Measurement of Individual Level of Abortion Stigma Study

July 29, 2016 updated by: University of Pennsylvania

Measurement of Individual-Level Abortion Stigma Resulting From Pennsylvania State-Mandated Abortion Consent Language: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Family Planning and Pregnancy Loss Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Sarita Sonalkar, MD, MPH, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 29, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 823273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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