CompletedNot Applicable

Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

United States642 participantsStarted 2010-06-09

Plain-language summary

The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant method, selective laser photocoagulation of communicating vessels (SLPCV), may provide vascular stability to the donor fetus. The primary objective is to evaluate the perinatal outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a prospective, randomized trial.

Who can participate

Age range

16 Years – 55 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: * Gestational age: 16 weeks, 0 days to 26 weeks, 0 days. * Confirmed TTTS patients, who by definition meet the following sonographic criteria: * Single placenta. * Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to amniodrainage. * Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to amniodrainage. * Thin dividing membrane (absence of twin peak sign) or absence of dividing membrane (monoamniotic). * Same gender, if visible. * Quintero Stages 1-4. * Patients choosing laser therapy that have undergone prior therapeutic amniocentesis may be included. * Patients with an anterior placenta may be included. * Triplet gestations with two or three fetuses sharing the same placenta may be included. * Patients must be able to give written informed consent. Exclusion Criteria: * Patients unable or unwilling to participate in the study or to be followed up. * Patients unable to give written informed consent. * Presence of major congenital anomalies that may not warrant surgery. * Known unbalanced chromosomal complement. * Prior intentional septostomy (purposely making a hole in the dividing membrane). * Ruptured membranes. * Chorioamnionitis. * Abnormal intracranial ultrasound findings of either fetus to include, but not limited to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated ventriculomegaly (atr…

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

To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.

Timeframe: Birth

Trial details

NCT IDNCT02122328

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Twin Twin Transfusion Syndrome trials