Twin to Twin Transfusion Syndrome
Conditions
Keywords
twin to twin transfusion syndrome, fetoscopic selective laser photocoagulation, amnioreduction
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
Interventions
PROCEDUREFetoscopic Selective Laser Photocoagulation
Sponsors
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Placental insufficiency | — |
| Cardiac outcome: echocardiographic evidence of cardiac compromise | — |
| Survival times of each twin in utero or after birth (which may be censored at 30 days after birth) | — |
| Postnatal comorbidity | — |
| Neurologic outcome: evidence of brain injury preceding birth by MRI | — |
| Gestational age at delivery | — |
Countries
United States
Outcome results
None listed