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Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

Primary Purpose

Twin to Twin Transfusion Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fetoscopic Selective Laser Photocoagulation
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Twin to Twin Transfusion Syndrome focused on measuring twin to twin transfusion syndrome, fetoscopic selective laser photocoagulation, amnioreduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Both twins are alive TTTS diagnosed prior to 22 weeks gestation Monochorionic diamniotic gestation Like sex twins Single placental mass Thin intertwin membrane Oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm) Polyhydramnios with deepest vertical pocket of > 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of > 6 cm if previous amnioreduction) Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present No associated structural abnormalities No sonographic evidence of CNS injury at time of entry No preterm labor No maternal medical contraindication to anesthesia or surgery Exclusion Criteria: Failure to meet all inclusion criteria TTTS presenting after 22 weeks gestation Randomization after 24 weeks gestation Cervical length < 2.0 cm post initial Presence of cervical cerclage Uterine anomaly Refusal to accept randomization Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution

Sites / Locations

  • University of California-San Francisco
  • Evanston Northwestern Healthcare
  • New York University School of Medicine
  • Columbia-Presbyterian Medical Center
  • Good Samaritan Hospital
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Magee-Women's Hospital
  • University of Texas Medical Branch
  • University of Utah Hospital
  • Eastern Virginia Medical School
  • University of Washington Medical Center

Outcomes

Primary Outcome Measures

Survival of donor twin at 30 days after birth and no treatment failure
Survival of recipient twin at 30 days after birth and no treatment failure

Secondary Outcome Measures

Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
Gestational age at delivery
Placental insufficiency
Cardiac outcome: echocardiographic evidence of cardiac compromise
Neurologic outcome: evidence of brain injury preceding birth by MRI
Postnatal comorbidity

Full Information

First Posted
June 27, 2006
Last Updated
June 28, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT00345852
Brief Title
Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
Official Title
A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Children's Hospital Medical Center, Cincinnati

4. Oversight

5. Study Description

Brief Summary
This is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.
Detailed Description
We hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (TTTS). We propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage II-IV) twin-twin transfusion syndrome (TTTS). Primary Outcomes: Survival of donor twin at 30 days after birth and no treatment failure; Survival of recipient twin at 30 days after birth and no treatment failure; Secondary Outcomes: Survival times of each twin in utero or after birth (which may be censored at 30 days after birth); Gestational age at delivery; Placental insufficiency; Cardiac outcome: echocardiographic evidence of cardiac compromise; Neurologic outcome: evidence of brain injury preceding birth by MRI; Postnatal comorbidity

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin to Twin Transfusion Syndrome
Keywords
twin to twin transfusion syndrome, fetoscopic selective laser photocoagulation, amnioreduction

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Fetoscopic Selective Laser Photocoagulation
Primary Outcome Measure Information:
Title
Survival of donor twin at 30 days after birth and no treatment failure
Title
Survival of recipient twin at 30 days after birth and no treatment failure
Secondary Outcome Measure Information:
Title
Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)
Title
Gestational age at delivery
Title
Placental insufficiency
Title
Cardiac outcome: echocardiographic evidence of cardiac compromise
Title
Neurologic outcome: evidence of brain injury preceding birth by MRI
Title
Postnatal comorbidity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both twins are alive TTTS diagnosed prior to 22 weeks gestation Monochorionic diamniotic gestation Like sex twins Single placental mass Thin intertwin membrane Oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm) Polyhydramnios with deepest vertical pocket of > 8 cm with or without Doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of > 6 cm if previous amnioreduction) Decompressed bladder in donor not seen to fill during the ultrasound examination (stage II, III, or IV), unless Doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present No associated structural abnormalities No sonographic evidence of CNS injury at time of entry No preterm labor No maternal medical contraindication to anesthesia or surgery Exclusion Criteria: Failure to meet all inclusion criteria TTTS presenting after 22 weeks gestation Randomization after 24 weeks gestation Cervical length < 2.0 cm post initial Presence of cervical cerclage Uterine anomaly Refusal to accept randomization Unable to pursue prenatal care at an approved center coordinated by one of the participating institutions Unable to pursue postnatal evaluation at a NICHD Neonatal Research Network Institution
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M Crombleholme, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia-Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Magee-Women's Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.fetalcarecenter.org/medicine/therapies/ttts/
Description
Fetal Care Center of Cincinnati Twin-Twin Transfusion Syndrome (TTTS) webpage

Learn more about this trial

Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

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