Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery

Completed · Not applicable

Conditions studied: Blood and Blood Disorders, Anemia, Neonatal, Hematologic Disease, Infant, Newborn, Diseases

In brief

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.

Key facts

Study ID

NCT01220011

Run by

Assistance Publique - Hôpitaux de Paris

People needed

179

Starts

2011-04-19

Expected to finish

2019-03-31

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• TTTS stage 1 (Euro foetus criteria)
• Gestational age > 16 and < 26 weeks
• Age > 18
• Informed consent

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado and Colorado Fetal Care Center — Aurora, Colorado, United States
• University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences — Baltimore, Maryland, United States
• Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• The Ohio State University / OSU Fetal Therapy Program — Columbus, Ohio, United States
• Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University. — Providence, Rhode Island, United States
• The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School — Houston, Texas, United States
• Fetal Therapy Program, Evergrenn Hospital Medical Center — Kirkland, Washington, United States
• Mount Sinai Hospital, University of Toronto — Toronto, Ontario, Canada
• Hospital Ste-Justine — Montreal, Quebec, Canada
• Necker Enfants Malades — Paris, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.