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Completed

NCT Number: NCT02122328

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

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.

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Key information

Age range

16 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hollywood Presbyterian Medical Center

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sequential laser photocoagulation of communicating vessels.

Procedure

Selective laser photocoagulation of communicating vessels

Procedure

Primary outcomes

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

    Time frame: Birth

    A comparison of donor survival at birth will be made between subjects assigned to the sequential (SQLPCV) procedure versus those assigned to the selective (SLPCV) procedure.

Secondary outcomes

  1. Surgical complications

    Time frame: 21 post-operative days

Other outcomes

  1. Fetal/neonatal/infant outcomes

    Time frame: Birth to 6 months of life

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2014
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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