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

Study Overview
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Brief Summary
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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.

Official Title
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USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

Conditions
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Twin Twin Transfusion Syndrome

Intervention / Treatment
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* Procedure: Sequential laser photocoagulation of communicating vessels.
* Procedure: Selective laser photocoagulation of communicating vessels


Participation Criteria
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Eligibility Criteria
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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 (atrium 10-19 mm) may or may not be used as exclusion criteria. Placental abruption. Active labor. Patient unwilling to receive blood products. Recipient twin with a middle cerebral artery peak systolic velocity > 1.5 multiples of the median (indicative of fetal anemia). Any other patient deemed inappropriate for the study by the principal investigator.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selective procedure<br>Selective laser photocoagulation of communicating vessels. | Procedure: Selective laser photocoagulation of communicating vessels<br> <br> |
| Experimental: Sequential procedure<br>Sequential laser photocoagulation of communicating vessels | Procedure: Sequential laser photocoagulation of communicating vessels.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV. | A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure. | Birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications |  | 21 post-operative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Twin twin transfusion syndrome, Sequential laser photocoagulation of communicating vessels