Fetoscopic Laser Photocoagulation for Twin-Twin Transfusion Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Ahmed Nassr, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Baylor College of Medicine

Disqualifiers: Triplets, higher order multiples

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate whether the entry technique surgeons use to get inside the uterus to perform fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome has an effect on the rates of chorioamniotic membrane separation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fetoscopic Laser Photocoagulation for Twin-Twin Transfusion Syndrome?

Research shows that fetoscopic laser photocoagulation, a minimally invasive surgery, is used to treat twin-to-twin transfusion syndrome by correcting abnormal blood vessel connections in the placenta, which helps regulate blood flow to both babies. Studies from various centers, including those in Brazil and Hong Kong, have reported positive outcomes in managing this condition with this treatment.

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How is fetoscopic laser photocoagulation different from other treatments for twin-twin transfusion syndrome?

Fetoscopic laser photocoagulation is unique because it is a minimally invasive surgery that uses a small camera and laser to seal off abnormal blood vessel connections in the placenta, which helps regulate blood flow between twins. This approach directly targets the root cause of twin-twin transfusion syndrome, unlike other treatments that may only manage symptoms.

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Eligibility Criteria

This trial is for pregnant individuals with monochorionic-diamniotic twin pregnancies experiencing twin-to-twin transfusion syndrome (TTTS) who choose to undergo fetoscopic laser photocoagulation. It excludes those who opt out of the procedure and pregnancies with triplets or more.

Inclusion Criteria

I am choosing laser treatment for my twin pregnancy complication.

Exclusion Criteria

I chose not to have laser treatment for my twin pregnancy complication.

Triplets and higher order multiple gestations.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo fetoscopic laser photocoagulation using either direct entry or Seldinger technique

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for chorioamniotic membrane separation and other complications up to hospital discharge

Up to 5 days

Inpatient monitoring

Extended Follow-up

Investigators collect follow-up data on the health of the participant and the babies until the babies turn one month old

1 month

Participant Groups

The study investigates how different surgical techniques for entering the uterus affect outcomes in TTTS treatment using fetoscopic laser photocoagulation, focusing on rates of chorioamniotic membrane separation post-procedure.

Group I: Direct Entry Active Control 1 Intervention

Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting a sharp trocar through a small incision in the skin. The trocar is then removed and a small tube called a cannula is left in place.

Group II: Seldinger Technique Active Control 1 Intervention

Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting needle through a small incision in the skin and running a guide wire through the needle so a thin tube called a cannula can be placed over the wire.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Texas Children's Hospital - Pavilion for Women Houston, TX

Who Is Running the Clinical Trial?

Baylor College of Medicine Lead Sponsor

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome treatment: initial experience in tertiary reference center in Brazil. [2022] To evaluate the initial maternal and perinatal outcomes of fetoscopic laser photocoagulation for the treatment of twin-to-twin transfusion syndrome (TTTS) in a referral center in Brazil.

2. United States pubmed.ncbi.nlm.nih.gov

Incidence of complications in twin-twin transfusion syndrome after selective fetoscopic laser photocoagulation: a single-center experience. [2018] The purpose of this study was to evaluate the incidence of complications after selective fetoscopic laser photocoagulation for twin-twin transfusion syndrome (TTTS).

3. United States pubmed.ncbi.nlm.nih.gov

Selective fetoscopic laser photocoagulation of superficial placental anastomoses for the treatment of severe twin-twin transfusion syndrome. [2022] To report our initial institutional experience with fetoscopic laser photocoagulation of placental anastomoses in severe twin-twin transfusion syndrome using a 1.0 mm endoscope.

4. Germany pubmed.ncbi.nlm.nih.gov

FetNet: a recurrent convolutional network for occlusion identification in fetoscopic videos. [2021] Fetoscopic laser photocoagulation is a minimally invasive surgery for the treatment of twin-to-twin transfusion syndrome (TTTS). By using a lens/fibre-optic scope, inserted into the amniotic cavity, the abnormal placental vascular anastomoses are identified and ablated to regulate blood flow to both fetuses. Limited field-of-view, occlusions due to fetus presence and low visibility make it difficult to identify all vascular anastomoses. Automatic computer-assisted techniques may provide better understanding of the anatomical structure during surgery for risk-free laser photocoagulation and may facilitate in improving mosaics from fetoscopic videos.

5. China pubmed.ncbi.nlm.nih.gov

Fetoscopic laser photocoagulation in the management of twin-twin transfusion syndrome: local experience from Hong Kong. [2022] To review the perinatal outcome of monochorionic twin pregnancies treated by fetoscopic laser coagulation for twin-twin transfusion syndrome.

6. Germany pubmed.ncbi.nlm.nih.gov

Robust fetoscopic mosaicking from deep learned flow fields. [2023] Fetoscopic laser photocoagulation is a minimally invasive procedure to treat twin-to-twin transfusion syndrome during pregnancy by stopping irregular blood flow in the placenta. Building an image mosaic of the placenta and its network of vessels could assist surgeons to navigate in the challenging fetoscopic environment during the procedure.

7. United States pubmed.ncbi.nlm.nih.gov

Pregnancy outcomes following early fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome at 16 weeks' gestation. [2023] Ample evidence supports fetoscopic laser photocoagulation of placental anastomoses as a first-line treatment for twin-to-twin transfusion syndrome, but little is known about the outcomes following procedures conducted in the early second trimester.

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

A prospective pilot study of fetoscopic laser surgery for twin-to-twin transfusion syndrome between 26 and 27 weeks of gestation. [2017] The aim of this study is to clarify the feasibility and efficacy of fetoscopic laser photocoagulation of placental vascular communicating vessels (FLP) on twin-twin transfusion syndrome (TTTS) after 26 weeks of gestation.