Clinical trial NCT01726036: Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial
Official title: Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision, Male
Keywords: neonatal circumcision
neonatal surgical pain
Mogen
Gomco
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 274
Sex: MALE
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Neonatal Salivary Cortisol Level
timeFrame: Approximately 2 hours before and 15 minutes after the procedure
measure: Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool
timeFrame: CRIES assessment completed prior to the procedure and post procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Mounira Habli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinkey RG, Eschenbacher MA, Walsh PM, Doerger RG, Lambers DS, Sibai BM, Habli MA. The GoMo study: a randomized clinical trial assessing neonatal pain with Gomco vs Mogen clamp circumcision. Am J Obstet Gynecol. 2015 May;212(5):664.e1-8. doi: 10.1016/j.ajog.2015.03.029. Epub 2015 Mar 17.