216 Participants Needed

Fetoscopic Laser Photocoagulation for Twin-Twin Transfusion Syndrome

AN
BJ
Overseen ByBecky Johnson, MS, CCRP
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.34678

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.

Research Team

AN

Ahmed Nassr, MD, PhD

Principal Investigator

Baylor College of Medicine

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.

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

Treatment Details

Interventions

  • Fetoscopic Laser Photocoagulation
Trial Overview 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.
Participant Groups
2Treatment groups
Active Control
Group I: Direct EntryActive Control1 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 TechniqueActive Control1 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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

Findings from Research

Fetoscopic laser photocoagulation for treating twin-to-twin transfusion syndrome (TTTS) in 24 procedures showed promising maternal and perinatal outcomes, with a survival rate of 58.3% for donor fetuses until the end of gestation.
The study found that the severity of TTTS, classified by the Quintero system, significantly impacted fetal survival rates, with higher death rates in more severe cases, indicating the importance of early intervention.
Fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome treatment: initial experience in tertiary reference center in Brazil.Barbosa, MM., Martins Santana, EF., Milani, HJF., et al.[2022]
In a study of 152 cases treated with selective fetoscopic laser photocoagulation for twin-twin transfusion syndrome (TTTS), the overall incidence of complications was significant, with early complications occurring in 31% of cases and late complications in 39%.
Fetal survival rates were high, with 77.5% of fetuses surviving overall and 88% of pregnancies resulting in at least one twin surviving, highlighting the efficacy of the procedure despite the risk of complications.
Incidence of complications in twin-twin transfusion syndrome after selective fetoscopic laser photocoagulation: a single-center experience.Habli, M., Bombrys, A., Lewis, D., et al.[2018]
In a study of 19 twin pregnancies with severe twin-twin transfusion syndrome (TTTS), fetoscopic laser therapy using a 1.0 mm endoscope resulted in an overall survival rate of 52.6%, which is comparable to outcomes reported with larger endoscopes.
The therapy was more effective in stage III TTTS, with a survival rate of 61.1% for both twins, compared to 45.0% for stage IV, indicating that earlier intervention may lead to better outcomes.
Selective fetoscopic laser photocoagulation of superficial placental anastomoses for the treatment of severe twin-twin transfusion syndrome.Ruano, R., Brizot, Mde L., Liao, AW., et al.[2022]

References

Fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome treatment: initial experience in tertiary reference center in Brazil. [2022]
Incidence of complications in twin-twin transfusion syndrome after selective fetoscopic laser photocoagulation: a single-center experience. [2018]
Selective fetoscopic laser photocoagulation of superficial placental anastomoses for the treatment of severe twin-twin transfusion syndrome. [2022]
FetNet: a recurrent convolutional network for occlusion identification in fetoscopic videos. [2021]
Fetoscopic laser photocoagulation in the management of twin-twin transfusion syndrome: local experience from Hong Kong. [2022]
Robust fetoscopic mosaicking from deep learned flow fields. [2023]
Pregnancy outcomes following early fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome at 16 weeks' gestation. [2023]
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]
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