Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

Brief Title

Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

Official Title

USFetus Randomized Clinical Trial: Sequential vs. Standard Laser Treatment of Twin-twin Transfusion Syndrome

Brief Summary

      The investigators hypothesize that treatment of twin-twin transfusion syndrome (TTTS) using
      sequential laser photocoagulation of communicating vessels (SQLPCV) over the predominant
      method, selective laser photocoagulation of communicating vessels (SLPCV), may provide
      vascular stability to the donor fetus. The primary objective is to evaluate the perinatal
      outcome, specifically, donor intrauterine survival of TTTS managed by SQLPCV vs. SLPCV in a
      prospective, randomized trial.
    



Study Type

Interventional


Primary Outcome

To compare donor intrauterine survival (alive at birth) for those undergoing SQLPCV vs. SLPCV.

Secondary Outcome

 Surgical complications

Condition

Twin Twin Transfusion Syndrome

Intervention

Sequential laser photocoagulation of communicating vessels.

Study Arms / Comparison Groups

 Selective procedure
Description:  Selective laser photocoagulation of communicating vessels.

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

542

Start Date

June 2010

Completion Date

June 2023

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

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

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

               -  Single placenta.

               -  Polyhydramnios: maximum vertical pocket ≥ 8 cm in the recipient twin, prior to
                  amniodrainage.

               -  Oligohydramnios: maximum vertical pocket ≤ 2 cm in the donor twin, prior to
                  amniodrainage.

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

               -  Same gender, if visible.

               -  Quintero Stages 1-4.

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

          -  Patients with an anterior placenta may be included.

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

          -  Patients must be able to give written informed consent.

        Exclusion Criteria:

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

          -  Patients unable to give written informed consent.

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

          -  Known unbalanced chromosomal complement.

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

          -  Ruptured membranes.

          -  Chorioamnionitis.

          -  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 as exclusion criteria.

          -  Placental abruption.

          -  Active labor.

          -  Patient unwilling to receive blood products.

          -  Recipient twin with a middle cerebral artery peak systolic velocity > 1.5 multiples of
             the median (indicative of fetal anemia).

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

Gender

Female

Ages

16 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ramen Chmait, MD, 626-356-3360, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02122328

Organization ID

HS-09-00680


Responsible Party

Principal Investigator

Study Sponsor

University of Southern California


Study Sponsor

Ramen Chmait, MD, Principal Investigator, University of Southern California


Verification Date

November 2020