Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery (TTTS1)
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| ClinicalTrials.gov Identifier: NCT01220011 |
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Recruitment Status :
Recruiting
First Posted : October 13, 2010
Last Update Posted : December 21, 2016
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
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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 |
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 : | 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 |
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 :
- survival and neurological morbidity at the age of 6 months for each foetus randomized [ Time Frame: 6 MONTHS ]
Information from the National Library of Medicine
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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
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 |
| 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: | December 21, 2016 |
| Last Verified: | December 2016 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
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Fetoscopic Laser surgery Stage 1 Twin - twin transfusion syndrome |
Additional relevant MeSH terms:
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Hematologic Diseases Infant, Newborn, Diseases Anemia, Neonatal Anemia |