Treatment of preterm labor with the oxytocin antagonist atosiban: a double-bind, randomized, controlled comparison with salbutamol

Objective: To compare the efficacy and safety of atosiban and salbutamol in the treatment of preterm labor. Study design: A multicenter, double-blind, double-placebo, randomized, controlled trial. Women (n=241) diagnosed with preterm labor at 23–33 gestational weeks were enrolled and received either atosiban (n=119) or salbutamol (n=122). At randomization, women were stratified by gestational age (≤28 weeks and >28 weeks). Atosiban (i.v. bolus dose of 6.75 mg, then 300 μg/min for 3 h and 100 μg/min for up to 48 h) and salbutamol (2.5–45 μg/min) were administered by i.v. infusion for up to 48 h. Retreatment with study drug or an alternative tocolytic agent was allowed. Main outcome measures included tocolytic effectiveness which was assessed in terms of the number of women undelivered after 48 h and 7 days. Tocolytic efficacy and tolerability were assessed in terms of the proportion of women undelivered and who did not require alternative tocolytic therapy at 48 h and 7 days of starting treatment. Safety was assessed in terms of maternal side effects and neonatal morbidity. Results: Tocolytic effectiveness at 48 h was 93.3 versus 95.0% (P=0.67) and after 7 days was 89.9 versus 90.1% (P=0.93) in the atosiban and salbutamol groups, respectively. Tocolytic efficacy and tolerability within 48 h was 79.8 versus 75.2% (P=0.15), and after 7 days was 58.8 versus 46.3% (P=0.021) in the atosiban and salbutamol groups, respectively. Maternal adverse events, including serious events, occurred more frequently in the salbutamol group. Neonatal outcomes were comparable between the study groups. Conclusions: The oxytocin antagonist atosiban was found to be better tolerated by both mother and fetus than salbutamol, with a comparable neonatal and infant safety profile, and atosiban was as effective as salbutamol in delaying threatened preterm birth. This study supports the clinical use of atosiban in the treatment of preterm labor.French/Australian Atosiban Investigators Grou

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).Fil: Schvartzman, Javier A.. Centro de Educaciones Médicas e Investigación Clínica "Norberto Quirno"; ArgentinaFil: Krupitzki, Hugo Bernardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Betran, Ana Pilar. Department of Reproductive Health and Research. Ginebra; SuizaFil: Requejo, Jennifer. Department of Reproductive Health and Research. Ginebra; SuizaFil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Gadow, Enrique Curt. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Vizcaino, Francisco M.. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Von Petery, Felicitas. Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno”; ArgentinaFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Belizan, Jose. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Borruto, Franco. Centre Hospitalier Princesse Grace; MónacoFil: Boulvain, Michel. Hopitaux Universitaires de Ginebra. Ginebra; SuizaFil: Di Renzo, Gian Carlo. Santa Maria Della Misericordia University Hospital; ItaliaFil: Gülmezoglu , Metin. World Health Organization. Ginebra; SuizaFil: Hofmeyr, Justus. University of the Witwatersrand; SudáfricaFil: Judge, Kevin. Becton Dr. Franklin Lakes. New York; Estados UnidosFil: Leung, Tak Yeung. The Chinese University of Hong Kong; Hong KongFil: Nguyen, My Huong. Department of Reproductive Health and Research. Ginebra; SuizaFil: Saugstad, Ola Didrik. University of Oslo; NoruegaFil: Temmerman, Marleen. Department of Reproductive Health and Research. Ginebra; SuizaFil: Treisser, Alain. Centre Hospitalier Princesse Grace; MónacoFil: Vayena, Effy. Universitat Zurich; SuizaFil: Merialdi, Mario. Department of Reproductive Health and Research. Ginebra; Suiz

Effect of Intra- and Extrauterine Growth on Long-Term Neurologic Outcomes of Very Preterm Infants

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