This is a study to compare two treatments (Amnioreduction vs. Selective Fetoscopic Laser Photocoagulation [SFLP]) in patients with severe twin to twin transfusion syndrome.

Condition	Treatment or Intervention
Twin Transfusion Syndrome	Procedure: Selective Fetoscopic Laser Photocoagulation  Procedure: Amnioreduction

Further Study Details: 

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
Expected Total Enrollment:  150

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00109694

Victoria M Shokrollah, BS, MT      215 590 0983    shokrollah@email.chop.edu
Jeffrey D Dragone, BS, MT      215 590 6050    dragone@email.chop.edu

California
      University of California-San Francisco, San Francisco,  California,  94143,  United States; Recruiting
      Hollywood Presbyterian Medical Center, Los Angeles,  California,  90027,  United States; Recruiting
Illinois
      Evanston Northwestern Healthcare, Evanston,  Illinois,  60201,  United States; Recruiting
Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States; Recruiting
New York
      Columbia-Presbyterian Medical Center, New York,  New York,  10032,  United States; Recruiting
      Mount Sinai Medical Center, New York,  New York,  10029,  United States; Recruiting
      New York University School of Medicine, New York,  New York,  10016-6497,  United States; Recruiting
Ohio
      Cincinnati Children’s Hospital, Cincinnati,  Ohio,  45229-3039,  United States; Recruiting
      University of Cincinnati, Cincinnati,  Ohio,  45267-0526,  United States; Recruiting
      Good Samaritan Hospital, Cincinnati,  Ohio,  45220-2489,  United States; Recruiting
Pennsylvania
      The Children’s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Magee-Women’s Hospital, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Texas
      The University of Texas Medical Branch, Galveston,  Texas,  77555,  United States; Recruiting
Utah
      University of Utah Hospital, Salt Lake City,  Utah,  84143,  United States; Recruiting
Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23507,  United States; Recruiting
Washington
      University of Washington Medical Center, Seattle,  Washington,  98195,  United States; Recruiting

Study chairs or principal investigators

Timothy M Crombleholme, MD,  Principal Investigator,  Children's Hospital Medical Center - Cincinnati   

Study ID Numbers:  R01HD41149; NIH TTTS Trial
Record last reviewed:  April 2005
Last Updated:  May 2, 2005
Record first received:  May 2, 2005
ClinicalTrials.gov Identifier:  NCT00109694
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03