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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01726036 |
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Date of registration:
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01/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial
GMRT |
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Scientific title:
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Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study. |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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274 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01726036 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Mounira Habli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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TriHealth Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
4 Days
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Circumcision, Male
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Intervention(s)
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Device: Gomco Circumcision Clamp
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Device: Mogen Circumcision Clamp
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Primary Outcome(s)
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Neonatal Salivary Cortisol Level
[Time Frame: Approximately 2 hours before and 15 minutes after the procedure]
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Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool
[Time Frame: CRIES assessment completed prior to the procedure and post procedure.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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