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A Randomized Trial of the Acceptability and Safety of Early Infant Male Circumcision (EIMC) Conducted by Nurse Midwives and Clinical Offices Using the Mogen Clamp
Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and Southern African countries, and the long-term sustainability of MMC programs could best be achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of EIMC provided by non-physicians is unknown. Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda. 501 healthy neonates aged 1-28 days with normal birth weight and gestational age were randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days. Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local Anesthetics (EMLA) cream and a 24% sucrose solution.
Details
| Lead sponsor | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 501 |
| Start date | 2014-10 |
| Completion | 2015-07 |
Conditions
- Neonatal Male Circumcision
Interventions
- Neonatal circumcision under topical anesthesia
Primary outcomes
- Adverse events related to circumcision — 4 weeks
Adverse events graded as mild, moderate and severe - Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trial — through study completion, an of 1 year
Proportion of registered mother-child pairs in which the male infant was circumcised - Wound healing — 4 weeks
Completed wound healing (clean intact scar without a scab or stitch sinus)