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

Twin Twin Transfusion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02122328
• Other study ID #: HS-09-00680
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 9, 2010
• Est. completion date: May 30, 2024

Study information

• Verified date: June 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 642
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Syndrome
• Twin Twin Transfusion Syndrome

Intervention

Procedure:
• Sequential laser photocoagulation of communicating vessels.

• Selective laser photocoagulation of communicating vessels

Locations

Country	Name	City	State
United States	Hollywood Presbyterian Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fetal/neonatal/infant outcomes		Birth to 6 months of life
Primary	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	Surgical complications		21 post-operative days