Overview

This trial is active, not recruiting.

Condition twin to twin transfusion syndrome
Treatment fetoscopic selective laser photocoagulation
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator Children's Hospital Medical Center, Cincinnati
Start date March 2002
End date May 2007
Trial size 150 participants
Trial identifier NCT00345852, NCT00109694, R01-HD41149

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Survival of donor twin at 30 days after birth and no treatment failure
time frame:
Survival of recipient twin at 30 days after birth and no treatment failure
time frame:

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Randomized Multicenter Trial of Amnioreduction Vs Selective Fetoscopic Laser Photocoagulation for the Treatment of Severe Twin-Twin Transfusion Syndrome
Principal investigator Timothy M Crombleholme, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in June 2007.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).