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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01909609
First Posted: July 26, 2013
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adam Eickmeyer, University of Michigan
  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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other

Further study details as provided by Adam Eickmeyer, University of Michigan:

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

Estimated Enrollment: 680
Actual Study Start Date: July 2013
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: June 16, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Parent Survival Guide
This arm of the study will focus on the document that is normally given to all parents of newborn infants. It contains information on newborn care such as feeding, cleaning of the baby's penis, etc.
Other: Parent Survival Guide
Experimental: AAP Documents + Parent Survival Guide.
This arm of the study will focus on documents created based off of the American Academy of Pediatrics 2012 policy statement. They contain information on the potential risks and benefits of neonatal circumcision. The Parent Survival Guide contains information on newborn care such as feeding, cleaning of the baby's penis, etc.
Other: AAP Documents Other: Parent Survival Guide

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909609


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
  More Information

Responsible Party: Adam Eickmeyer, Research Assistant, University of Michigan
ClinicalTrials.gov Identifier: NCT01909609     History of Changes
Other Study ID Numbers: HUM00073478
First Submitted: July 24, 2013
First Posted: July 26, 2013
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by Adam Eickmeyer, University of Michigan:
male