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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01726036
First received: November 1, 2012
Last updated: March 13, 2014
Last verified: March 2014

November 1, 2012
March 13, 2014
October 2012
March 2014   (final data collection date for primary outcome measure)
Neonatal pain [ Time Frame: Approximately 2 hours before and 15 minutes after the procedure ] [ Designated as safety issue: Yes ]
Neonatal pain will be assessed by change in salivary cortisol level pre and post procedure
Same as current
Complete list of historical versions of study NCT01726036 on ClinicalTrials.gov Archive Site
  • Bleeding [ Time Frame: Approximately 10 minutes after the procedure ] [ Designated as safety issue: Yes ]
    Bleeding is measured by weight of blood soaked gauzes after the procedure
  • Procedural Time [ Time Frame: Participants will be followed for the duration of procedure, average 4 minutes ] [ Designated as safety issue: Yes ]
    Time needed to complete the circumcision:start time from local anesthesia to end of circumcision.
  • Parental satisfaction [ Time Frame: Approximately 6 weeks after the procedure ] [ Designated as safety issue: No ]
    Approximately 6 weeks after the procedure parental satisfaction will be assessed by a phone survey.
  • Need for circumcision revision [ Time Frame: Approximately 6 weeks after the circumcision ] [ Designated as safety issue: Yes ]
    Approximately 6 weeks after the procedure the pediatrician's office will be contacted to see if a circumcision revision was needed.
  • Postoperative infection [ Time Frame: Approximately 6 weeks after circumcision ] [ Designated as safety issue: Yes ]
    Approximately 6 weeks after the circumcision the pediatrician's office will be contacted regarding surgical site infection.
Same as current
Neonatal pain score [ Time Frame: Assesed from time of recruitment to end of procedure, approximately 1 day. ] [ Designated as safety issue: Yes ]
Standardized score including vital signs and facial expression
Same as current
 
Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial
Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Neonatal Circumcision
  • Device: Gomco Circumcision Clamp
  • Device: Mogen Circumcision Clamp
  • Active Comparator: Gomco Circumcision Clamp
    Gomco circumcision clamp used for neonatal circumcision.
    Intervention: Device: Gomco Circumcision Clamp
  • Active Comparator: Mogen Circumcision Clamp
    Mogen circumcision clamp used for neonatal circumcision.
    Intervention: Device: Mogen Circumcision Clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
274
June 2014
March 2014   (final data collection date for primary outcome measure)

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.
Male
up to 4 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01726036
H-11121
No
TriHealth Inc.
TriHealth Inc.
Not Provided
Not Provided
TriHealth Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP