Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

Twin to Twin Transfusion Syndrome Clinical Trial

Official title:

A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00345852
• Other study ID #: R01HD041149
• Status: Active, not recruiting
• Phase: N/A
• First received: June 27, 2006
• Last updated: June 28, 2007
• Start date: March 2002
• Est. completion date: May 2007

Study information

• Verified date: June 2006
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.

Description:

We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity

Other known NCT identifiers

• NCT00109694

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Both twins are alive

• TTTS diagnosed prior to 22 weeks gestation

• Monochorionic diamniotic gestation

• Like sex twins

• Single placental mass

• Thin intertwin membrane

• Oligohydramnios in donor twin (deepest vertical pocket of = 2 cm)

• Polyhydramnios with deepest vertical pocket of > 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of > 6 cm if previous amnioreduction)

• Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present

• No associated structural abnormalities

• No sonographic evidence of CNS injury at time of entry

• No preterm labor

• No maternal medical contraindication to anesthesia or surgery

Exclusion Criteria:

• Failure to meet all inclusion criteria

• TTTS presenting after 22 weeks gestation

• Randomization after 24 weeks gestation

• Cervical length < 2.0 cm post initial

• Presence of cervical cerclage

• Uterine anomaly

• Refusal to accept randomization

• Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions

• Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Syndrome
• Twin to Twin Transfusion Syndrome

Intervention

Procedure:
• Fetoscopic Selective Laser Photocoagulation

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	University of Texas Medical Branch	Galveston	Texas
United States	Columbia-Presbyterian Medical Center	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Magee-Women's Hospital	Pittsburgh	Pennsylvania
United States	University of Utah Hospital	Salt Lake City	Utah
United States	University of California-San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of donor twin at 30 days after birth and no treatment failure
Primary	Survival of recipient twin at 30 days after birth and no treatment failure
Secondary	Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
Secondary	Gestational age at delivery
Secondary	Placental insufficiency
Secondary	Cardiac outcome: echocardiographic evidence of cardiac compromise
Secondary	Neurologic outcome: evidence of brain injury preceding birth by MRI
Secondary	Postnatal comorbidity

External Links

•   Fetal Care Center of Cincinnati Twin-Twin Transfusion Syndrome (TTTS) webpage