Status:
COMPLETED
Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Blood and Blood Disorders
Anemia, Neonatal
Eligibility:
FEMALE
18+ years
Phase:
NA
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 c...
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 ...
Eligibility Criteria
Inclusion
- TTTS stage 1 (Euro foetus criteria)
- Gestational age \> 16 and \< 26 weeks
- Age \> 18
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01220011
Start Date
April 19 2011
End Date
March 31 2019
Last Update
July 20 2020
Active Locations (11)
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1
Children's Hospital Colorado and Colorado Fetal Care Center
Aurora, Colorado, United States, 80045
2
University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences
Baltimore, Maryland, United States, 21000
3
Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026
4
The Ohio State University / OSU Fetal Therapy Program
Columbus, Ohio, United States, 43221