ContraceptionPPRNCT01199952
RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion?
A study testing Treatment group: receives counseling phone call intervention in people with Contraception, run by University of California, San Francisco at 1 site in United States.
Trial summary
Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group. Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Treatment group: receives counseling phone call intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women over the age of 15 who choose pill, patch or ring to begin after their abortion
- Women able and willing to be contacted by phone for up to 2 months after enrollment
Who cannot join
- Women who do not speak and read English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: A Randomized Controlled Trial: Contraceptive Counseling After an Abortion
Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.
Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
Read more
Secondary Aims
- To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
- To describe the concerns that lead to discontinuation or method change. *To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.
- Conditions
- Contraception
- Being tested
- Treatment group: receives counseling phone call intervention
- Keywords
- contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment group: receives counseling phone call interventionBehavioural
Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will not receive a counseling phone call one month after enrollment. |
| Intervention | Experimental | Intervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. Receives: Behavioral: Treatment group: receives counseling phone call intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion
To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
Measured: 6 weeks after abortion procedure
Secondary outcomes (1)
Reasons for Discontinuation of Contraception
To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
To describe the concerns that lead to discontinuation or method change.
To assess feasibility of conducting a follow-up telephone call in this population
Measured: 6 weeks after abortion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study start21 Mar 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Jody Steinauer, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199952
- Sponsor's protocol ID
- RCT 10-01978
- Acronym
- PPR
- Status last verified
- Aug 2019
- First submitted
- 9 Sep 2010
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Contraceptive Counseling After an Abortion
- ClinicalTrials.gov ID
- NCT01199952
- Acronym / sponsor ID
- PPR / RCT 10-01978
- Conditions
- Contraception
- Keywords
- contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 21 Mar 2011 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.
Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
Secondary Aims
- To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
- To describe the concerns that lead to discontinuation or method change. *To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will not receive a counseling phone call one month after enrollment. |
| Intervention | Experimental | Behavioral: Treatment group: receives counseling phone call interventionIntervention arm receives a counseling phone call 3 to 4 weeks after enrollment. The call is from a health educator intended to assist with contraception. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women over the age of 15 who choose pill, patch or ring to begin after their abortion
- Women able and willing to be contacted by phone for up to 2 months after enrollment
Key exclusion criteria (1 listed)
- Women who do not speak and read English or Spanish
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 |
|---|---|---|
| Treatment group: receives counseling phone call interventionSubjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment. | Behavioural | Intervention |
Primary outcome
Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion
Time frame: 6 weeks after abortion procedure
To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.
1 secondary outcome
Reasons for Discontinuation of Contraception
Time frame: 6 weeks after abortion procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jody Steinauer, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group: receives counseling phone call intervention in people with Contraception, run by University of California, San Francisco 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 2 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 19 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion (time frame: 6 weeks after abortion 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 19 Sep 2019.