RECRUITING

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

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Conditions

Twin to Twin Transfusion SyndromeTwin Anemia-Polycythemia Sequencefetoscopic surgery, laparotomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06991400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of TTTS or Twin Anemia-Polycythemia Sequence (TAPS)
  2. * Gestational age between 18 weeks and 23 weeks (18 0/7 to 22 6/7 weeks)
  3. * Cervical length \>2.5 cm preoperatively
  4. * Identification of a safe percutaneous surgical window by a provider experienced in fetoscopic surgery prior to entering the operating room
  1. * Higher order pregnancies, chromosomal or severe congenital anomalies, undergoing laser surgery for fetal growth restriction only, need for a second laser during pregnancy, failure to complete laser, PPROM prior to surgery. BMI\> 40 at the start of pregnancy, emergent case (i.e. surgery occurs \< 6 hours from presentation), significant fetal anomalies expected to drastically alter the risk of neonatal morbidity or mortality (i.e. anencephaly, cyanotic heart disease), or any significant maternal comorbidities as determined by physician i.e.: clotting disorders/blood disorders.

Contacts and Locations

Study Contact

Kimberly Richards
CONTACT
513-636-2310
kimberly.richards@cchmc.org
Erin Watters
CONTACT
513-803-7024
erin.watters@cchmc.org

Study Locations (Sites)

Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • fetoscopic surgery, laparotomy

Additional Relevant MeSH Terms

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