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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

Tracking Information
First Submitted Date  ICMJE October 11, 2010
First Posted Date  ICMJE October 13, 2010
Last Update Posted Date September 3, 2018
Actual Study Start Date  ICMJE April 19, 2011
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2010)
survival and neurological morbidity at the age of 6 months for each foetus randomized [ Time Frame: 6 MONTHS ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01220011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery
Official Title  ICMJE A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood and Blood Disorders
  • Anemia, Neonatal
  • Hematologic Disease
  • Infant, Newborn, Diseases
Intervention  ICMJE Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery
Study Arms  ICMJE
  • Experimental: NO INTERVENTION
    Intervention: Procedure: Fetoscopic laser surgery
  • Active Comparator: fetoscopic laser
    Intervention: Procedure: Fetoscopic laser surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
179
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2010)
142
Estimated Study Completion Date  ICMJE March 31, 2019
Estimated Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01220011
Other Study ID Numbers  ICMJE K090601
ID RCB : 2010-A00026-33 ( Other Identifier: AFSSAPS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yves VILLE, PUPH Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP