NCT01220011

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
3 countries

11 active sites

Status
completed

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

October 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 19, 2011

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

7.5 years

First QC Date

October 11, 2010

Last Update Submit

February 11, 2026

Conditions

Blood and Blood DisordersAnemia, NeonatalHematologic DiseaseInfant, Newborn, Diseases

Keywords

Fetoscopic Laser surgeryStage 1 Twin - twin transfusion syndrome

Outcome Measures

Primary Outcomes (1)

  • survival and neurological morbidity at the age of 6 months for each foetus randomized

    6 MONTHS

Study Arms (2)

NO INTERVENTION

EXPERIMENTAL
Procedure: Fetoscopic laser surgery

fetoscopic laser

ACTIVE COMPARATOR
Procedure: Fetoscopic laser surgery

Interventions

Fetoscopic laser surgeryPROCEDURE

Fetoscopic laser surgery

NO INTERVENTIONfetoscopic laser

Eligibility Criteria

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

You may qualify if:

  • TTTS stage 1 (Euro foetus criteria)
  • Gestational age \> 16 and \< 26 weeks
  • Age \> 18
  • Informed consent

You may not qualify if:

  • Therapeutic amniocentesis prior to referral
  • Short cervix \< 15 mm on transvaginal US
  • Severe maternal discomfort:Dyspnea and orthopnea, Abdominal pain \> 4 on a 10-level visual analogic pain scale, Contractions \> 1 per hour
  • PPROM
  • Fetal malformations unrelated to TTTS
  • Follow-up is impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Children's Hospital Colorado and Colorado Fetal Care Center

Aurora, Colorado, 80045, United States

Location

University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences

Baltimore, Maryland, 21000, United States

Location

Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3026, United States

Location

The Ohio State University / OSU Fetal Therapy Program

Columbus, Ohio, 43221, United States

Location

Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University.

Providence, Rhode Island, 02903, United States

Location

The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School

Houston, Texas, 77030, United States

Location

Fetal Therapy Program, Evergrenn Hospital Medical Center

Kirkland, Washington, 98034, United States

Location

Mount Sinai Hospital, University of Toronto

Toronto, Ontario, ON M5X 1X5, Canada

Location

Hospital Ste-Justine

Montreal, Quebec, H3T 1R2, Canada

Location

Necker Enfants Malades

Paris, 75006, France

Location

Related Publications (1)

  • Stirnemann J, Slaghekke F, Khalek N, Winer N, Johnson A, Lewi L, Massoud M, Bussieres L, Aegerter P, Hecher K, Senat MV, Ville Y. Intrauterine fetoscopic laser surgery versus expectant management in stage 1 twin-to-twin transfusion syndrome: an international randomized trial. Am J Obstet Gynecol. 2021 May;224(5):528.e1-528.e12. doi: 10.1016/j.ajog.2020.11.031. Epub 2020 Nov 26.

    PMID: 33248135RESULT

MeSH Terms

Conditions

Hematologic DiseasesAnemia, NeonatalInfant, Newborn, DiseasesFetofetal Transfusion

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesAnemiaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yves VILLE, PUPH

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 13, 2010

Study Start

April 19, 2011

Primary Completion

September 30, 2018

Study Completion

March 31, 2019

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(8)CA(2)FR(1)