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Measurement of Individual Level of Abortion Stigma Study

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.
 
ClinicalTrials.gov Identifier: NCT02672605
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study is a randomized controlled trial designed to measure abortion stigma related to the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive the validated Individual Level Abortion Stigma Scale either before or after consent via the Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in the two groups.

Condition or disease Intervention/treatment Phase
Abortion Stigma Other: Pennsylvania State Abortion Consent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Measurement of Individual-Level Abortion Stigma Resulting From Pennsylvania State-Mandated Abortion Consent Language: A Pilot Randomized Controlled Trial
Study Start Date : November 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
No Intervention: Control
Participant completes a survey measuring abortion stigma prior to receiving the mandatory Pennsylvania State consent for their abortion.
Experimental: Investigational
Participant completes a survey measuring abortion stigma after receiving the mandatory Pennsylvania State consent for their abortion.
Other: Pennsylvania State Abortion Consent
Measuring the level of stigma felt pre- or post-exposure to the abortion consent language.




Primary Outcome Measures :
  1. Individual level stigma scores [ Time Frame: Stigma store is collected during one 30-minute study visit, either directly prior or directly following the patient being consented using the PA Abortion Control Act language ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women ≥18 years old
  2. Seeking induced abortion for any indication
  3. Gestation ≤ 24 weeks
  4. Plan for procedural or state consent at current visit
  5. Willing and able to consent in English

Exclusion Criteria:

  1. Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language
  2. Have previously had an abortion

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): NCT02672605


Locations
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United States, Pennsylvania
Penn Family Planning and Pregnancy Loss Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Sarita Sonalkar, MD, MPH University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02672605    
Other Study ID Numbers: 823273
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No