Evidence map›Paper›PMID 28764674›Full record

Trial reportBMC pregnancy and childbirth2017

Arabin cervical pessary for prevention of preterm birth in cases of twin-to-twin transfusion syndrome treated by fetoscopic LASER coagulation: the PECEP LASER randomised controlled trial.

Carlota Rodó, Sílvia Arévalo, Liesbeth Lewi, Isabel Couck, Bettina Hollwitz, Kurt Hecher, Elena Carreras

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01334489 (Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Laser Coagulation), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
11.8field-weighted citation impact, top 1% of its field
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.

NCT01334489 naterminatednot on this map

Arabin Cervical Pessary for Prevention of Preterm Birth in Cases of Twin-to-twin Transfusion Syndrome Treated by Fetoscopic Laser Coagulation: The PECEP Laser Trial

TypeinterventionalSponsorHospital Universitari Vall d'Hebron Research InstituteRan2012 to 2020Enrolled352ConditionsPremature BirthArmsArabin Cervical Pessary
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

  1. Cervical pessary for preventing preterm birth.The Cochrane database of systematic reviews · 2013
    Pooled it
  2. Article
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

7 authors at 3 institutions in 3 countries.

Carlota RodóMaternal - Fetal Medicine Unit. Department of Obstetrics, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Catalunya, Spain. crodo@vhebron.net.ORCID http://orcid.org/0000-0001-8801-5677
Sílvia ArévaloMaternal - Fetal Medicine Unit. Department of Obstetrics, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Catalunya, Spain.
Liesbeth LewiDepartment of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
Isabel CouckDepartment of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
Bettina HollwitzDepartment of Obstetrics and Prenatal Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Kurt HecherDepartment of Obstetrics and Prenatal Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Elena CarrerasMaternal - Fetal Medicine Unit. Department of Obstetrics, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Catalunya, Spain.
Universitat Autònoma de Barcelona · ESKU Leuven · BEUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFetoscopic LASER coagulation of the placental anastomoses has changed the prognosis of twin-twin transfusion syndrome. However, the prematurity rate in this cohort remains very high. To date, strategies proposed to decrease the prematurity rate have shown inconclusive, if not unfavourable results.

methodsThis is a randomised controlled trial to investigate whether a prophylactic cervical pessary will lower the incidence of preterm delivery in cases of twin-twin transfusion syndrome requiring fetoscopic LASER coagulation. Women eligible for the study will be randomised after surgery and allocated to either pessary or expectant management. The pessary will be left in place until 37 completed weeks or earlier if delivery occurs. The primary outcome is delivery before 32 completed weeks. Secondary outcomes are a composite of adverse neonatal outcome, fetal and neonatal death, maternal complications, preterm rupture of membranes and hospitalisation for threatened preterm labour. 352 women will be included in order to decrease the rate of preterm delivery before 32 weeks' gestation from 40% to 26% with an alpha-error of 0.05 and 80% power. DISCUSSION: The trial aims at clarifying whether the cervical pessary prolongs the pregnancy in cases of twin-twin transfusion syndrome regardless of cervical length at the time of fetoscopy.

trial registrationClinicalTrials.gov Identifier: NCT01334489 . Registered 04 December 2011.

Indexed as

PessariesCervix UteriClinical ProtocolsFemaleFetofetal TransfusionFetoscopyGestational AgeHumansLaser CoagulationPregnancyPregnancy OutcomePregnancy, TwinPremature BirthTreatment OutcomeCervical lengthCervical pessaryFetoscopic LASER coagulationPreterm deliveryTwin-to-twin transfusion syndrome

Identifiers

PMID28764674
PMCPMC5540345
OpenAlexW2739912423

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.