Blog
About

1
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2—a study protocol

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Introduction

          The STOPPIT-2 study aims to determine the clinical utility of the Arabin cervical pessary in preventing preterm birth in women with a twin pregnancy and a short cervix, about which there is current uncertainty. STOPPIT-2 will resolve uncertainty around effectiveness for women with a twin pregnancy and a cervical length of 35 mm or less, define adverse effects, ascertain acceptability and estimate National Health Service costs and savings.

          Methods

          STOPPIT-2 is a pragmatic multicentre open-label randomised controlled trial. Consenting women with twin pregnancy will have an transvaginal ultrasound scan of their cervical length performed between 18+0 and 20+6 weeks’ gestation by an accredited practitioner: women with a cervical length of ≤35 mm will be eligible for inclusion in the treatment phase of the study. The intervention by the insertion of the Arabin cervical pessary will be compared with standard treatment (no pessary).

          The primary outcomes are (obstetric) spontaneous onset of labour for the mother leading to delivery before 34 weeks’ gestation and (neonatal) a composite of specific adverse outcomes or death occurring up to the end of the first 4 weeks after the estimated date of delivery to either or both babies.

          We plan to recruit 500 women in the treatment phase of the study. Assuming a treatment effect of 0.6, and background rates of 35% and 18%, respectively, for each of the primary outcomes, our study has 85% power to detect a difference between the intervention and the control groups.

          Analysis

          Data will be analysed on the intention-to-treat principle.

          Ethics

          STOPPIT-2 was approved by the South East Scotland Ethics Committee 02 on 29 August 2014, reference number 14/SS/1031 IRAS ID 159610.

          Dissemination

          Peer reviewed journals, presentations at national and international scientific meetings.

          Trial registration number

          ISRCTN98835694 and NCT02235181.

          Related collections

          Most cited references 13

          • Record: found
          • Abstract: found
          • Article: not found

          Preventing preterm births: analysis of trends and potential reductions with interventions in 39 countries with very high human development index.

          Every year, 1·1 million babies die from prematurity, and many survivors are disabled. Worldwide, 15 million babies are born preterm (<37 weeks' gestation), with two decades of increasing rates in almost all countries with reliable data. The understanding of drivers and potential benefit of preventive interventions for preterm births is poor. We examined trends and estimate the potential reduction in preterm births for countries with very high human development index (VHHDI) if present evidence-based interventions were widely implemented. This analysis is to inform a rate reduction target for Born Too Soon. Countries were assessed for inclusion based on availability and quality of preterm prevalence data (2000-10), and trend analyses with projections undertaken. We analysed drivers of rate increases in the USA, 1989-2004. For 39 countries with VHHDI with more than 10,000 births, we did country-by-country analyses based on target population, incremental coverage increase, and intervention efficacy. We estimated cost savings on the basis of reported costs for preterm care in the USA adjusted using World Bank purchasing power parity. From 2010, even if all countries with VHHDI achieved annual preterm birth rate reductions of the best performers for 1990-2010 (Estonia and Croatia), 2000-10 (Sweden and Netherlands), or 2005-10 (Lithuania, Estonia), rates would experience a relative reduction of less than 5% by 2015 on average across the 39 countries. Our analysis of preterm birth rise 1989-2004 in USA suggests half the change is unexplained, but important drivers include non-medically indicated labour induction and caesarean delivery and assisted reproductive technologies. For all 39 countries with VHHDI, five interventions modelling at high coverage predicted a 5% relative reduction of preterm birth rate from 9·59% to 9·07% of livebirths: smoking cessation (0·01 rate reduction), decreasing multiple embryo transfers during assisted reproductive technologies (0·06), cervical cerclage (0·15), progesterone supplementation (0·01), and reduction of non-medically indicated labour induction or caesarean delivery (0·29). These findings translate to roughly 58,000 preterm births averted and total annual economic cost savings of about US$3 billion. We recommend a conservative target of a relative reduction in preterm birth rates of 5% by 2015. Our findings highlight the urgent need for research into underlying mechanisms of preterm births, and development of innovative interventions. Furthermore, the highest preterm birth rates occur in low-income settings where the causes of prematurity might differ and have simpler solutions such as birth spacing and treatment of infections in pregnancy than in high-income countries. Urgent focus on these settings is also crucial to reduce preterm births worldwide. March of Dimes, USA, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Institutes of Health, USA. Copyright © 2013 Elsevier Ltd. All rights reserved.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            The cost of preterm birth throughout childhood in England and Wales.

            Infants born preterm are at increased risk of adverse health and developmental outcomes. Mortality and morbidity after preterm birth impose a burden on finite public sector resources. This study considers the economic consequences of preterm birth from birth to adult life and compares the costs accruing to those born preterm with those born at term. A decision-analytic model was constructed to estimate the costs to the public sector over the first 18 years after birth, stratified by week of gestational age at birth. Costs were discounted and reported in UK pounds at 2006 prices. Probabilistic sensitivity analysis was used to examine uncertainty in the model parameters and generate confidence intervals surrounding the cost estimates. The model estimates the costs associated with a hypothetical cohort of 669601 children and is based on live birth and preterm birth data from England and Wales in 2006. The total cost of preterm birth to the public sector was estimated to be pound2.946 billion (US $4.567 billion), and an inverse relationship was identified between gestational age at birth and the average public sector cost per surviving child. The incremental cost per preterm child surviving to 18 years compared with a term survivor was estimated at pound22885 (US $35471). The corresponding estimates for a very and extremely preterm child were substantially higher at pound61781 (US $95760) and pound94740 (US $146847), respectively. Despite concerns about ongoing costs after discharge from perinatal services, the largest contribution to the economic implications of preterm birth are hospital inpatient costs after birth, which are responsible for 92.0% of the incremental costs per preterm survivor.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis.

              Women with twin pregnancy are at high risk for spontaneous preterm delivery. Progesterone seems to be effective in reducing preterm birth in selected high-risk singleton pregnancies, albeit with no significant reduction in perinatal mortality and little evidence of neonatal benefit. We investigated the use of progesterone for prevention of preterm birth in twin pregnancy. In this double-blind, placebo-controlled trial, 500 women with twin pregnancy were recruited from nine UK National Health Service clinics specialising in the management of twin pregnancy. Women were randomised, by permuted blocks of randomly mixed sizes, either to daily vaginal progesterone gel 90 mg (n=250) or to placebo gel (n=250) for 10 weeks from 24 weeks' gestation. All study personnel and participants were masked to treatment assignment for the duration of the study. The primary outcome was delivery or intrauterine death before 34 weeks' gestation. Analysis was by intention to treat. Additionally we undertook a meta-analysis of published and unpublished data to establish the efficacy of progesterone in prevention of early (<34 weeks' gestation) preterm birth or intrauterine death in women with twin pregnancy. This study is registered, number ISRCTN35782581. Three participants in each group were lost to follow-up, leaving 247 analysed per group. The combined proportion of intrauterine death or delivery before 34 weeks of pregnancy was 24.7% (61/247) in the progesterone group and 19.4% (48/247) in the placebo group (odds ratio [OR] 1.36, 95% CI 0.89-2.09; p=0.16). The rate of adverse events did not differ between the two groups. The meta-analysis confirmed that progesterone does not prevent early preterm birth in women with twin pregnancy (pooled OR 1.16, 95% CI 0.89-1.51). Progesterone, administered vaginally, does not prevent preterm birth in women with twin pregnancy. Chief Scientist Office of the Scottish Government Health Directorate.
                Bookmark

                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                6 December 2018
                : 8
                : 12
                Affiliations
                [1 ] departmentTommy’s Centre for Maternal and Fetal Health, MRC Centre for Maternal and Fetal Health , University of Edinburgh , Edinburgh, UK
                [2 ] departmentEdinburgh Clinical Trials Unit , University of Edinburgh , Edinburgh, UK
                [3 ] departmentCentre for Healthcare Randomised Trials , University of Aberdeen , Aberdeen, UK
                [4 ] departmentUsher Institute , The University of Edinburgh , Edinburgh, UK
                [5 ] departmentHealth Economics Research Centre (HERC), Nuffield Department of Population Health , University of Oxford , Oxford, UK
                [6 ] departmentTommy’s Centre for Maternal and Fetal Health , King’s College London , London, UK
                [7 ] departmentInstitute of Cellular Medicine , University of Newcastle , Newcastle, UK
                [8 ] departmentBarts and the London School of Medicine and Dentistry , Queen Mary University of London , London, UK
                [9 ] departmentFetal Medicine Centre, Birmingham Women’s and Children’s Foundation Trust and College of Medical and Dental Science , University of Birmingham , Birmingham, UK
                [10 ] departmentInstitute for Women’s Health , University College London , London, UK
                [11 ] departmentDepartment of Surgery and Cancer , Imperial College London , London, UK
                [12 ] Multiple Births Foundation , London, UK
                Author notes
                [Correspondence to ] Professor Jane E Norman; jane.norman@ 123456ed.ac.uk
                Article
                bmjopen-2018-026430
                10.1136/bmjopen-2018-026430
                6286620
                30530477
                © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

                Product
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000664, Health Technology Assessment Programme;
                Categories
                Obstetrics and Gynaecology
                Protocol
                1506
                1332
                Custom metadata
                unlocked

                Medicine

                cervical pessary, twin pregnancy, preterm labour, preterm birth

                Comments

                Comment on this article