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

Primary Purpose

Twin Twin Transfusion Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sequential laser photocoagulation of communicating vessels.
Selective laser photocoagulation of communicating vessels
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Twin Twin Transfusion Syndrome focused on measuring Twin twin transfusion syndrome, Sequential laser photocoagulation of communicating vessels

Eligibility Criteria

16 Years - 55 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hollywood Presbyterian Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Selective procedure

Sequential procedure

Arm Description

Selective laser photocoagulation of communicating vessels.

Sequential laser photocoagulation of communicating vessels

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Surgical complications

Full Information

First Posted
April 16, 2014
Last Updated
June 12, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT02122328
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2010 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Twin Transfusion Syndrome
Keywords
Twin twin transfusion syndrome, Sequential laser photocoagulation of communicating vessels

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
642 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selective procedure
Arm Type
Active Comparator
Arm Description
Selective laser photocoagulation of communicating vessels.
Arm Title
Sequential procedure
Arm Type
Experimental
Arm Description
Sequential laser photocoagulation of communicating vessels
Intervention Type
Procedure
Intervention Name(s)
Sequential laser photocoagulation of communicating vessels.
Intervention Type
Procedure
Intervention Name(s)
Selective laser photocoagulation of communicating vessels
Primary Outcome Measure Information:
Title
To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.
Description
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.
Time Frame
Birth
Secondary Outcome Measure Information:
Title
Surgical complications
Time Frame
21 post-operative days
Other Pre-specified Outcome Measures:
Title
Fetal/neonatal/infant outcomes
Time Frame
Birth to 6 months of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramen Chmait, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hollywood Presbyterian Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

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

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