NCT01334489

Brief Summary

Placing a cervical pessary in severe twin-to-twin transfusion syndrome (TTTS) cases treated by fetoscopic laser coagulation (FLC) decreases the spontaneous preterm birth rate.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

7.1 years

First QC Date

April 12, 2011

Last Update Submit

August 25, 2020

Conditions

Premature Birth

Keywords

Monochorionic pregnancyTwin to twin transfusion syndromeCervical pessaryCervical length

Outcome Measures

Primary Outcomes (1)

  • Delivery before 32 weeks

    Rate of delivery before 32 weeks

    Within the first 15 days after delivery

Secondary Outcomes (12)

  • Birth weight

    Within the first 15 days after delivery

  • Fetal or neonatal death

    Within the first 15 days after the death

  • Neonatal morbidity

    30 days after the discharge from the hospital

  • Significant maternal adverse events

    Within 15 days after discharge from the hospital

  • Physical or psychological intolerance to pessary

    Within 15 days after discharge from hospital

  • +7 more secondary outcomes

Study Arms (2)

Usual management

NO INTERVENTION

Usual management of monochorionic pregnancy without the pessary placement

Arabin Cervical Pessary

OTHER

The pessary will be inserted 24 hours after fetal surgery in the exploration room. This procedure does not need anaesthesia and it does not need to be done in a surgery room. During the following explorations the correct placement of the pessary is assessed, and if it does not, it can be easily adjusted. The pessary will be removed at 37 weeks of gestation, or before if any unexpected event occurs.

Device: Arabin Cervical Pessary

Interventions

Arabin Cervical PessaryDEVICE

The Arabin cervical pessary, which is CE-certified for preventing SPB (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC). It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain.

Arabin Cervical Pessary

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Monochorionic twin pregnancies with severe TTTS requiring intrauterine surgery
  • Less than 26 weeks
  • Minimal age of 18 years
  • Informed consent signature

You may not qualify if:

  • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • Cerclage prior to randomisation
  • Uterine malformation
  • Placenta previa
  • Active vaginal bleeding at the moment of randomization
  • Spontaneous rupture of membranes at the time of randomization
  • Death of both twins after the surgery
  • Monochorionic-monoamniotic twin pregnancy
  • Silicone allergy
  • Current participation in other RCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UZ Leuven. Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Frauenklinik - Zentrum für Ultraschalldiagnostik und Pränatalmedizin Bürgerhospital und Clementine Kinderhospital gemeinnützige GmbH

Frankfurt, 60318, Germany

Location

University Medical Center Eppendorf

Hamburg, 20246, Germany

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (6)

  • Carreras E, Arevalo S, Bello-Munoz JC, Goya M, Rodo C, Sanchez-Duran MA, Peiro JL, Cabero L. Arabin cervical pessary to prevent preterm birth in severe twin-to-twin transfusion syndrome treated by laser surgery. Prenat Diagn. 2012 Dec;32(12):1181-5. doi: 10.1002/pd.3982. Epub 2012 Oct 11.

    PMID: 23055333BACKGROUND

  • Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3.

    PMID: 22475493BACKGROUND

  • Goya M, Pratcorona L, Higueras T, Perez-Hoyos S, Carreras E, Cabero L. Sonographic cervical length measurement in pregnant women with a cervical pessary. Ultrasound Obstet Gynecol. 2011 Aug;38(2):205-9. doi: 10.1002/uog.8960. Epub 2011 Jul 18.

    PMID: 21305638BACKGROUND

  • Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.

    PMID: 23924878BACKGROUND

  • Rodo C, Maiz N, Arevalo S, Lewi L, Couck I, Hollwitz B, Kyvernitakis I, Carreras E, Hecher K. The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2024 Aug;231(2):252.e1-252.e11. doi: 10.1016/j.ajog.2023.11.1245. Epub 2023 Nov 29.

    PMID: 38036166DERIVED

  • Rodo C, Arevalo S, Lewi L, Couck I, Hollwitz B, Hecher K, Carreras E. 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. BMC Pregnancy Childbirth. 2017 Aug 1;17(1):256. doi: 10.1186/s12884-017-1435-0.

    PMID: 28764674DERIVED

Related Links

MeSH Terms

Conditions

Premature BirthFetofetal Transfusion

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAnemia, NeonatalAnemiaHematologic DiseasesHemic and Lymphatic DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Elena Carreras, PhD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 13, 2011

Study Start

December 1, 2012

Primary Completion

January 1, 2020

Study Completion

June 25, 2020

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

DE(2)BE(1)ES(1)