Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06991400
Status
Recruiting
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Conditions

  • Twin Anemia-Polycythemia Sequence
  • Twin to Twin Transfusion Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trans-Amniotic Suture Placement — OTHER
    Trans-Amniotic Suture placement

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
May 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: yes stitch (will receive a larger stitch from laparotomy)
    yes stitch for a larger stitch when receiving a laparotomy.
  • No Intervention: No stitch

Primary Outcome Measure

Latency from surgery to delivery [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229
Braxton Forde (SUB_INVESTIGATOR)

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By research site
Cincinnati Childrens Hospital Medical Center· Cincinnati, OH

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