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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01726036
Recruitment Status : Completed
First Posted : November 14, 2012
Results First Posted : May 16, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Circumcision, Male Device: Gomco Circumcision Clamp Device: Mogen Circumcision Clamp Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
Actual Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Active Comparator: Gomco Circumcision Clamp
Gomco circumcision clamp used for neonatal circumcision.
Device: Gomco Circumcision Clamp
Neonatal male circumcision utilizing the Gomco Circumcision Clamp

Active Comparator: Mogen Circumcision Clamp
Mogen circumcision clamp used for neonatal circumcision.
Device: Mogen Circumcision Clamp
Neonatal male circumcision utilizing the Mogen Circumcision Clamp




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726036


Locations
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United States, Ohio
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Mounira Habli, MD TriHealth Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT01726036    
Other Study ID Numbers: H-11121
First Posted: November 14, 2012    Key Record Dates
Results First Posted: May 16, 2019
Last Update Posted: June 5, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared by manuscript.
Keywords provided by TriHealth Inc.:
neonatal circumcision
neonatal surgical pain
Mogen
Gomco