N/A N=274 Randomized Single-blind Other

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

Circumcision, Male

Bottom Line

View on ClinicalTrials.gov: NCT01726036 ↗

Enrolled (actual)

274

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Neonatal Salivary Cortisol Level — 0.63; 0.72; 1.14; 1.08 mcg/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Gomco Circumcision Clamp (Device); Mogen Circumcision Clamp (Device)
Age: Pediatric
Sex: Male
Sponsor: TriHealth Inc.
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Neonatal Salivary Cortisol Level	0.63; 0.72; 1.14; 1.08	—
PRIMARY Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool	2; 2	0.457

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.

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.

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Data sourced from ClinicalTrials.gov (NCT01726036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.