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Completed

NCT Number: NCT01726036

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

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

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Key information

Conditions

Age range

Up to 4 day

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gomco Circumcision Clamp

Device

Neonatal male circumcision utilizing the Gomco Circumcision Clamp

Mogen Circumcision Clamp

Device

Neonatal male circumcision utilizing the Mogen Circumcision Clamp

Primary outcomes

  1. Neonatal Salivary Cortisol Level

    Time frame: 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

  2. Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.

Acronym: GMRT

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2012
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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