Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery (TTTS1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01220011
First received: October 11, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Blood and Blood Disorders
Anemia, Neonatal
Hematologic Disease
Infant, Newborn, Diseases
Procedure: Fetoscopic laser surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • survival and neurological morbidity at the age of 6 months for each foetus randomized [ Time Frame: 6 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NO INTERVENTION Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery
Other Name: Fetoscopic laser surgery
Active Comparator: fetoscopic laser Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery
Other Name: Fetoscopic laser surgery

Detailed Description:

Although we demonstrated the overall benefit of fetoscopic laser surgery as first-line treatment in twin-twin transfusion syndrome (TTTS), indications in early stage TTTS are controversial. Indeed, a conservative management with close follow-up is offered in some centers as first-line management for QUINTERO stage 1 TTTS, although this strategy has not been formally compared to first-line fetoscopic placental surgery. The objective of this trial is to compare both strategies for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. Patients randomized to a conservative management will be followed on a weekly basis as long as the syndrome remains stable using obstetrical and fetal parameters and until an adequate gestational age is reached allowing delivery. Cases progressing to stage ≥ 2 or with a worsening of obstetrical parameters during follow-up in this group will be actively treated by percutaneous laser coagulation. Patients allocated to the "immediate laser" group will be treated by fetoscopic laser surgery within 24 h following randomization. The primary end-point encompasses survival and neurological morbidity at the age of 6 months for each foetus randomized. Analyses and power computations use a cluster-trial methodology that accounts for the inter-twin correlation, with many benefits over more traditional designs using a per-pregnancy outcome. With proportions of 60% and 75% meaning a clinically relevant difference of 15% between the groups, 200 fetuses or equivalently 100 pregnancies would be needed in each arm to reach a power of 80% with an alpha-risk of 5%, allowing 2 interim analyses based upon LAN-DEMETS boundaries and an O'Brien-Fleming function. Inclusion criteria, interventions and randomisation were investigated through a preliminary survey across potential participating centers. Based on this survey, it is anticipated that 3 years will be needed to achieve the requested number of patients. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220011

Contacts
Contact: Yves Ville, PUPH Yville@gmail.com

Locations
United States, Colorado
Children's Hospital Colorado and Colorado Fetal Care Center Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Timothy M. Crombleholme, MD    855-413-3825      
Principal Investigator: Timothy M. Crombleholme, MD         
United States, Maryland
University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences Not yet recruiting
Baltimore, Maryland, United States, 21000
Contact: Ahmet Baschet, MD    410-328-7850      
Principal Investigator: Ahmet Baschet, MD         
United States, Ohio
Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3026
Contact: Foong-Yen Lim, MD    888-338-2559      
Principal Investigator: Foong-Yen Lim, MD         
The Ohio State University / OSU Fetal Therapy Program Not yet recruiting
Columbus, Ohio, United States, 43221
Contact: Richard W. O'Shaughnessy, MD    614-293-8083      
Principal Investigator: Richard W. O'Shaughnessy, MD         
United States, Pennsylvania
Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Julie Moldenhauer, MD    800-468-8376      
Principal Investigator: Julie Moldenhauer, MD         
United States, Rhode Island
Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University. Recruiting
Providence, Rhode Island, United States, 02903
Contact: François I Luks, MD, PHD    401-228-0559      
Principal Investigator: François I Luks, MD, PHD         
United States, Texas
The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School Recruiting
Houston, Texas, United States, 77030
Contact: Anthony Johnson, DO    832-325-7288      
Principal Investigator: Anthony Johnson, DO         
United States, Washington
Fetal Therapy Program, Evergrenn Hospital Medical Center Not yet recruiting
Kirkland, Washington, United States, 98034
Contact: Mertin Walker, MD    425-899-3537      
Principal Investigator: Martin Walker, MD         
Canada, Ontario
Mount Sinai Hospital, University of Toronto Not yet recruiting
Toronto, Ontario, Canada, ON M5X 1X5
Contact: Greg RYAN, MB    416-586-8415      
Principal Investigator: Greg Ryan, MB         
Canada, Quebec
Hospital Ste-Justine Not yet recruiting
Montreal, Quebec, Canada, H3T 1R2
Contact: François Audibert, MD, Msc    514-345-7768      
Principal Investigator: François Audibert, MD, Msc         
France
Necker Enfants Malades Recruiting
Paris, France, 75006
Contact: YVES VILLE, PU-PH    +33 (0)1 44 49 40 30 ext +33    Yville@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves VILLE, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01220011     History of Changes
Other Study ID Numbers: K090601, ID RCB : 2010-A00026-33
Study First Received: October 11, 2010
Last Updated: April 28, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fetoscopic Laser surgery
Stage 1 Twin - twin transfusion syndrome

Additional relevant MeSH terms:
Anemia
Anemia, Neonatal
Hematologic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 21, 2014