Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
United States150 participantsStarted 2002-03
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Survival of donor twin at 30 days after birth and no treatment failure
2
Survival of recipient twin at 30 days after birth and no treatment failure
Trial details
NCT IDNCT00345852
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)