Pregnancy Termination in First TrimesterPACNCT03030443
Patient Preferences in Anesthesia for Abortion Care
An observational study of Pregnancy Termination in First Trimester, run by University of New Mexico at 1 site in United States.
Trial summary
This study will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Termination in First Trimester
- Type of treatment
- Pill or oral medicine
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 23 Feb 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing first trimester surgical abortion choosing between oral anesthesia and nitrous oxide. All patients will be English-speaking women who are 18 years old or older.
Who may be able to join
- women undergoing first trimester surgical abortion choosing between oral anesthesia or nitrous oxide for pain management
- women who are able to read and understand English
- women who are 18 years old or older
Who cannot join
- under the age of 18
- women unable to consent and/or are cognitively impaired
- women who are incarcerated
- women who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
This study will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. We will analyze two study cohorts of women undergoing first trimester surgical abortion: women choosing oral anesthesia and women choosing nitrous oxide.
Read the detailed description
This study will utilize an open-ended semi-structured interview format to elicit a broader understanding of the multi-dimensional pain experience of woman undergoing an abortion procedure. This study seeks to provide further evaluation of the pain experience and preferences of women receiving alternative methods of pain management such as oral sedation and nitrous oxide.
The study will use semi-structured interviews to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion and will include a procedural pain outcome using the visual analog scale (VAS) to create a more patient centered experience.
- Conditions
- Pregnancy Termination in First Trimester
- Keywords
- Pain management, Nitrous
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral Sedation | Patients in this group will receive a standard procedure first trimester abortion using oral sedation for pain management following the clinic's protocol. Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion. | |
| Nitrous Oxide | Patients in this group will receive a standard procedure first trimester abortion using titrated nitrous oxide for pain management following the clinic's protocol. Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Patient Priorities and Preferences for pain and pain management through Qualitative Analysis
To identify patient priorities and preferences for pain and pain management using Qualitative Analysis prior to their first trimester surgical abortion under local anesthesia with oral or nitrous oxide sedation.
Measured: through patient completion in study, up to one week following the procedure
Secondary outcomes (1)
Compare quantitative and qualitative assessment of pain
Compare the quantitative objective assessment of maximum procedural pain using the visual analog scale (VAS) with the qualitative assessment of pain obtained via semi-structured interviews.
Measured: through patient completion in study, up to one week following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start4 Apr 2017
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Termination in First TrimesterStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Rameet Singh, University of New Mexico
- Investigators
- Rameet Singh, MD, MPH, Principal investigator, University of New Mexico Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030443
- Sponsor's protocol ID
- 16-275
- Acronym
- PAC
- Status last verified
- May 2023
- First submitted
- 10 Jan 2017
- Last updated
- 31 May 2023
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences in Anesthesia for Abortion Care
- ClinicalTrials.gov ID
- NCT03030443
- Acronym / sponsor ID
- PAC / 16-275
- Conditions
- Pregnancy Termination in First Trimester
- Keywords
- Pain management, Nitrous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 25 Jan 2017 (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 will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. We will analyze two study cohorts of women undergoing first trimester surgical abortion: women choosing oral anesthesia and women choosing nitrous oxide.
Detailed description
This study will utilize an open-ended semi-structured interview format to elicit a broader understanding of the multi-dimensional pain experience of woman undergoing an abortion procedure. This study seeks to provide further evaluation of the pain experience and preferences of women receiving alternative methods of pain management such as oral sedation and nitrous oxide.
The study will use semi-structured interviews to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion and will include a procedural pain outcome using the visual analog scale (VAS) to create a more patient centered experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Sedation | – | –Patients in this group will receive a standard procedure first trimester abortion using oral sedation for pain management following the clinic's protocol. Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion. |
| Nitrous Oxide | – | –Patients in this group will receive a standard procedure first trimester abortion using titrated nitrous oxide for pain management following the clinic's protocol. Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing first trimester surgical abortion choosing between oral anesthesia and nitrous oxide. All patients will be English-speaking women who are 18 years old or older.
Key inclusion criteria (3 listed)
- women undergoing first trimester surgical abortion choosing between oral anesthesia or nitrous oxide for pain management
- women who are able to read and understand English
- women who are 18 years old or older
Key exclusion criteria (4 listed)
- under the age of 18
- women unable to consent and/or are cognitively impaired
- women who are incarcerated
- women who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify Patient Priorities and Preferences for pain and pain management through Qualitative Analysis
Time frame: through patient completion in study, up to one week following the procedure
To identify patient priorities and preferences for pain and pain management using Qualitative Analysis prior to their first trimester surgical abortion under local anesthesia with oral or nitrous oxide sedation.
1 secondary outcome
Compare quantitative and qualitative assessment of pain
Time frame: through patient completion in study, up to one week following the procedure
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 31 May 2023.
- 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.
Rameet Singh, MD, MPH principal investigator
University of New Mexico Health Sciences Center
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 in First Trimester, 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 3 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 31 May 2023. 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?
Identify Patient Priorities and Preferences for pain and pain management through Qualitative Analysis (time frame: through patient completion in study, up to one week following the procedure). 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 31 May 2023.