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

NCT06991400 | Recruiting DMC

• 1 other identifier: 2024-0006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Twin to Twin Transfusion Syndrome; Twin Anemia-Polycythemia Sequence

Keywords

fetoscopic surgery, laparotomy

Outcome Measures

Primary Outcomes (1)

• Latency from surgery to delivery

  Will a transuterine suture placement cause later gestational age at delivery in babies with TTTs.

  4 months

Study Arms (2)

yes stitch (will receive a larger stitch from laparotomy)

EXPERIMENTAL

yes stitch for a larger stitch when receiving a laparotomy.

Other: Trans-Amniotic Suture Placement

No stitch

NO INTERVENTION

Interventions

Trans-Amniotic Suture Placement OTHER

Trans-Amniotic Suture placement

yes stitch (will receive a larger stitch from laparotomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of TTTS or Twin Anemia-Polycythemia Sequence (TAPS)
• Gestational age between 18 weeks and 23 weeks (18 0/7 to 22 6/7 weeks)
• Cervical length \>2.5 cm preoperatively
• Identification of a safe percutaneous surgical window by a provider experienced in fetoscopic surgery prior to entering the operating room

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Publications (2)

• Forde B, Sepulveda Gonzalez G, Lim FY, Arroyo-Lemarroy T, Nava Geurrero EN, Lizarraga-Cepeda E, Habli M, McKinney D, Hoffman M, Peiro JL. Should We Stitch-Close the Fetoscopic Percutaneous Access? A Case-Series of Laparotomy to Trans-Amniotic Membrane Suturing for Intrauterine Port Placement in Fetoscopic Surgery for Twins. Fetal Diagn Ther. 2024;51(5):510-515. doi: 10.1159/000539894. Epub 2024 Jun 18.

  PMID: 38889699 BACKGROUND

• Kabagambe SK, Jensen GW, Chen YJ, Vanover MA, Farmer DL. Fetal Surgery for Myelomeningocele: A Systematic Review and Meta-Analysis of Outcomes in Fetoscopic versus Open Repair. Fetal Diagn Ther. 2018;43(3):161-174. doi: 10.1159/000479505. Epub 2017 Sep 15.

  PMID: 28910784 BACKGROUND

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Kimberly Richards

CONTACT

513-636-2310; kimberly.richards@cchmc.org

Erin Watters

CONTACT

513-803-7024; erin.watters@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Director

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: May 28, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)