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      The safety of tocolytics used for the inhibition of preterm labour

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          Abstract

          Preterm birth is the major cause of neonatal mortality and morbidity worldwide and a huge cost burden on healthcare. Between 22 and 26 completed weeks of gestation, for every day that delivery is delayed, survival increases by 3%.

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          One-year survival of extremely preterm infants after active perinatal care in Sweden.

          Vineta Fellman, Lena Hellström-Westas, Mikael Norman … (2009)
          Up-to-date information on infant survival after extremely preterm birth is needed for assessing perinatal care services, clinical guidelines, and parental counseling. To determine the 1-year survival in all infants born before 27 gestational weeks in Sweden during 2004-2007. Population-based prospective observational study of extremely preterm infants (707 live-born and 304 stillbirths) born to 887 mothers in 904 deliveries (102 multiple births) in all obstetric and neonatal units in Sweden from April 1, 2004, to March 31, 2007. Infant survival to 365 days and survival without major neonatal morbidity (intraventricular hemorrhage grade >2, retinopathy of prematurity stage >2, periventricular leukomalacia, necrotizing enterocolitis, severe bronchopulmonary dysplasia). Associations between perinatal interventions and survival. The incidence of extreme prematurity was 3.3 per 1000 infants. Overall perinatal mortality was 45% (from 93% at 22 weeks to 24% at 26 weeks), with 30% stillbirths, including 6.5% intrapartum deaths. Of live-born infants, 91% were admitted to neonatal intensive care and 70% survived to 1 year of age (95% confidence interval [CI], 67%-73%). The Kaplan-Meier survival estimates for 22, 23, 24, 25, and 26 weeks were 9.8% (95% CI, 4%-23%), 53% (95% CI, 44%-63%), 67% (95% CI, 59%-75%), 82% (95% CI, 76%-87%), and 85% (95% CI, 81%-90%), respectively. Lower risk of infant death was associated with tocolytic treatment (adjusted for gestational age odds ratio [OR], 0.43; 95% CI, 0.36-0.52), antenatal corticosteroids (OR, 0.44; 95% CI, 0.24-0.81), surfactant treatment within 2 hours after birth (OR, 0.47; 95% CI, 0.32-0.71), and birth at a level III hospital (OR, 0.49; 95% CI, 0.32-0.75). Among 1-year survivors, 45% had no major neonatal morbidity. During 2004 to 2007, 1-year survival of infants born alive at 22 to 26 weeks of gestation in Sweden was 70% and ranged from 9.8% at 22 weeks to 85% at 26 weeks.
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            The EPICure Study: Outcomes to Discharge From Hospital for Infants Born at the Threshold of Viability

            K Costeloe, E. Hennessy, A Gibson … (2000)
            To evaluate the outcome for all infants born before 26 weeks of gestation in the United Kingdom and the Republic of Ireland. This report is of survival and complications up until discharge from hospital.
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              An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue.

              J. Smith, J Veille, K. Allison Perry … (2000)
              This study was designed to evaluate the efficacy and safety of the oxytocin receptor antagonist atosiban in the treatment of preterm labor. A multicenter, double-blind, placebo-controlled trial with tocolytic rescue was designed. Five hundred thirty-one patients were randomized to receive, and 501 received, either intravenous atosiban (n = 246) or placebo (n = 255), followed by subcutaneous maintenance with the assigned agent. Standard tocolytics as rescue tocolysis were permitted after 1 hour of either placebo or atosiban if preterm labor continued. The primary end point was the time from the start of study drug to delivery or therapeutic failure. Secondary end points were the proportion of patients who remained undelivered and did not receive an alternate tocolytic at 24 hours, 48 hours, and 7 days. No significant difference was found in the time from start of treatment to delivery or therapeutic failure between atosiban and placebo (median, 25.6 days vs 21.0 days, respectively; P =.6). The percentages of patients remaining undelivered and not requiring an alternate tocolytic at 24 hours, 48 hours, and 7 days were significantly higher in the atosiban group than in the control group (all P or =28 weeks. Fourteen atosiban-treated patients and 5 placebo-treated patients were randomized at or =28 weeks, and this occurred with a low rate of maternal-fetal adverse effects. In addition, at a gestational age > or =28 weeks, the infant morbidity and mortality of atosiban-initiated standard care were similar to those with placebo-initiated standard care. Given that all patients in this study were eligible for tocolysis and that, in practice, nearly all patients who are eligible for a tocolytic receive one, the benefit of using atosiban is the placebo-like maternal-fetal side effect profile. These observations support the use of this oxytocin receptor antagonist in the treatment of patients in preterm labor with intact membranes. Efficacy and infant outcome data at <28 weeks are inconclusive.
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                Author and article information

                Journal
                Title: Expert Opinion on Drug Safety
                Abbreviated Title: Expert Opinion on Drug Safety
                Publisher: Informa UK Limited
                ISSN (Print): 1474-0338
                ISSN (Electronic): 1744-764X
                Publication date Created: September 01 2016
                Publication date (Electronic): June 03 2016
                Publication date (Print): September 01 2016
                Volume: 15
                Issue: 9
                Pages: 1163-1173
                Affiliations
                [1 ]Department of Medical Education, Lincoln County Hospital, Lincoln, UK
                [2 ]Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark
                [3 ]Institute of Clinical Research, Research Unit of Gynaecology and Obstetrics, University of Southern Denmark, Odense, Denmark
                [4 ]Centre for Innovative Medical Technology, Odense University Hospital, Odense, Denmark
                [5 ]Division of Surgery, University College London, Northwick Park Institute for Medical Research Campus, London, UK
                Article
                DOI: 10.1080/14740338.2016.1187128
                PubMed ID: 27159501
                SO-VID: 34a7cb04-4b1f-4684-8755-7bac9fb79d39
                Copyright © © 2016
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