Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

United States Department of Health and Human Services (HHS)

Status

Unknown

Conditions

Twin to Twin Transfusion Syndrome

Treatments

Procedure: Fetoscopic Selective Laser Photocoagulation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00345852

R01HD041149

Details and patient eligibility

About

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

Full 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

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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