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Randomized Controlled Trial
. 2017 Aug 1;17(1):256.
doi: 10.1186/s12884-017-1435-0.

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  1 , Sílvia Arévalo  2 , Liesbeth Lewi  3   4 , Isabel Couck  3   4 , Bettina Hollwitz  5 , Kurt Hecher  5 , Elena Carreras  2
Affiliations
Randomized Controlled Trial

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 et al. BMC Pregnancy Childbirth. .

Abstract

Background: Fetoscopic 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.

Methods: This 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 registration: ClinicalTrials.gov Identifier: NCT01334489 . Registered 04 December 2011.

Keywords: Cervical length; Cervical pessary; Fetoscopic LASER coagulation; Preterm delivery; Twin-to-twin transfusion syndrome.

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Conflict of interest statement

Sponsor Information

Fundació Hospital Universitari Vall d’Hebron – Institut de Recerca (VHIR). Joan Xavier Comella Carnicé. Director General. Vall d’Hebron Institut de Recerca (Edifici Mediterrània, 2ª planta). Hospital Universitari Vall d’Hebron. Passeig Vall d’Hebron, 119–129, 08035 Barcelona. Telf: +34,934,894,275.

Ethics approval and consent to participate

The sponsor, participating centres and investigators ensure that this study is conducted in accordance with the protocol, the principles of the Declaration of Helsinki, ICH Guidelines for Good Clinical Practice and in full conformity with relevant regulations as well as applicable national laws and in accordance with regulations and guidelines applicable to clinical trials relating to medical devices.

The protocol, informed consent form, participant information sheet and any applicable documents were submitted to the respective Ethics Committees (EC) and regulatory authorities, and written approval has been obtained. All substantial amendments to the originally approved documents will also be sent to the respective authorities for approval.

The study did not begin until the approval of the EC and Director’s consent was obtained.

The Vall d’Hebron university hospital clinical research ethics opinion, as the reference Ethics Committee, first approved this randomised controlled trial. Afterwards, all the participating centres also obtained their own EC approval.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

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