Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery (TTTS1)
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ClinicalTrials.gov Identifier: NCT01220011 |
Recruitment Status
:
Recruiting
First Posted
: October 13, 2010
Last Update Posted
: December 21, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blood and Blood Disorders Anemia, Neonatal Hematologic Disease Infant, Newborn, Diseases | Procedure: Fetoscopic laser surgery | Phase 4 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: NO INTERVENTION |
Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery
|
Active Comparator: fetoscopic laser |
Procedure: Fetoscopic laser surgery
Fetoscopic laser surgery
|
- 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, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Contact: Yves Ville, PUPH | Yville@gmail.com |
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 |
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:
Fetoscopic Laser surgery Stage 1 Twin - twin transfusion syndrome |
Additional relevant MeSH terms:
Hematologic Diseases Infant, Newborn, Diseases Anemia, Neonatal Anemia |