NCT01726036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

May 16, 2019

Completed
Last Updated

June 5, 2019

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

November 1, 2012

Results QC Date

July 24, 2015

Last Update Submit

May 21, 2019

Conditions

Circumcision, Male

Keywords

neonatal circumcisionneonatal surgical painMogenGomco

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

Study Arms (2)

Gomco Circumcision Clamp

ACTIVE COMPARATOR

Gomco circumcision clamp used for neonatal circumcision.

Device: Gomco Circumcision Clamp

Mogen Circumcision Clamp

ACTIVE COMPARATOR

Mogen circumcision clamp used for neonatal circumcision.

Device: Mogen Circumcision Clamp

Interventions

Gomco Circumcision ClampDEVICE

Neonatal male circumcision utilizing the Gomco Circumcision Clamp

Gomco Circumcision Clamp
Mogen Circumcision ClampDEVICE

Neonatal male circumcision utilizing the Mogen Circumcision Clamp

Mogen Circumcision Clamp

Eligibility Criteria

AgeUp to 4 Days
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • Sinkey RG, Eschenbacher MA, Walsh PM, Doerger RG, Lambers DS, Sibai BM, Habli MA. The GoMo study: a randomized clinical trial assessing neonatal pain with Gomco vs Mogen clamp circumcision. Am J Obstet Gynecol. 2015 May;212(5):664.e1-8. doi: 10.1016/j.ajog.2015.03.029. Epub 2015 Mar 17.

    PMID: 25794628DERIVED

Results Point of Contact

Title
Rachel G. Sinkey MD - PI
Organization
TriHealth
pam_plummer@trihealth.com
513-862-6918

Study Officials

  • Mounira Habli, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 14, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

September 1, 2014

Last Updated

June 5, 2019

Results First Posted

May 16, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

The data will be shared by manuscript.

Locations

US(1)