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Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery

NCT01220011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2026-02-13

No results posted yet for this study

Summary

The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.

Conditions

  • Blood and Blood Disorders
  • Anemia, Neonatal
  • Hematologic Disease
  • Infant, Newborn, Diseases

Interventions

PROCEDURE

Fetoscopic laser surgery

Fetoscopic laser surgery

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yves VILLE, PUPH · Assistance Publique Hopitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-19
Primary Completion
2018-09-30
Completion
2019-03-31

Countries

  • United States
  • Canada
  • France

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 NCT01220011 on ClinicalTrials.gov