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The Trial of Pessary After Laser for TTTS

NCT01334489 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2020-08-27

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

DEVICE

Arabin Cervical Pessary

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.

Sponsors & Collaborators

  • Maternal-Infantil Vall d´Hebron Hospital

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Bürgerhospital Frankfurt

    collaborator OTHER

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Elena Carreras, PhD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2020-01-31
Completion
2020-06-25

Countries

  • Belgium
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334489 on ClinicalTrials.gov