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Recruiting

NCT Number: NCT06991400

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

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Braxton Forde

SUB_INVESTIGATOR

About this study

The rationale behind suturing the hole is that the amniotic membrane does not close itself, rather you are relying that the uterus closes over the hole in the amniotic membrane, which may or may not happen, as well as in fetoscopic surgery for another condition, myelomeningocele. Published data has shown that maternal laparotomy to suture closure of the port site at the time of fetoscopic surgery leads to improved pregnancy outcomes, later gestational age at delivery, and lower rates of preterm pre-labor rupture of membranes (PPROM) [PMID: 28910784].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Trans-Amniotic Suture Placement

Other

Trans-Amniotic Suture placement

Primary outcomes

  1. Latency from surgery to delivery

    Time frame: 4 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Watters

CONTACT

[email protected]

513-803-7024

Kimberly Richards

CONTACT

[email protected]

513-636-2310

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Acronym: TTTS TAPS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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