography, observation of the presence of meconium stained amniotic fluid, and clinical features of distress at birth. Lactate concentrations were measured during labour and at delivery in blood samples obtained from the foetal presenting part (foetal scalp) and from the umbilical cord with the use of a rapid electrochemical technique. RESULTS: Evidence of clinical foetal distress was not related to the severity of 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 (P = 0.49, 0.01), but with neither Apgar score at 1 min (R = -0.21, ns) nor at 5 min (R = -0.11, ns). Lactate concentration was higher in case of instrumental delivery compared to spontaneous delivery (P = 0.0001). 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 instrumental delivery in the distress group was significantly higher than in that of the healthy fetuses (P < 0.01), so spontaneous labour was less frequently associated with foetal distress than instrumental delivery (P < 0.01). In the distress group, severe variable decelerations were generally recorded in the second stage of labour. The incidence of neonatal Apgar score /=45 min, compared with a shorter active second stage, and acidaemia at birth implied larger arterial-venous lactate differences (P < 0.001). The presence of foetal lactate at crowning was also significantly associated with the level of umbilical arterial-venous lactate difference (P = 0.03). CONCLUSIONS: Analysis of the fetus should start with the assessment of lactates and acid-base balance. The method which revolutionized the techniques of foetal monitoring is undoubtedly represented by cardiotocography. However, likely most of neurological outcomes are not correlated with a perinatal event or with peripartum asphyxia. Approximately 10% of cases of CP would actually be due to perinatal asphyxia, and this percentage approaches approximately to 15% if we consider only newborns at term. This again confirms the weak association of a causal relationship between asphyxia and CP. In addition, available foetal suffering markers are vague and allow to identify only less than half of the effective cases of newborns which will develop CP.

The complex relationship between smoking in pregnancy and very preterm delivery. Results of the Epipage study.

OBJECTIVE: To assess the relationship between cigarette smoking during pregnancy and very preterm births, according to the main mechanisms of preterm birth. DESIGN: Case-control study (the French Epipage study). SETTING: Regionally defined population of births in France. POPULATION: Eight hundred and sixty-four very preterm live-born singletons (between 27 and 32 completed weeks of gestation) and 567 unmatched full-term controls. METHODS: Data from the French Epipage study were analysed using a polytomous logistic regression model to control for social and demographic characteristics, pre-pregnancy body mass index and obstetric history. The main mechanisms of preterm delivery were classified as gestational hypertension, antepartum haemorrhage, premature rupture of membranes, spontaneous preterm labour and other miscellaneous mechanisms. MAIN OUTCOME MEASURES: Odds ratios for very preterm birth for low to moderate (1-9 cigarettes/day) and heavy (>/=10 cigarettes/day) maternal smoking in pregnancy, estimated according to the main mechanisms leading to preterm birth. RESULTS: Smokers were more likely to give birth to very preterm infants than non-smokers [adjusted odds ratio (aOR) 1.7, 95% confidence interval (CI) 1.3-2.2]. Heavy smoking significantly reduced the risk of very preterm birth due to gestational hypertension (aOR 0.5, 95% CI 0.3-1.0), whereas both low to moderate and heavy smoking increased the risk of very preterm birth due to all other mechanisms (aOR between 1.6 and 2.8). CONCLUSION: These data from the Epipage study show that maternal smoking during pregnancy is a risk factor for very preterm birth. The impact of maternal smoking on very preterm birth appears to be complex: it lowers the risk of very preterm birth due to gestational hypertension, but increases the risk of very preterm birth due to other mechanisms. These findings might explain why maternal smoking is more closely related to preterm birth among multiparous women than among nulliparous women.