Trans-Amniotic Suture Placement for TTTS
(TTTS TAPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist mothers with Twin-Twin Transfusion Syndrome (TTTS), a condition where twins share an uneven blood supply in the womb. It tests whether using a larger stitch during surgery (Trans-Amniotic Suture Placement) improves safety and effectiveness compared to not using the stitch. Participants will either receive the stitch or not during their fetoscopic laser surgery. The trial includes mothers diagnosed with TTTS or a related condition who are between 18 and 23 weeks pregnant. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance future treatment options for TTTS.
Do I need to stop my current medications for the 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 Trans-Amniotic Suture Placement is safe for TTTS?
Research has shown that using a special stitch inside the womb for patients with Twin-Twin Transfusion Syndrome (TTTS) is well-tolerated. One study found that these patients did not experience unexpected early births, where a baby is born too soon without warning. Additionally, the time between surgery and delivery exceeded expectations. This suggests the stitch did not induce early labor, indicating a positive safety profile. While more information would be beneficial, these findings are encouraging for those considering participation in a trial with this treatment.12345
Why are researchers excited about this trial?
Researchers are excited about Trans-Amniotic Suture Placement for Twin-to-Twin Transfusion Syndrome (TTTS) because it offers a novel approach compared to existing treatments like laser therapy and amnioreduction. Unlike these standard methods, which focus on reducing or eliminating problematic blood flow between twins, Trans-Amniotic Suture Placement involves physically placing a suture to potentially stabilize the condition more directly. This method might offer a more immediate and controlled solution, reducing the risk of complications and improving outcomes for both twins. By addressing the issue mechanically, researchers hope this technique could provide a more reliable and less invasive option for managing TTTS.
What evidence suggests that Trans-Amniotic Suture Placement is effective for TTTS?
This trial will compare the use of a special stitch during surgery to manage Twin-Twin Transfusion Syndrome (TTTS) with no stitch intervention. Studies have shown that using a stitch during surgery can stabilize the pregnancy by closing the membrane, potentially leading to better outcomes. Specifically, previous patients experienced improved results when this technique was used alongside standard laser surgery. The procedure aims to support better healing and reduce complications, potentially resulting in healthier births for twins affected by TTTS.12345
Are You a Good Fit for This Trial?
This trial is for patients with Twin-Twin Transfusion Syndrome (TTTS) who are undergoing fetoscopic laser surgery. Specific eligibility details aren't provided, but typically participants would need to meet certain health standards and be at a stage of pregnancy where the procedure is deemed safe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo fetoscopic laser surgery with or without laparotomy suture placement
Follow-up
Participants are monitored for latency from surgery to delivery and other pregnancy outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Trans-Amniotic Suture Placement
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor