Trans-Amniotic Suture Placement for TTTS

(TTTS TAPS Trial)

Overseen By Erin Watters

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Higher order pregnancies, severe anomalies, others

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

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized trial for patients that are diagnosed with Twin-Twin Transfusion Syndrome (TTTS) who are receiving a fetoscopic laser surgery to evaluate the effectiveness and safety of a laparotomy closure.

Eligibility Criteria

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

A skilled surgeon has confirmed a safe approach for my surgery.

Cervical length >2.5 cm preoperatively

Gestational age between 18 weeks and 23 weeks (18 0/7 to 22 6/7 weeks)

Exclusion Criteria

Higher order pregnancies

BMI > 40 at the start of pregnancy

Need for a second laser during pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo fetoscopic laser surgery with or without laparotomy suture placement

1 day

Follow-up

Participants are monitored for latency from surgery to delivery and other pregnancy outcomes

4 months

Treatment Details

Interventions

• Trans-Amniotic Suture Placement

Trial Overview The study is testing the effectiveness and safety of closing a laparotomy with trans-amniotic suture placement during TTTS surgery. It's a randomized trial, meaning patients will be randomly assigned to receive this specific closure technique or not.

Participant Groups

Group I: yes stitch (will receive a larger stitch from laparotomy) Experimental Treatment 1 Intervention

yes stitch for a larger stitch when receiving a laparotomy.

Group II: No stitch Active Control 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+