Evidence map›Paper›PMID 30530477›Full record

ArticleBMJ open2018

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

Jane E Norman, John Norrie, Graeme Maclennan, David Cooper, Sonia Whyte, Sarah Cunningham Burley, Joel B E Smith, Andrew Shennan, Stephen C Robson, Steven Thornton and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02235181 (An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02235181 nacompletednot on this map

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)

TypeinterventionalSponsorUniversity of EdinburghRan2014 to 2019Enrolled2,228ConditionsTwin Pregnancy With Antenatal ProblemArmsArabin Cervical Pessary
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Spontaneous preterm birth prevention in multiple pregnancy.The obstetrician & gynaecologist : the journal for continuing professional development from the Royal College of Obstetricians & Gynaecologists · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jane E NormanTommy's Centre for Maternal and Fetal Health, MRC Centre for Maternal and Fetal Health, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-6031-6953
John NorrieEdinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
Graeme MaclennanCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
David CooperCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Sonia WhyteTommy's Centre for Maternal and Fetal Health, MRC Centre for Maternal and Fetal Health, University of Edinburgh, Edinburgh, UK.
Sarah Cunningham BurleyUsher Institute, The University of Edinburgh, Edinburgh, UK.
Joel B E SmithHealth Economics Research Centre (HERC), Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Andrew ShennanTommy's Centre for Maternal and Fetal Health, King's College London, London, UK.
Stephen C RobsonInstitute of Cellular Medicine, University of Newcastle, Newcastle, UK.
Steven ThorntonBarts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Mark D KilbyFetal Medicine Centre, Birmingham Women's and Children's Foundation Trust and College of Medical and Dental Science, University of Birmingham, Birmingham, UK.
Neil MarlowInstitute for Women's Health, University College London, London, UK.
Sarah J StockUsher Institute, The University of Edinburgh, Edinburgh, UK.ORCID 0000-0003-4308-856X
Philip R BennettDepartment of Surgery and Cancer, Imperial College London, London, UK.
Jane DentonMultiple Births Foundation, London, UK.

Funding

Chief Scientist Office HSRU1Department of Health HTA/13/04/22
6 · The paper itself

Abstract

introductionThe 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.

methodsSTOPPIT-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.

Indexed as

PessariesPregnancy, TwinCervical Length MeasurementCervix UteriCost SavingsFemaleGestational AgeHumansMulticenter Studies as TopicPatient Acceptance of Health CarePragmatic Clinical Trials as TopicPregnancyPremature BirthUnited Kingdomcervical pessarypreterm birthpreterm labourtwin pregnancy

Identifiers

PMID30530477
PMCPMC6286620

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.