Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Latency from surgery to delivery
Study Overview
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].
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
yes stitch (will receive a larger stitch from laparotomy)
yes stitch for a larger stitch when receiving a laparotomy.
Intervention: Trans-Amniotic Suture Placement (Other)
No stitch
Outcomes
Primary Outcomes
Latency from surgery to delivery
Time Frame: 4 months
Will a transuterine suture placement cause later gestational age at delivery in babies with TTTs.
Secondary Outcomes
No secondary outcomes reported
Investigators
Foong-Yen Lim
Surgical Director
Children's Hospital Medical Center, Cincinnati