Recruiting

Laser Photocoagulation

Sponsor:

Seattle Children's Hospital

Code:

NCT05008744

Conditions

Twin to Twin Transfusion as Antepartum Condition

Monochorionic Diamniotic Placenta

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Fetoscopic laser ablation

Study Details

Brief summary:

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.

Conditions

Twin to Twin Transfusion as Antepartum Condition

Monochorionic Diamniotic Placenta

Study ID

NCT05008744

Start date

Oct 1, 2021

Status verified date

Apr, 2024

Completion date

Oct 1, 2031

Anticipated

Primary completion date

Oct 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients presenting with TTTS

Pregnant persons between 16 and 36 weeks of pregnancy with a diagnosis of twin to twin transfusion syndrome

Interventions

Fetoscopic laser ablation

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 outcome measure

  • Survival [ Time Frame: Immediately after the surgery to discharge from the hospital after delivery ]

Central Contacts and Locations

Central contacts

Martin P Walker, MD

206-987-3539martin.walker@seattlechildrens.org

Melissa Dorn, RN MN

206-987-4137melissa.dorn@seattlechildrens.org

Locations

Seattle Childrens Hospital

Recruiting

Seattle, Washington, United States, 98015

Contacts

Martin P Walker, MD

206-987-3539martin.walker@seattlechildrens.org

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Apr 19, 2024

Last verified

Apr, 2024

Keywords

  • Twin
  • Monochorionic
  • Fetoscopy
  • Laser

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2024-04-19.