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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 501
- 主要终点
- Adverse events related to circumcision
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age 1-28 days
- •birth weight >= 2,500 gm
- •gestational age >=37 weeks
- •no illness. normal temperature
- •no genital anatomic abnormality
排除标准
- •age >28 days
- •birth weight <2,500 gm
- •gestational age <37 weeks
- •Ill health
- •genital abnormality
结局指标
主要结局
Adverse events related to circumcision
时间窗: 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
时间窗: through study completion, an of 1 year
Proportion of registered mother-child pairs in which the male infant was circumcised
Wound healing
时间窗: 4 weeks
Completed wound healing (clean intact scar without a scab or stitch sinus)
次要结局
- Procedure time(Less than 15 minutes)
- Parental satisfaction(4 weeks)
- Neonatal pain scale (NIPS)(During surgery)
研究者
Ronald Gray
Professor
Johns Hopkins Bloomberg School of Public Health