Measurement of Individual Level of Abortion Stigma Study

Abortion Stigma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672605
• Other study ID #: 823273
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: July 29, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Abortion Stigma

Intervention

Other:
• Pennsylvania State Abortion Consent
Measuring the level of stigma felt pre- or post-exposure to the abortion consent language.

Locations

Country	Name	City	State
United States	Penn Family Planning and Pregnancy Loss Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual level stigma scores		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	No