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 range
18 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)