Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 2
- 主要终点
- Neonatal Salivary Cortisol Level
研究概览
简要总结
The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.
详细描述
Objective
To compare pain levels assessed by salivary cortisol and standardized neonatal pain scale among the two most common infant circumcision techniques in uncomplicated pregnancies after a thorough resident-wide education curriculum under attending physician supervision.
The secondary objectives are to assess the operative time, complication rates such as infection and bleeding and short term outcomes including need for re-circumcision among treatment groups.
Hypothesis
The Mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the Gomco technique after a resident circumcision standard teaching curriculum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 4 Days（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •term infants delivered by cesarean section or vaginal delivery at Good Samaritan Hospital during the time period of the study
- •Infants with no blood drawn two hours prior to the circumcision
- •Singletons
排除标准
- •Infants with congenital anomalies and/or known chromosomal syndromes
- •Preterm infants defined as less than 37 / 0 weeks gestation.
- •Delivery secondary to non-reassuring fetal heart tracing, defined by the delivering physician
- •Infants of diabetic mothers.
- •Infants of preeclamptic mothers on magnesium sulfate within 48 hours of delivery.
- •Infants delivered by vacuum-assisted or forceps-assisted vaginal delivery.
- •Infants of mothers who took steroids for fetal lung maturity within 7 days of delivery. (This may apply to term infants if the mother had no prenatal care and her gestational age was not known on arrival).
- •Infants with a 5 minutes apgar score of less than 7
- •Infants born to mothers with a history of drug abuse during pregnancy, currently on methadone, or with Hepatitis C or HIV.
研究组 & 干预措施
Gomco Circumcision Clamp
Gomco circumcision clamp used for neonatal circumcision.
干预措施: Gomco Circumcision Clamp (Device)
Mogen Circumcision Clamp
Mogen circumcision clamp used for neonatal circumcision.
干预措施: Mogen Circumcision Clamp (Device)
结局指标
主要结局
Neonatal Salivary Cortisol Level
时间窗: Approximately 2 hours before and 15 minutes after the procedure
Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure
Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool
时间窗: CRIES assessment completed prior to the procedure and post procedure.
The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.
次要结局
未报告次要终点