Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial (GMRT)

TriHealth

Status

Completed

Conditions

Circumcision, Male

Treatments

Device: Mogen Circumcision Clamp

Device: Gomco Circumcision Clamp

Study type

Interventional

Funder types

Other

Identifiers

NCT01726036

H-11121

Details and patient eligibility

About

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

Full 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.

Enrollment

274 patients

Sex

Male

Ages

Under 4 days old

Volunteers

Accepts Healthy Volunteers

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.