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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Adam Eickmeyer, University of Michigan
ClinicalTrials.gov Identifier:
NCT01909609
First received: July 24, 2013
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Circumcision
Other: AAP Documents
Other: Parent Survival Guide

Study Type: Interventional

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Number of children circumcised [ Time Frame: 18 weeks ]

Study Start Date: July 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Parent Survival Guide Other: Parent Survival Guide
Experimental: AAP Documents Other: AAP Documents

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909609

Contacts
Contact: Adam B Eickmeyer 734-232-9444 eickmeya@umich.edu
Contact: Julian Wan, M.D. 734-232-9444 juliwan@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Adam B Eickmeyer    734-232-9444    eickmeya@med.umich.edu   
Principal Investigator: Adam B Eickmeyer         
Sub-Investigator: Julian Wan, M.D.         
Sub-Investigator: Nina F Casanova, M.D.         
Sub-Investigator: Vesna Ivancic, M.D.         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Adam Eickmeyer, Research Assistant, University of Michigan
ClinicalTrials.gov Identifier: NCT01909609     History of Changes
Other Study ID Numbers: HUM00073478
Study First Received: July 24, 2013
Last Updated: July 25, 2013
Health Authority: United States: IRBMED University of Michigan

Keywords provided by University of Michigan:
male

ClinicalTrials.gov processed this record on September 18, 2014