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

Study Description

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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	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	142 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
Study Start Date :	April 2011
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	July 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: NO INTERVENTION	Procedure: Fetoscopic laser surgery; Fetoscopic laser surgery
Active Comparator: fetoscopic laser	Procedure: Fetoscopic laser surgery; Fetoscopic laser surgery

Outcome Measures

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Primary Outcome Measures :

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

Eligibility Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Last Update Posted:	December 21, 2016
Last Verified:	December 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Fetoscopic Laser surgery; Stage 1 Twin - twin transfusion syndrome

Additional relevant MeSH terms:

Hematologic Diseases; Infant, Newborn, Diseases; Anemia, Neonatal; Anemia