A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 753
- 试验地点
- 3
- 主要终点
- Adhesion Score
研究概览
简要总结
A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).
详细描述
Patients presenting to labor and delivery for delivery will be screened for eligibility. If a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. After the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. At this point, she will be considered a candidate for randomization.
If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:
- Group A - Placement of Seprafilm® prior to abdominal closure
- Group B - Routine closure without placement of Seprafilm® The chances of being assigned to either group will be equal (i.e., 1:1 randomization). The patient will be blinded with regard to Seprafilm placement.
The investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. There are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. Enrollment in this study is not expected to alter the patient's length of stay.
The antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. This study in no way changes or directs the care the patient would receive, except with regard to the placement of Seprafilm® Adhesion Barrier.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who are planning or have the potential to undergo cesarean delivery
- •Age over 18
- •Able to consent to study
排除标准
- •Planned tubal ligation
- •Known allergy to hyaluronic acid
- •Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol
研究组 & 干预措施
HA-CMC Group
Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier
干预措施: modified sodium hyaluronic acid and carboxymethylcellulose (Device)
Routine Closure Group
Routine Closure without placement of an adhesion barrier
干预措施: Placebo (Device)
结局指标
主要结局
Adhesion Score
时间窗: 3 to 5 years
Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).
Incidence of Adhesions
时间窗: 3 to 5 years
The Percentage of participants with one or more adhesions, regardless of the extent or severity
次要结局
- Post-operative Hemoglobin(1 to 5 years)
- Post-operative White Blood Cell Count(1 to 5 years)
- Post-Operative Complications(1 to 5 years)
- Post-operative Maximum Temperature Following Randomization(1 to 5 years)
- Operative Times at Subsequent Delivery(3 to 5 years)
研究者
Daniel Kiefer
Principal Investigator
Winthrop University Hospital