Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05008744

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

The purpose of this study is to evaluate the use of diode laser photocoagulation of the communicating vessels in twin-to- twin transfusion syndrome (TTTS) with respect to maternal, fetal and neonatal outcomes.

Recruiting

Interested in participating?

Request Info

Key information

Sex eligibility

Female

Study type

Observational

Primary location

Seattle Childrens Hospital, Seattle, Washington, United States

Loading trial locations.

About this study

Patients will undergo an intake evaluation followed by a detailed ultrasound examination to rule out the presence of congenital anomalies and to assess the hemodynamic status of the fetuses and any pre-existing cerebral damage. The following data will be collected, as is identical to the standard of care in evaluating monochorionic twins

Maternal

  • Age
  • Gravidity and parity
  • BMI
  • Race/ethnicity
  • Gestational age
  • The presence of any symptoms
  • Cervical length

Fetal

  • Estimated fetal weight
  • Detailed anatomy
  • Doppler evaluation of umbilical cord, ductus venosus and middle cerebral arteries
  • Evaluation of the myocardial performance indices
  • Amniotic fluid volume
  • Placental position
  • Cord insertions

Patients will then be counseled about the risks and benefits of the procedure and will be asked to sign an informed consent.

The procedure will be performed under a spinal or local anesthesia at the discretion of the anesthesiologist and surgeon based upon placental position, maternal hemodynamic stability and maternal anxiety and ability to cooperate. Ultrasound guidance will help to select an appropriate incisional site. Under ultrasound guidance, a 2 mm skin incision will be made and a 10 French Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity. An amniotic fluid sample will be obtained and sent for microbiological studies. A small aliquot of fluid will also be set aside for future institutional review board approved studies (see detail regarding banking below).

The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope. The Laser used is a Dornier Diode laser using a power of 30-40 Watts. At the conclusion of the anastomotic ablation, an ablation line will be created across the vascular equator, effectively dichorionizing the placenta. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be documented at the beginning and end of the procedure. An amniodrainage of the larger sac will be performed at the conclusion of the procedure to leave the amniotic fluid volume of that sac at a normal level.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Single placenta (Monochorionic)
  • Polyhydramnios present in recipient twin (Greater than 8 cm maximum vertical pocket below 20 weeks and greater than a 10 cm pocket for greater than 20 weeks gestational age)
  • Oligohydramnios present in donor twin (Less than 2 cm maximum vertical pocket)
  • Prominent bladder in the recipient/ non-filling bladder in the donor
  • Thin dividing membrane

Exclusion criteria

  • Patients unwilling to participate in the study or to be followed up
  • Presence of major congenital anomalies incompatible with survival
  • Active pre-term labor Ruptured membranes
  • Chorioamnionitis
  • Vaginal bleeding

Treatment and study plan

Fetoscopic laser ablation

Procedure

Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity.

The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope.

Primary outcomes

  1. Survival

    Time frame: Immediately after the surgery to discharge from the hospital after delivery

    Survival to discharge from the nursery of affected babies

Study contacts

Contact information is provided by the study sponsor or research team.

Martin P Walker, MD

CONTACT

[email protected]

206-987-3539 ext. 73539

Melissa Dorn, RN MN

CONTACT

[email protected]

206-987-4137 ext. 74137

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome (TTTS)

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Aug 17, 2021
Registry last updated
Apr 19, 2024

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.

Published trials that share one or more normalized conditions with this study.