Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trans-Amniotic Suture Placement.
- Who it may be relevant to
- Registry conditions: Twin to Twin Transfusion Syndrome, Twin Anemia-Polycythemia Sequence. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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) \[PMID: 28910784\].
Interventions
- Other Trans-Amniotic Suture Placement
Trans-Amniotic Suture placement
Primary outcome measures
- Latency from surgery to delivery [Time frame: 4 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cincinnati Childrens Hospital Medical Center — Cincinnati
Publications
- 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 Ju PMID 38889699
- 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
Identifiers
NCT: NCT06991400 · 2024-0006