NCT02762773终止不适用
Does Avoiding Inferior Rectus Sheath Dissection Lead to Decreased Operative Blood Loss and Operating Time Without Increasing Delivery of Fetus in Primary Cesarean Delivery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- post-operative hemoglobin
研究概览
简要总结
The purpose of this study is to evaluate the effect of non-dissecting the inferior rectus sheath during primary cesarean delivery on post-operative hemoglobin and post-operative pain control as measured by VAS score and opioid anesthesia use in the first 72 hours post-op.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Patients must be 18 years or older as well as willing and able to provide informed consent
- •Patients undergoing a scheduled or non-scheduled, non-urgent or non-scheduled urgent (delivery within 30 minutes of decision for surgical delivery) Cesarean delivery between >35 weeks gestational age,
- •Patients who are expected to receive a Pfannenstiel incision
- •Patients with viable singleton intra-uterine pregnancy
- •Patients with fetus in cephalic presentation
排除标准
- •- Patients younger than 18 years,
- •Patients unable or unwilling to provide informed consent,
- •Patients who are illiterate,
- •Patients who are non-English speaking or reading,
- •Patients who are medical or nursing students at a school affiliated with University Hospital
- •Multi-fetal gestations (>1 intrauterine pregnancy),
- •Patients with a BMI >50 kg/m^2
- •Patients with a suspected placenta accreta or placenta previa
- •patients with 2 prior cesarean deliveries
- •Patient undergoing emergent cesarean delivery (delivery within 10 minutes of decision for surgical delivery)
- •Patients who will require a vertical skin incision, Maylard or Cherney incisions
- •Patients with a history of significant pelvic adhesive disease, as determined by prior operative reports
- •Patients with fetus in non-cephalic presentation
- •Patients with pre-gestational or gestational diabetes mellitus
- •Patients with estimated fetal weight >5000 grams
- •Patients with estimated fetal weight <10% for gestational age
- •Patients with who require general anesthetic
- •Patients who are on chronic pain medication
- •Patients with a history of drug abuse
结局指标
主要结局
post-operative hemoglobin
时间窗: 24 hours
assessment of drop in hemoglobin post-operatively compared to pre-operative values
次要结局
- assessment of Visual Analog Scale (VAS) scores in first 72 hours(72 hours)
- Assessment of total narcotic use, expressed as morphine equivalents(72 hours)
研究者
Emily Daggett
Principal Investigator
University Hospitals Cleveland Medical Center
研究点 (2)
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