Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00345852
First received: June 27, 2006
Last updated: June 28, 2007
Last verified: June 2006
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Purpose
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 | Intervention |
|---|---|
|
Twin to Twin Transfusion Syndrome |
Procedure: Fetoscopic Selective Laser Photocoagulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | May 2007 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345852
Locations
| United States, California | |
| University of California-San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Illinois | |
| Evanston Northwestern Healthcare | |
| Evanston, Illinois, United States, 60201 | |
| United States, New York | |
| Columbia-Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Magee-Women's Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
| United States, Utah | |
| University of Utah Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
| Principal Investigator: | Timothy M Crombleholme, MD | Children's Hospital Medical Center, Cincinnati |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00345852 History of Changes |
| Obsolete Identifiers: | NCT00109694 |
| Other Study ID Numbers: | R01-HD41149 |
| Study First Received: | June 27, 2006 |
| Last Updated: | June 28, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
twin to twin transfusion syndrome fetoscopic selective laser photocoagulation amnioreduction |
Additional relevant MeSH terms:
|
Fetofetal Transfusion Anemia, Neonatal Anemia Hematologic Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 22, 2013