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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01726036
Other study ID # H-11121
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2012
Est. completion date September 2014

Study information

Verified date January 2018
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date September 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A to 4 Days
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Gomco Circumcision Clamp
Neonatal male circumcision utilizing the Gomco Circumcision Clamp
Mogen Circumcision Clamp
Neonatal male circumcision utilizing the Mogen Circumcision Clamp

Locations

Country Name City State
United States TriHealth Good Samaritan Hospital Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neonatal Salivary Cortisol Level Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure Approximately 2 hours before and 15 minutes after the procedure
Primary Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool 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. CRIES assessment completed prior to the procedure and post procedure.
See also
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