Trial reportHealth technology assessment (Winchester, England)2021
The Arabin pessary to prevent preterm birth in women with a twin pregnancy and a short cervix: the STOPPIT 2 RCT.
Trial report in Health technology assessment (Winchester, England), 2021. 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 6 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy in Woman With a Short Cervix (STOPPIT-2)
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.
- Interventions to prevent preterm birth following fetoscopic laser surgery for twin-to-twin transfusion syndrome: systematic review and meta-analysis.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2025Pooled it
- The Lioness™ device: a prospective non-randomized safety and feasibility study of a novel device for preterm birth delay and prevention.BMC pregnancy and childbirth · 2025Article
- Clinical guidance VVOG: Antenatal care for twin pregnancies.European journal of obstetrics & gynecology and reproductive biology: X · 2025Article
- Multiple pregnancies, the myometrium and the role of mechanical factors in the timing of labour.Current research in physiology · 2023Article
- Article
- A nomogram to predict preterm birth in twin pregnancies.American journal of translational research · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 12 institutions in 1 country.
Funding
Abstract
backgroundPreterm birth is common in twins and accounts for significant mortality and morbidity. There are no effective preventative treatments. Some studies have suggested that, in twin pregnancy complicated by a short cervix, the Arabin pessary, which fits around the cervix and can be inserted as an outpatient procedure, reduces preterm birth and prevents neonatal morbidity.
objectiveSTOPPIT 2 aimed to evaluate the clinical utility of the Arabin cervical pessary in preventing preterm birth in women with a twin pregnancy and a short cervix.
designSTOPPIT 2 was a pragmatic, open label, multicentre randomised controlled trial with two treatment group - the Arabin pessary plus standard care (intervention) and standard care alone (control). Participants were initially recruited into the screening phase of the study, when cervical length was measured. Women with a measured cervical length of ≤ 35 mm were then recruited into the treatment phase of the study. An economic evaluation considered cost-effectiveness and a qualitative substudy explored the experiences of participants and clinicians.
settingAntenatal clinics in the UK and elsewhere in Europe.
participantsWomen with twin pregnancy at < 21 weeks' gestation with known chorionicity and gestation established by scan at ≤ 16 weeks' gestation.
interventionsUltrasound scan to establish cervical length. Women with a cervical length of ≤ 35 mm at 18
main outcome measuresObstetric - all births before 34
resultsA total of 2228 participants were recruited to the screening phase, of whom 2170 received a scan and 503 were randomised: 250 to Arabin pessary and 253 to standard care alone. The rate of the primary obstetric outcome was 18.4% (46/250) in the intervention group and 20.6% (52/253) in the control group (adjusted odds ratio 0.87, 95% confidence interval 0.55 to 1.38; LIMITATIONS: There was the possibility of a type II error around smaller than anticipated benefit.
conclusionsIn this study, the Arabin pessary did not reduce preterm birth or adverse neonatal outcomes in women with a twin pregnancy and a short cervix. The pessary either is ineffective at reducing preterm birth or has an effect size of < 0.4. FUTURE WORK: Women with twin pregnancy remain at risk of preterm birth; work is required to find treatments for this.
trial registrationCurrent Controlled Trials ISRCTN98835694 and ClinicalTrials.gov NCT02235181.
fundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
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Registered trials
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