Neonatal Male Circumcision Clinical Trial
Official title:
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.
The objective was to assess the acceptability and safety of neonatal male circumcision
performed by clinical officers (equivalent to US physician assistants) and nurse midwives,
using the Mogen clamp.
This was a randomized, blinded trial of circumcision using the Mogen clamp under topical
anesthesia in healthy male infants aged 1-28 days, with normal birth weight and gestational
age, performed by trained clinical officers or nurse midwives, randomized 1:1 in Rakai
District, Uganda.
Mothers of male infants born in 4 health centers were invited to participate and signed an
informed consent for screening and enrollment. Infants were screened on enrollment prior to
randomization (1;1) to clinical officer and nurse midwife circumcision providers.
Follow up was via a phone call at 24 hours, 7 days and 4 weeks post-circumcision.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01115335 -
Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
|
Phase 4 |