Parents' Knowledge and Perception of Benefits and Risks Regarding Neonatal Circumcision

Circumcision Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909609
• Other study ID #: HUM00073478
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 16, 2017

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The American Academy of Pediatrics changed their stance on circumcision to "health benefits of newborn male circumcision outweigh the risks and that the procedure's benefits justify access to this procedure for families who choose it" (AAP, 2012).

We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to make this medical decision by weighing the risks against the benefits of circumcision, or do they simply use sociocultural/religious reasons to make this decision? We hypothesize that parents are unaware of the specific benefits and risks of circumcision, and make this decision based primarily on sociocultural, religious, and/or familial norms.

Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to accrue at least 680 participants for this study in order to achieve statistical significance and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will be encouraged to participate.

This survey will assess their desire to get their child circumcised when they are born. Participants will be asked to list perceived risks and benefits of circumcision. This will hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and benefits or circumcision, and what they perceive to be risky or beneficial from a medical standpoint.

Parents will be randomly given 1 of 2 pieces of information (1 per couple [or per single mother]; 1 control, 1 experiment) with different information about circumcision. We will see if there are any outcome differences based on which group the couple randomized into. Follow-up phone call will serve to assess outcome if baby was circumcised and any factors that led up to the decision. This will allow us to see if the AAP stance has any effect on decision making when we compare the control and experiment groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: June 16, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects will be recruited from the Obstetrics clinic. All expectant parents of children are eligible to participate in this study. The study team will include those who do not know the sex of their baby and later exclude those who ultimately have girls from the final survey.

Exclusion Criteria:

• Exclusion is limited to parents with a child that has had a genital anomaly identified via ultrasound before the time of the research study, and parents that definitively know they are having girls.

Related Conditions & MeSH terms

• Circumcision

Intervention

Other:
• AAP Documents

• Parent Survival Guide

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children circumcised		18 weeks