Fetoscopic Selective Laser Photocoagulation in Twin-Twin Transfusion Syndrome

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

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
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Survival times of each twin in utero or after birth (which may be censored at 30 days after birth)

Condition

Twin to Twin Transfusion Syndrome

Intervention

Fetoscopic Selective Laser Photocoagulation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

150

Start Date

March 2002

Completion Date

May 2007


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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Timothy M Crombleholme, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00345852

Organization ID

R01HD041149



Study Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

 Children's Hospital Medical Center, Cincinnati

Study Sponsor

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


Verification Date

June 2006