Abortion StigmaNCT02672605
Measurement of Individual Level of Abortion Stigma Study
A study testing Pennsylvania State Abortion Consent in people with Abortion Stigma, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion Stigma
- What is being tested?
- Pennsylvania State Abortion Consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years old
- Seeking induced abortion for any indication
- Gestation ≤ 24 weeks
- Plan for procedural or state consent at current visit
- Willing and able to consent in English
Who cannot join
- Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language
- Have previously had an abortion
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Family Planning and Pregnancy Loss Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Abortion Stigma
- Being tested
- Pennsylvania State Abortion Consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pennsylvania State Abortion ConsentOther
Measuring the level of stigma felt pre- or post-exposure to the abortion consent language.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participant completes a survey measuring abortion stigma prior to receiving the mandatory Pennsylvania State consent for their abortion. |
| Investigational | Experimental | Participant completes a survey measuring abortion stigma after receiving the mandatory Pennsylvania State consent for their abortion. Receives: Other: Pennsylvania State Abortion Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual level stigma scores
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion StigmaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarita Sonalkar, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672605
- Sponsor's protocol ID
- 823273
- Status last verified
- Jul 2016
- First submitted
- 26 Jan 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Individual-Level Abortion Stigma Resulting From Pennsylvania State-Mandated Abortion Consent Language: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02672605
- Acronym / sponsor ID
- 823273
- Conditions
- Abortion Stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participant completes a survey measuring abortion stigma prior to receiving the mandatory Pennsylvania State consent for their abortion. |
| Investigational | Experimental | Other: Pennsylvania State Abortion ConsentParticipant completes a survey measuring abortion stigma after receiving the mandatory Pennsylvania State consent for their abortion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ≥18 years old
- Seeking induced abortion for any indication
- Gestation ≤ 24 weeks
- Plan for procedural or state consent at current visit
- Willing and able to consent in English
Key exclusion criteria (2 listed)
- Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language
- Have previously had an abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pennsylvania State Abortion ConsentMeasuring the level of stigma felt pre- or post-exposure to the abortion consent language. | Other | Investigational |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarita Sonalkar, MD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pennsylvania State Abortion Consent in people with Abortion Stigma, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.