The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure - a Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Collection and reapplication of autologous amniotic fluid
研究概览
简要总结
The purpose of this study is to determine the feasibility of collecting amniotic fluid at delivery that will be immediately processed and then applied as a spray to the various layers of cesarean wound closure.
详细描述
This is a single-site, prospective pilot study involving the collection of amniotic fluid at cesarean delivery followed by the immediate processing and re-application to the closure among twenty women at term undergoing cesarean delivery at Duke University Hospital. The objective of the study is to determine the feasibility of collection and application of autologous amniotic fluid at cesarean delivery.
VISIT 1: Screening/Enrollment Visit:
Once informed consent is obtained, demographic information, as well as medical and surgical history will be obtained. A medical release form will also be signed so that in the event that the subject is seen outside the Duke Health system after delivery, the study team will be able to request pertinent medical records.
VISIT 2: Day of Surgery Visit:
At presentation for delivery, study team members will reconfirm eligibility criteria. Subjects will then undergo cesarean delivery as per standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Pregnant female age great than 18 years
- •Singleton gestation
- •Plan for cesarean delivery
- •Planned gestational age of at least weeks at the time of delivery
- •English speaking
- •Able to provide own informed consent
- •Intention of being available for entire study period and complete all relevant study procedures, including follow-up study visits and phone calls
- •Exclusion criteria at screening/enrollment:
- •Diabetes requiring therapy (type I or type II diabetes, gestational diabetes on medical therapy)
- •BMI greater than or equal to 40 kg/m2 at the time of enrollment
- •Placenta previa or placenta accreta
- •Prior bowel or urologic surgery (except un-ruptured appendectomy or uncomplicated cholecystectomy)
- •Multiple gestation
- •Previous history of postpartum hemorrhage requiring medical or surgical treatment
- •Known or suspected impairment of immunologic function including infection with HIV, hepatitis B or C
- •Known tobacco or drug use
- •Any condition which, in the opinion of the investigator, may pose a health risk to the subject or interfere with the evaluation of the study objectives
- •History of keloid formation
- •Exclusion criteria at time of surgery:
- •Labor at time of presentation to labor and delivery (regular, painful uterine contractions occurring every 5 minutes with evidence of cervical change)
- •Chorioamnionitis or other systemic infection at time of presentation for cesarean section, including evidence of lower abdominal skin infection (i.e. yeast, etc)
- •Need for urgent Cesarean section (examples include, but not limited to: non-reassuring fetal status (category II or III tracing), placental abruption, severe preeclampsia or eclampsia)
- •Rupture of membranes prior to the start of the surgery
- •Meconium-stained or blood-stained amniotic fluid
- •Experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC), or other medical or surgical condition during the delivery deemed by the investigator to pose a prohibitively high risk for surgical re-exploration or wound complication.
- •Who, in the investigator's opinion, would have any clinically significant condition that would impair the patient's ability to comply with the study procedures
- •Need for vertical skin incision
- •Intraoperative use of hemostatic agent (examples include FLOSEAL and AVIGUARD®)
- •Plan for use of staples at closure of the skin incision
- •Preeclampsia with severe features
排除标准
- 未提供
结局指标
主要结局
Collection and reapplication of autologous amniotic fluid
时间窗: At time of delivery
Feasibility of collection and reapplication of autologous amniotic fluid at the time of a cesarean delivery
次要结局
- Cesarean Wound Complication(6 weeks)
- Pain Medication Use(4 and 6 weeks)
- Assessment of the Cesarean Wound(4 weeks)
- Pain Score(4 and 6 weeks)