Clinical trial NCT00345852: Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
Official title: A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Twin to Twin Transfusion Syndrome
Keywords: twin to twin transfusion syndrome
fetoscopic selective laser photocoagulation
amnioreduction
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2006-06-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Survival of donor twin at 30 days after birth and no treatment failure
measure: Survival of recipient twin at 30 days after birth and no treatment failure
Secondary outcomes:
measure: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
measure: Gestational age at delivery
measure: Placental insufficiency
measure: Cardiac outcome: echocardiographic evidence of cardiac compromise
measure: Neurologic outcome: evidence of brain injury preceding birth by MRI
measure: Postnatal comorbidity
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Columbia-Presbyterian Medical Center
state: New York
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Timothy M Crombleholme, MD
role: PRINCIPAL_INVESTIGATOR
References: