Fetoscopic Laser Photocoagulation for Twin Placenta Complications

Overseen By Michael A Belfort, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michael A Belfort

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called fetoscopic selective laser photocoagulation. It targets women expecting twins with a shared placenta who face complications. The researchers aim to assess the safety and effectiveness of this treatment using special tools called fetoscopes. Women considering this treatment for pregnancy complications might be suitable candidates. As an unphased trial, it offers participants the chance to contribute to important research that could enhance outcomes for future pregnancies.

Do I need to stop my current medications for this trial?

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 prior data suggests that the fetoscopes used in this study are safe for patients?

Research has shown that fetoscopic laser photocoagulation is generally well-tolerated and is the preferred treatment for twin-twin transfusion syndrome (TTTS). This procedure uses a laser to close abnormal blood vessel connections between twins sharing a placenta. Studies have found that survival rates are high, with about 75% of cases resulting in at least one twin surviving. However, like any medical procedure, some risks exist. Post-laser TAPS (twin anemia-polycythemia sequence) can occur in up to 15% of cases treated with this laser therapy. This condition involves blood flow issues between the twins but is a known possible complication. Overall, the treatment is considered effective and has significantly improved outcomes for TTTS cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fetoscopic laser photocoagulation for twin placenta complications because it offers a targeted approach that directly addresses the root cause of twin-twin transfusion syndrome (TTTS). Unlike traditional treatments that may involve amnioreduction or septostomy, which manage symptoms without resolving the underlying problem, this technique uses a fetoscope to precisely seal off abnormal blood vessel connections in the placenta with a laser. This method not only aims to prevent further complications but also can improve outcomes for both twins by restoring a more balanced blood flow. The precision and minimally invasive nature of this procedure make it a promising advancement in prenatal care for affected pregnancies.

What evidence suggests that fetoscopic laser photocoagulation is effective for twin placenta complications?

Research has shown that a special laser treatment called fetoscopic selective laser photocoagulation effectively treats twin-to-twin transfusion syndrome (TTTS), a serious issue in twin pregnancies. One study found that this treatment improved survival rates compared to other methods, with about 85% of pregnancies resulting in at least one twin surviving. Another study found that 83% of pregnancies had one or more babies survive after the procedure. This trial will involve all participants undergoing this laser treatment, which closes off the shared blood vessels in the placenta to balance blood flow between the twins. Evidence indicates that this method can greatly improve outcomes for complicated twin pregnancies. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael A Belfort, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with twins sharing one placenta (monochorionic-diamniotic pregnancies) who choose to undergo a procedure called fetoscopic selective laser photocoagulation to treat complications.

Inclusion Criteria

I am choosing to have laser surgery for my complicated twin pregnancy.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo fetoscopic selective laser photocoagulation using investigational fetoscopes

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness immediately after the procedure

Immediate post-procedure period

What Are the Treatments Tested in This Trial?

Interventions

• Fetoscopic Selective Laser Photocoagulation
• Fetoscopy Sets for Anterior and Posterior Placentas

Trial Overview The study is testing new types of fetoscopes, which are special telescopes used in surgery on the fetus. The focus is on their safety and effectiveness when treating twin-to-twin transfusion syndrome via laser therapy.

How Is the Trial Designed?

Group I: Fetoscopes for Selective Laser Photocoagulation Experimental Treatment 1 Intervention

Single arm study. All patients will undergo selective laser photocoagulation with the use of the fetoscopes in this study.

Who Is Running the Clinical Trial?

Michael A Belfort

Lead Sponsor

Trials

5

Recruited

510+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7930304/

Outcomes following selective fetoscopic laser ablation for ... Twin-to-twin transfusion syndrome (TTTS) is the most common serious complication, occurring in approximately 15% of MC twin pregnancies. Untreated TTTS carries ...

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.14806

Perinatal outcomes following fetoscopic laser surgery for early ... Although gestational age at delivery was 3 weeks earlier in TTTS with fetoscopic laser surgery at <18 weeks, there was no difference in outcomes ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933325001144

Management of twin‐to‐twin transfusion syndrome A 2004 randomized controlled trial showed that laser photocoagulation provides better survival rates than serial amnioreduction.4 Since then, fetoscopic laser ...

4. bmrat.org bmrat.org/index.php/BMRAT/article/view/868

Evaluation of the success of fetoscopic laser coagulation in ... Results: Postoperative survival rates at 30 days were 32.2% for both twins, 53% for either twin, and 85.2% for at least one twin. A notable ...

5. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-05997-5

Developmental outcomes for survivors of placental laser ... Of 116 pregnancies (113 twin, 3 triplet), 96 (83%) resulted in 1 + surviving fetuses. 57/113 (50%) twin pregnancies resulted in 2 survivors, 36 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5969296/

Fetoscopic laser photocoagulation for twin–twin transfusion ... Thus, with the recent significant improvement of survival rates, survival rates of 70% for both twins and more than 90% for at least one twin can be expected ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211515001724

Outcome following selective fetoscopic laser ablation for ... Fetoscopic laser ablation is the established first-line therapy for severe TTTS, and an overall survival rate of approximately 75% may be expected adopting ...

8. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/pd.6576

Perinatal outcomes of fetoscopic selective laser ... Spontaneous TAPS complicates 5%–6% of multifetal gestations, while post-laser TAPS complicates up to 15% of TTTS cases treated with laser ...

9. mayoclinic.org mayoclinic.org/medical-professionals/obstetrics-gynecology/news/laser-therapy-for-twin-twin-transfusion-syndrome-offers-best-outcomes/mac-20509521

Laser therapy for twin-twin transfusion syndrome offers ... Twin-twin transfusion syndrome can be treated with fetal laser photocoagulation (FLP), which selectively and sequentially ablates connections, depending on the ...

10. tandfonline.com tandfonline.com/doi/full/10.1080/17474086.2020.1720643

Full article: Twin-twin transfusion syndrome in the era of ... Survival of at least one twin increased from 70 to 88% [Citation8]. This study also shows a significant improvement in double survival with the more recently ...