ContraceptionNCT01807715
Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion
An observational study of Contraception and Abortion, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. The investigators will ask the staff at each facility to offer a survey to all women 18 and older presenting to the clinic to have a first trimester (<12 weeks gestation) surgical abortion. 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
- Contraception, Abortion
- What is being tested?
- survey
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 2013
- 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 seeking first trimester surgical abortion
Who may be able to join
- seeking first trimester surgical abortion
Who cannot join
- Women who cannot understand or read the survey
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
The investigators will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. The investigators will ask the staff at each facility to offer a survey to all women 18 and older presenting to the clinic to have a first trimester (<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. The investigators hope to implement the survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a target population of 600 women receiving surgical first trimester abortions at these two clinics over a 3-4 month period with a 95% confidence interval).
Read the detailed description
We will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. We will introduce the research project to clinic staff, recruiting their support and participation, as they will be the main implementers. The survey will be offered to women in the waiting room before any pre-procedure counseling. We will include all women presenting to the clinic who are 18 years and older and planning to have a first trimester (<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. We hope to implement the survey at these two clinics for 3-4 months reaching a minimum of 200 women so as to obtain an adequate power for our study. The brief survey will include a cover letter explaining the study and stressing the anonymity and confidentiality. The surveys will include an envelope in which to place completed surveys; the envelope can be sealed by the participant and dropped in a collection bin. This process will allow the data to be collected anonymously. The survey data will then be synthesized first by descriptive analysis, followed by chi-square and multiple regression analyses. A statistician in the University of California Davis Department of Obstetrics and Gynecology will help when necessary.
- Conditions
- Contraception, Abortion
- Being tested
- survey
- Keywords
- first trimester, surgical abortion, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
Survey before procedure to obtain demographic information and contraceptive information
| Study group | Role | What they receive |
|---|---|---|
| Study group | Women seeking first trimester surgical abortion Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient preference
patient preference for whether she wants to discuss contraception during her visit for an abortion
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell D Creinin, MD, Study director, UC DavisMelissa Matulich, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807715
- Sponsor's protocol ID
- 352286
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2013
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Matulich M, Cansino C, Culwell KR, Creinin MD. Understanding women's desires for contraceptive counseling at the time of first-trimester surgical abortion. Contraception. 2014 Jan;89(1):36-41. doi: 10.1016/j.contraception.2013.09.013. Epub 2013 Sep 30.
PubMed 24161475
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Women's Contraceptive Expectations at the Time of a First Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT01807715
- Acronym / sponsor ID
- 352286
- Conditions
- Contraception, Abortion
- Keywords
- first trimester, surgical abortion, contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Mar 2013 (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 investigators will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. The investigators will ask the staff at each facility to offer a survey to all women 18 and older presenting to the clinic to have a first trimester (<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. The investigators hope to implement the survey at these clinics for 3-4 months reaching a minimum of 200 women (based on a target population of 600 women receiving surgical first trimester abortions at these two clinics over a 3-4 month period with a 95% confidence interval).
Detailed description
We will conduct a voluntary anonymous survey at four separate Sacramento area family planning clinics. We will introduce the research project to clinic staff, recruiting their support and participation, as they will be the main implementers. The survey will be offered to women in the waiting room before any pre-procedure counseling. We will include all women presenting to the clinic who are 18 years and older and planning to have a first trimester (<12 weeks gestation) surgical abortion. Gestational age will be based on what the woman believes is her gestational age at presentation, before any evaluation in the clinic. Women who cannot understand or read the survey will be excluded. We hope to implement the survey at these two clinics for 3-4 months reaching a minimum of 200 women so as to obtain an adequate power for our study. The brief survey will include a cover letter explaining the study and stressing the anonymity and confidentiality. The surveys will include an envelope in which to place completed surveys; the envelope can be sealed by the participant and dropped in a collection bin. This process will allow the data to be collected anonymously. The survey data will then be synthesized first by descriptive analysis, followed by chi-square and multiple regression analyses. A statistician in the University of California Davis Department of Obstetrics and Gynecology will help when necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: surveyWomen seeking first trimester surgical abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women seeking first trimester surgical abortion
Key inclusion criteria (1 listed)
- seeking first trimester surgical abortion
Key exclusion criteria (1 listed)
- Women who cannot understand or read the survey
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 |
|---|---|---|
| surveySurvey before procedure to obtain demographic information and contraceptive information | Other | Study group |
Primary outcome
patient preference
Time frame: one day
patient preference for whether she wants to discuss contraception during her visit for an abortion
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 18 Apr 2023.
- Results publication: PubMed 24161475Matulich M, Cansino C, Culwell KR, Creinin MD. Understanding women's desires for contraceptive counseling at the time of first-trimester surgical abortion. Contraception. 2014 Jan;89(1):36-41. doi: 10.1016/j.contraception.2013.09.013. Epub 2013 Sep 30.
- Journal page with articleLink provided by the sponsor.
- 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.
Mitchell D Creinin, MD study director
UC Davis
Melissa Matulich principal investigator
UC Davis
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 Contraception and Abortion, run by University of California, Davis 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 1 inclusion and 1 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 18 Apr 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?
patient preference (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807715, which also lists 1 linked publication.
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 18 Apr 2023.