Clinical trial NCT02122328: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
Official title: USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Twin Twin Transfusion Syndrome
Keywords: Twin twin transfusion syndrome
Sequential laser photocoagulation of communicating vessels
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 642
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
timeFrame: Birth
Secondary outcomes:
measure: Surgical complications
timeFrame: 21 post-operative days
Other outcomes:
measure: Fetal/neonatal/infant outcomes
timeFrame: Birth to 6 months of life
Locations:
city: Los Angeles
country: United States
facility: Hollywood Presbyterian Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Ramen Chmait, MD
role: PRINCIPAL_INVESTIGATOR
References: