Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

Brief Title

Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

Official Title

Selective Laser Photocoagulation of Communicating Vessels in Twin-Twin Transfusion Syndrome

Brief Summary

      Patients undergo a detailed ultrasound examination to rule out the presence of congenital
      anomalies, and to assess the hemodynamic status of the fetuses. Patients with confirmed TTTS
      will be considered candidates for the trial. Patients will be counseled about the risks and
      benefits of all treatment options and will be free to choose any treatment option. They will
      then be asked to sign an informed consent. The procedure will be performed under local
      anesthesia. After a 2-3 mm skin incision, and under ultrasound guidance, the trocar will be
      introduced in the amniotic cavity of the Recipient twin. The communicating vessels will be
      located endoscopically and will be lasered with YAG laser energy. An accessory port may be
      required in some cases. The procedure will be monitored both endoscopically and
      sonographically. The presence of fetal heart activity will be noted often during the
      procedure. An amniodrainage of the larger sac may be performed at the time of the procedure.
      The patient will remain hospitalized 1-3 days and will undergo an ultrasound assessment on
      the first post operative day. Patients will undergo a weekly ultrasound examination for four
      weeks after the initial therapeutic procedure. Sonographic parameters to evaluate will
      include: maximum vertical pocket of fluid in each sac, visualization of the fetal bladders,
      absence or presence of hydrops, and Doppler studies of the umbilical artery, umbilical vein,
      ductus venosus, and middle cerebral artery. After delivery babies will be assessed by their
      corresponding neonatologists or pediatricians. Infants admitted to the neonatal intensive
      care unit will be followed through their discharge. Evidence of neurological or cardiac
      morbidity will be sought in each twin. If either of these complications is suspected,
      evaluation by pediatric neurology or pediatric cardiology will be requested. Babies will be
      followed up for neonatal, infant and childhood morbidity or mortality. It is requested that
      all placentas be delivered fresh to Tampa General Hospital in an icebox container for
      assessment. Placentas will be discarded after analysis.
    



Study Type

Observational


Primary Outcome

The primary study objective is to evaluate neonatal/infant survival 6 months after birth.

Secondary Outcome

 The secondary study objective is to evaluate the effects of surgery on postnatal neurological morbidity. For the purposes of this clinical trial, neurological morbidity includes any of the following conditions diagnosed within 6 months of birth

Condition

Twin Twin Transfusion Syndrome

Intervention

Selective Laser Photocoagulation of Communicating Vessels

Study Arms / Comparison Groups

 TTTS treatment method
Description:  This is an observational trial. Patients who meet eligibility criteria and give written informed consent will have SLPCV. All subjects will receive ongoing standard-of-care prenatal care for the duration of their pregnancy from their referring perinatologist or obstetrician.

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

Device

Estimated Enrollment

77

Start Date

October 2006

Completion Date

February 2009

Primary Completion Date

February 2009

Eligibility Criteria

        Inclusion Criteria

        To be eligible, patients must meet the following criteria:

          1. Maternal age 18 to 55 years

          2. Gestational age: 16 weeks, 0 days to 26 weeks, 0 days.

          3. Confirmed TTTS patients, who by definition meet the following sonographic criteria:

               1. Single placenta.

               2. Polyhydramnios: maximum vertical pocket >= 8 cm in the recipient twin, prior to
                  amniodrainage.

               3. Oligohydramnios: maximum vertical pocket <=2 cm in the donor twin, prior to
                  amniodrainage.

               4. Thin dividing membrane (absence of twin peak sign) or absence of dividing
                  membrane (monoamniotic).

               5. Same gender, if visible.

          4. Patients choosing laser therapy that have undergone prior therapeutic amniocentesis
             may be included.

          5. Patients with an anterior placenta may be included.

          6. Triplet gestations with two or three fetuses sharing the same placenta may be
             included.

          7. Patients must be able to give written informed consent. Inclusion Criteria 5.2
             Exclusion Criteria

        The following criteria would exclude patients from participation in the study:

          1. Patients unable or unwilling to participate in the study or to be followed up.

          2. Patients unable to give written informed consent.

          3. Presence of major congenital anomalies that may not warrant surgery.

          4. Known unbalanced chromosomal complement.

          5. Prior intentional septostomy (purposely making a hole in the dividing membrane).

          6. Ruptured membranes.

          7. Chorioamnionitis.

          8. Abnormal intracranial ultrasound findings of either fetus to include, but not limited
             to: intraventricular hemorrhage, porencephalic cysts, hydrocephalus, Dandy-Walker
             syndrome, holoprosencephaly and agenesis of the corpus callosum. Isolated
             ventriculomegaly (atrium 10-19 mm) may or may not be used an exclusion criteria.

          9. Placental abruption.

         10. Active labor.

         11. Jehovah's Witness.

         12. Any other patient deemed inappropriate for the study by the principal investigator.
      

Gender

Female

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Ruben A Quintero, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01622049

Organization ID

#105118


Responsible Party

Sponsor

Study Sponsor

University of South Florida


Study Sponsor

Ruben A Quintero, MD, Principal Investigator, University of South Florida


Verification Date

November 2012