Evaluation of Laparotomy With Trans-Amniotic Suture Placement in TTTS Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Latency from surgery to delivery
研究概览
简要总结
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.
详细描述
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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
yes stitch (will receive a larger stitch from laparotomy)
yes stitch for a larger stitch when receiving a laparotomy.
干预措施: Trans-Amniotic Suture Placement (Other)
No stitch
结局指标
主要结局
Latency from surgery to delivery
时间窗: 4 months
Will a transuterine suture placement cause later gestational age at delivery in babies with TTTs.
次要结局
未报告次要终点
研究者
Foong-Yen Lim
Surgical Director
Children's Hospital Medical Center, Cincinnati