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NCT02235181: STOPPIT-2

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

Completed NA Last updated 25 March 2020
What this trial tests

NA trial testing Arabin Cervical Pessary in Twin Pregnancy With Antenatal Problem in 2,228 participants. Completed in 31 October 2019.

Timeline
1 November 2014
Primary endpoint
31 July 2019
31 October 2019

Quick facts

Lead sponsorUniversity of Edinburgh
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment2,228
Start date1 November 2014
Primary completion31 July 2019
Estimated completion31 October 2019
Sites57 locations across Belgium, United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Edinburgh

Who can join

Adults 16 to 60, female only, with Twin Pregnancy With Antenatal Problem. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis.
    Norman JE, Norrie J, MacLennan G, Cooper D, et al · · 2021 · cited 30× · PMID 33780463 · DOI 10.1371/journal.pmed.1003506
  2. Controversies about the Secondary Prevention of Spontaneous Preterm Birth.
    Kyvernitakis I, Maul H, Bahlmann F. · · 2018 · cited 16× · PMID 29962517 · DOI 10.1055/a-0611-5337
  3. Child outcomes after placement of a cervical pessary in women with a multiple pregnancy: A 4-year follow-up of the ProTWIN trial.
    Simons NE, van de Beek C, van der Lee JH, Opmeer BC, et al · · 2019 · cited 14× · PMID 31032879 · DOI 10.1111/aogs.13630
  4. Open randomised trial of the (Arabin) pessary to prevent preterm birth in twin pregnancy with health economics and acceptability: STOPPIT-2-a study protocol.
    Norman JE, Norrie J, Maclennan G, Cooper D, et al · · 2018 · cited 8× · PMID 30530477 · DOI 10.1136/bmjopen-2018-026430
  5. The Arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix: the STOPPIT 2 RCT.
    Norman JE, Norrie J, MacLennan G, Cooper D, et al · · 2021 · cited 7× · PMID 34219633 · DOI 10.3310/hta25440

Verify or expand the search:

Other trials of Arabin Cervical Pessary

Trials testing the same drug.

Other recruiting trials for Twin Pregnancy With Antenatal Problem

Currently open trials in the same condition.

Other University of Edinburgh trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02235181.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing