Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery

Infant, Newborn, Diseases Clinical Trial

— TTTS1  

Official title:

A Cluster Randomized Trial Comparing a Conservative Management and Primary Laser Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220011
• Other study ID #: K090601
• Secondary ID: ID RCB : 2010-A0
• Status: Completed
• Phase: N/A
• Start date: April 19, 2011
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: March 31, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Neonatal
• Blood and Blood Disorders
• Hematologic Disease
• Hematologic Diseases
• Infant, Newborn, Diseases

Intervention

Procedure:
• Fetoscopic laser surgery
Fetoscopic laser surgery

Locations

Country	Name	City	State
Canada	Hospital Ste-Justine	Montreal	Quebec
Canada	Mount Sinai Hospital, University of Toronto	Toronto	Ontario
France	Necker Enfants Malades	Paris
United States	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival and neurological morbidity at the age of 6 months for each foetus randomized		6 MONTHS