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

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ClinicalTrials.gov Identifier: NCT01220011
Recruitment Status : Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Blood and Blood Disorders Anemia, Neonatal Hematologic Disease Infant, Newborn, Diseases Procedure: Fetoscopic laser surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery
Actual Study Start Date : April 19, 2011
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NO INTERVENTION Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery

Active Comparator: fetoscopic laser Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery




Primary Outcome Measures :
  1. survival and neurological morbidity at the age of 6 months for each foetus randomized [ Time Frame: 6 MONTHS ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220011


Locations
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United States, Colorado
Children's Hospital Colorado and Colorado Fetal Care Center
Aurora, Colorado, United States, 80045
United States, Maryland
University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences
Baltimore, Maryland, United States, 21000
United States, Ohio
Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026
The Ohio State University / OSU Fetal Therapy Program
Columbus, Ohio, United States, 43221
United States, Pennsylvania
Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University.
Providence, Rhode Island, United States, 02903
United States, Texas
The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School
Houston, Texas, United States, 77030
United States, Washington
Fetal Therapy Program, Evergrenn Hospital Medical Center
Kirkland, Washington, United States, 98034
Canada, Ontario
Mount Sinai Hospital, University of Toronto
Toronto, Ontario, Canada, ON M5X 1X5
Canada, Quebec
Hospital Ste-Justine
Montreal, Quebec, Canada, H3T 1R2
France
Necker Enfants Malades
Paris, France, 75006
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yves VILLE, PUPH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01220011     History of Changes
Other Study ID Numbers: K090601
ID RCB : 2010-A00026-33 ( Other Identifier: AFSSAPS )
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Fetoscopic Laser surgery
Stage 1 Twin - twin transfusion syndrome
Additional relevant MeSH terms:
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Hematologic Diseases
Anemia, Neonatal
Infant, Newborn, Diseases
Anemia