Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome

ConditionsTwin to Twin Transfusion as Antepartum Condition Monochorionic Diamniotic Placenta

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorSeattle Children's Hospital

About this trial

The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Single placenta (Monochorionic)

Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)

Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)

Prominent bladder in the recipient/ non-filling bladder in the donor

Disqualifiers

Patients unwilling to participate in the study or to be followed up

Presence of major congenital anomalies incompatible with survival

Active pre-term labor Ruptured membranes

Chorioamnionitis

Trial population

Pregnant persons presenting with a diagnosis of twin to twin transfusion syndrome

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Fetoscopic laser ablation
Procedure/Surgery
Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope.

Treatment groups

2,000 Participants

are divided into 1 treatment group

Group A: Patients presenting with TTTS1 intervention

Trial outcomes

Primary outcomes

Survival

Survival to discharge from the nursery of affected babies

Time frame

Immediately after the surgery to discharge from the hospital after delivery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seattle Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

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