The Effect of Entry Technique on Chorioamniotic Membrane Separation in Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Rate of Immediate Chorioamniotic Membrane Separation (CAS)
研究概览
简要总结
The purpose of this study is to evaluate whether the entry technique surgeons use to get inside the uterus to perform fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome has an effect on the rates of chorioamniotic membrane separation.
详细描述
Patients who choose to undergo fetoscopic selective laser photocoagulation (SFLP) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and participants will be provided a copy of the signed consent.
After consent has been obtained, participants will be randomized into two groups ("direct entry" and "Seldinger technique").
Procedure: Selective laser photocoagulation (SFLP) is standard of care for the treatment of complicated monochorionic twin pregnancies. Entry into the uterus for SFLP is achieved under ultrasound guidance using one of two accepted methods, direct entry or the Seldinger technique. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure.
Group I - Direct entry: The surgeon will gain access to the uterus by inserting a sharp trocar through a small incision in the skin. After access has been established, the trocar is removed and a small tube called a cannula is left in place.
Group II - Seldinger technique: The surgeon will gain access to the uterus by inserting needle through a small incision in the skin and run a guide wire through the needle so a thin tube called a cannula can be placed over the wire.
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
- •Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome.
- •Patients will be between 16 0/7 weeks and 26 0/7 weeks gestational age.
排除标准
- •Patients who do not elect to undergo fetoscopic laser photocoagulation for the treatment of complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome.
- •Triplets and higher order multiple gestations.
- •Patients who are less than 16 0/7 weeks or greater than 26 0/7 weeks gestational age.
- •Patients with a short cervix (less than 1.5 cm).
- •Patients with a known subchorionic hemorrhage.
研究组 & 干预措施
Direct Entry
Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting a sharp trocar through a small incision in the skin. The trocar is then removed and a small tube called a cannula is left in place.
干预措施: Fetoscopic Laser Photocoagulation (Procedure)
Seldinger Technique
Surgeons will access the uterus to perform fetoscopic laser photocoagulation by inserting needle through a small incision in the skin and running a guide wire through the needle so a thin tube called a cannula can be placed over the wire.
干预措施: Fetoscopic Laser Photocoagulation (Procedure)
结局指标
主要结局
Rate of Immediate Chorioamniotic Membrane Separation (CAS)
时间窗: Up to hospital discharge post-procedure (up to 5 days)
Number of participants that have chorioamniotic membrane separation within 24 hours of the procedure.
次要结局
- Rate of Chorioamniotic Membrane Separation (CAS)(From the post-surgical period (outside the first 24 hours) until delivery, up to 25 weeks)
- Gestational Age at Delivery(At delivery)
- Preterm Birth(At delivery)
- Procedure to Delivery Interval(At delivery)
- Placental Abruption(Up to hospital discharge post-procedure (up to 5 days))
- Chorioamnionitis(Up to hospital discharge post-procedure (up to 5 days))
- Septostomy(Up to hospital discharge post-procedure (up to 5 days))
- Preterm Premature Rupture of Membranes (PPROM)(At delivery)
研究者
Ahmed Nassr
Associate Professor
Baylor College of Medicine
