Pregnancy TerminationNCT02827474
We Experience: Perspectives on a Quality Abortion Care Experience: A Patient Centered Approach
An observational study of Pregnancy Termination, run by University of New Mexico at 1 site in United States.
Trial summary
The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients'… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Termination
- What is being tested?
- Patient Interview and Provider Interview
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 20 Jan 2018
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patient Participants: Women presenting to Center for Reproductive Health (CRH) for induced abortion for an undesired pregnancy in the first trimester < 14 weeks and age 18-45 years. Woman must have a completed surgical abortion procedure and be able to speak English or Spanish. Provider Participants: Providers must be performing procedures on the day patient participants are recruited and must be willing to give their perspective on the participating patients' abortion experience.
Who may be able to join
- Women presenting to the Center for Reproductive Health (CRH) for induced abortion for an undesired pregnancy in the first trimester < 14 weeks.
- Women ages 18-45 years.
- Woman must have a completed surgical abortion procedure
- Women must be able to speak English or Spanish.
Who cannot join
- Women who are unable or unwilling to consent for the study or are unable or unwilling to complete a follow-up interview
- Women who are unable to consent and/or are cognitively impaired.
- Women who are under the age of 18
- Women who are incarcerated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Reproductive Health
Albuquerque, New Mexico, 87106
About this study
Official title: Perspectives on a Quality Abortion Care Experience: A Patient Centered Approach
The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.
Read the detailed description
The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.
The investigators will conduct semi-structured interviews with patient participants and providers separately to determine patients' expectations of abortion care as well as the most important aspects of the abortion experience and to explore providers' perceptions of their patients' abortion experience and assess concordance.
- Conditions
- Pregnancy Termination
- Being tested
- Patient Interview, Provider Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient InterviewOther
Patient intervention includes a 30 minute interview prior to their abortion procedure and a follow up phone-interview that will be 10-minutes and held 24-72 hours from the procedure.
Provider InterviewOther
For physician participants, providers will be interviewed after completion of the patient's visit and this will be 10-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patient Participants | Patient participants will participate in two patient interviews. Receives: Other: Patient Interview | |
| Physician Participants | Provider participants will participate in one provider interview. Receives: Other: Provider Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience, semi-structured interviews
The investigators will use semi-structured interviews to determine aspects of abortion care most important to the patients in creating a "high quality" abortion experience.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion20 Jan 2018
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy TerminationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Pereda, University of New Mexico
- Investigators
- Brenda Pereda, MD, Principal investigator, University on New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827474
- Sponsor's protocol ID
- UNMHSC- 16-111
- Status last verified
- Feb 2018
- First submitted
- 1 Jul 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives on a Quality Abortion Care Experience: A Patient Centered Approach
- ClinicalTrials.gov ID
- NCT02827474
- Acronym / sponsor ID
- UNMHSC- 16-111
- Conditions
- Pregnancy Termination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 11 Jul 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.
The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.
Detailed description
The purpose of this study is to determine aspects of abortion care most important to the patient in creating a "high quality" abortion experience, to investigate patients' expectations of abortion care, and to explore provider perceptions of patients' abortion experiences and assess concordance with patients' perspectives.
The investigators will conduct semi-structured interviews with patient participants and providers separately to determine patients' expectations of abortion care as well as the most important aspects of the abortion experience and to explore providers' perceptions of their patients' abortion experience and assess concordance.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Participants | – | Other: Patient InterviewPatient participants will participate in two patient interviews. |
| Physician Participants | – | Other: Provider InterviewProvider participants will participate in one provider interview. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient Participants: Women presenting to Center for Reproductive Health (CRH) for induced abortion for an undesired pregnancy in the first trimester < 14 weeks and age 18-45 years. Woman must have a completed surgical abortion procedure and be able to speak English or Spanish. Provider Participants: Providers must be performing procedures on the day patient participants are recruited and must be willing to give their perspective on the participating patients' abortion experience.
Key inclusion criteria (4 listed)
- Women presenting to the Center for Reproductive Health (CRH) for induced abortion for an undesired pregnancy in the first trimester < 14 weeks.
- Women ages 18-45 years.
- Woman must have a completed surgical abortion procedure
- Women must be able to speak English or Spanish.
Key exclusion criteria (4 listed)
- Women who are unable or unwilling to consent for the study or are unable or unwilling to complete a follow-up interview
- Women who are unable to consent and/or are cognitively impaired.
- Women who are under the age of 18
- Women who are incarcerated.
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 |
|---|---|---|
| Patient InterviewPatient intervention includes a 30 minute interview prior to their abortion procedure and a follow up phone-interview that will be 10-minutes and held 24-72 hours from the procedure. | Other | Patient Participants |
| Provider InterviewFor physician participants, providers will be interviewed after completion of the patient's visit and this will be 10-15 minutes. | Other | Physician Participants |
Primary outcome
Patient Experience, semi-structured interviews
Time frame: One year
The investigators will use semi-structured interviews to determine aspects of abortion care most important to the patients in creating a "high quality" abortion experience.
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 15 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Brenda Pereda, MD principal investigator
University on New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Termination, run by University of New Mexico 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 4 inclusion and 4 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 15 Feb 2018. 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?
Patient Experience, semi-structured interviews (time frame: One year). 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 15 Feb 2018.