Clinical trial NCT06991400: Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Official title: Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Twin to Twin Transfusion Syndrome
Twin Anemia-Polycythemia Sequence
Keywords: fetoscopic surgery, laparotomy
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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) \[PMID: 28910784\].

Eligibility criteria: 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.

Primary outcomes:
measure: Latency from surgery to delivery
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.