Early AbortionPhase 4NCT03829696
Advance Provision of Medication Abortion
A Phase 4 study testing Mifeprex® (Mifepristone 200 mg), Misoprostol 800 mcg and ella® (ulipristal acetate emergency contraception 30 mg) in people with Early Abortion, run by University of California, San Francisco.
Trial summary
This mixed-methods study follows a prospective cohort of participants receiving Mifeprex® (mifepristone) by a clinician in advance of a potential unintended pregnancy. Women participating in this study will be assessed by a clinician and provided Mifeprex® and misoprostol in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Abortion
- What is being tested?
- Mifeprex® (Mifepristone 200 mg), Misoprostol 800 mcg and ella® (ulipristal acetate emergency contraception 30 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jan 2021
- Phase
- Phase 4
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 40 years old
- Speak and read English or Spanish
- Have female reproductive anatomy
- Report a history of regular menses (>24 and <38 days ) in the past 3 years (other than during pregnancy)
- Not currently pregnant and not desiring to be pregnant in the next year
- Report having had a medication abortion with mifepristone and misoprostol at some point in the past
Show all 18Show fewer
- Hemoglobin ≥10 g/dL
- Do not report a history of ectopic pregnancy
- Do not report a history of a hemorrhagic disorder or currently taking anticoagulants (or plan to start taking anticoagulants during study period)
- Do not report a history of chronic adrenal failure
- Do not report a history of inherited porphyria
- Do not report an allergy to mifepristone or misoprostol
- Are not currently taking long-term corticosteroid therapy (>1 week)
- Considered at-risk for unintended pregnancy, defined as: those who report being sexually active (vaginal sex with a male); have not been told by a clinician that they cannot become pregnant; have not been sterilized and whose current sexual partner(s) has not been sterilized; who are not using a long-acting reversible contraceptive (LARC) or hormonal contraceptive; who use withdrawal, rhythm method, barrier method(s), spermicide, emergency contraception, and/or no method of contraception
- Say they would seek abortion if they became pregnant in the next year, and who do not express a preference for surgical abortion
- Willing and able to provide informed consent
- Have access to a working cellphone with them at the time of enrollment and are willing to receive calls and text messages from study staff
- Are planning to live within 25 miles of the study site for the 6 month study period
Who cannot join
- Younger than 18 years or older than 40 years
- Cannot speak and read English or Spanish
- Do not have female reproductive anatomy
- Report a history of irregular menses in the past 3 years
- Hemoglobin <10 g/dL
- Report a history of having an ectopic pregnancy
Show all 17Show fewer
- Report a history of a hemorrhagic disorder or currently taking anticoagulants (or plan to start taking anticoagulants during study period)
- Report a history of chronic adrenal failure
- Report a history of inherited porphyria
- Report an allergy to mifepristone or misoprostol
- Currently taking long-term corticosteroid therapy (>1 week)
- Are not considered at-risk for unintended pregnancy, defined as: those who do not report being sexually active (vaginal sex with a male), have been told by a clinician they cannot become pregnant, have been sterilized or whose current sexual partner(s) has been sterilized, have an IUD or contraceptive implant in place, or currently taking hormonal contraception (oral contraceptive pills, patch or vaginal ring)
- Currently pregnant or desiring to become pregnant in the next year
- Have not had a medication abortion in the past
- Say if they became pregnant in the next year, they would not seek abortion or are unsure whether they would seek abortion; or who indicate a preference for surgical abortion Unwilling or unable to provide informed consent
- Do not have access to a working cellphone with them at the time of enrollment and are unwilling to receive calls or text messages from study staff
- Are not planning to live within 25 miles of the study site for the 6 month study period
About this study
Official title: Alternative Provision of Medication Abortion Via Advance Provision
This mixed-methods study follows a prospective cohort of participants receiving Mifeprex® (mifepristone) by a clinician in advance of a potential unintended pregnancy. Women participating in this study will be assessed by a clinician and provided Mifeprex® and misoprostol in a clinical setting. To assess acceptability of this service delivery model among participants, and feasibility of implementing a larger randomized controlled trial, the study will survey participants, evaluate any clinical outcomes recorded during clinical visits, and interview participants about their experiences participating in the study.
Read the detailed description
The overarching goal of the project is to improve access to early abortion by reducing barriers that patients face obtaining services. Currently, patients are prescribed and receive Mifeprex® and misoprostol directly from a clinician, who evaluates patients for medical eligibility and contraindications. The Mifeprex® may be taken in the facility or at home, and the misoprostol is taken 24-48 hours later at home. The FDA recommends a follow-up visit, which can be over the phone.
The purpose of this study is to pilot test the model of advance provision of medication abortion (MAB). In this model, patients at risk of unintended pregnancy and with a desire to avoid pregnancy will be assessed by a clinician and provided counseling on pregnancy recognition and testing, as well as how to administer MAB at home. For this pilot study, only patients who have previously had a MAB will be included, since this population has reported the highest interest in the model, and they are also already familiar with how to use the medications. The clinician will provide Mifeprex® and misoprostol to the patient at the time of counseling in case the patient becomes pregnant and wants to terminate the pregnancy using the medications up to 10 weeks gestation. Patients will contact a study clinician for an over-the-phone assessment of eligibility for MAB, including assessment of gestational age, before self-administration of Mifeprex® and misoprostol, and then attend a follow-up visit with the clinician.
Patients will sign the Danco Patient Agreement Form prior to receiving the medication. Clinicians dispensing the medications will have signed the Prescriber Agreement Form, and the medications will be dispensed in a clinic or hospital. Study investigators will monitor participant activity through surveys throughout the study. Participants will be given clear instructions on study participation and returning unused medications in an appropriate time frame. Clinicians will also re-evaluate participants by telephone before they take the medications and evaluate them in person at a subsequent follow-up visit.
- Conditions
- Early Abortion
- Being tested
- Mifeprex® (Mifepristone 200 mg), Misoprostol 800 mcg, ella® (ulipristal acetate emergency contraception 30 mg), AccuHome® Pregnancy OTC Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifeprex® (Mifepristone 200 mg)Drug
Participants will receive Mifeprex® (mifepristone 800 mcg) from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period and would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit.
Misoprostol 800 mcgDrug
Participants will receive misoprostol from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit.
ella® (ulipristal acetate emergency contraception 30 mg)Drug
Participants will receive one dose of ella (emergency contraception) from a clinician at the same time of receiving mifepristone and misoprostol, in case the participant should have unprotected intercourse or failed contraception and want to prevent unintended pregnancy.
AccuHome® Pregnancy OTC TestDiagnostic test
Participants will receive 6 AccuHome® pregnancy tests, which are midstream urine pregnancy tests and provide results within 3 minutes. Participants may request additional tests to be mailed to them by the study at any time.
| Study group | Role | What they receive |
|---|---|---|
| Non-pregnant women | Experimental | Participants will be provided Mifeprex® (oral mifepristone 200 mg) and misoprostol 800 mcg to be administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone) if unintended pregnancy occurs during the study period and the participant would like to end of the pregnancy. Participants who test positive for pregnancy will consult with a study clinician over the phone prior to administering mifepristone and misoprostol, and will then attend an in-person follow-up visit.
All participants will be provided with a single dose of ella® (ulipristal acetate emergency contraception 30 mg) by a clinician at the beginning of the study, as well as 6 AccuHome® midstream urine pregnancy tests. Receives: Drug: Mifeprex® (Mifepristone 200 mg); Drug: Misoprostol 800 mcg; Drug: ella® (ulipristal acetate emergency contraception 30 mg); Diagnostic Test: AccuHome® Pregnancy OTC Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants satisfied with the advance provision model
Proportion of participants who report being "somewhat satisfied" or "very satisfied" when asked "How satisfied are you with the advance provision model?"
Measured: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.
Proportion of participants who are confident that they could use the abortion pills correctly if they got pregnant and decided to have an abortion using the advance provision model
Proportion of participants who report "somewhat confident" or "completely confident" when asked "If you got pregnant and wanted an abortion in the next few months, how confident do you feel that you could use the abortion pills correctly?"
Measured: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.
Proportion of participants who would recommend the advance provision model to a friend
Proportion of participants who report "probably yes" or "definitely yes" when asked "Would you recommend getting the abortion pills in advance instead of going to a clinic to a friend?"
Measured: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.
Secondary outcomes (5)
Response rate to check-in and end-of-study surveys
The number of participants who respond to surveys will be monitored throughout the study period.
Measured: End of the study, month 12
Number of participants who take Mifeprex®
The number of participants who report taking Mifeprex® will be captured by clinical recording of study clinicians during over-the-phone assessments and follow-up visits, as well as data collected during check-in and end of study surveys.
Measured: End of study, month 12
Among participants who take Mifeprex®: Number of participants who take Mifeprex® and misoprostol correctly
Correct use of medications will be assessed by the clinician at the time of follow-up care by a checklist of clinical criteria.
Measured: End of study, month 12
Among participants who take Mifeprex®: Gestational age at time of abortion
Gestational age will be calculated by last menstrual period during the over-the-phone clinical evaluation with a study clinician. Ultrasound data will be analyzed if obtained.
Measured: End of study, month 12
Among participants who take Mifeprex®: Number of participants with an adverse event
Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) after taking Mifeprex® and/or misoprostol.
Measured: Up to 6 weeks after reported use of Mifeprex®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: The study is not proceeding at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early AbortionStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Grossman, University of California, San Francisco
- Investigators
- Daniel Grossman, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829696
- Sponsor's protocol ID
- A128753_02
- Status last verified
- May 2019
- First submitted
- 9 Jan 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
FDA (2016).
Biggs MA, Ralph L, Raifman S, Foster DG, Grossman D. Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women. Contraception. 2019 Feb;99(2):118-124. doi: 10.1016/j.contraception.2018.10.007. Epub 2018 Nov 15.
PubMed 30448203
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Provision of Medication Abortion Via Advance Provision
- ClinicalTrials.gov ID
- NCT03829696
- Acronym / sponsor ID
- A128753_02
- Conditions
- Early Abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is not proceeding at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 4 Feb 2019 (actual)
- 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 mixed-methods study follows a prospective cohort of participants receiving Mifeprex® (mifepristone) by a clinician in advance of a potential unintended pregnancy. Women participating in this study will be assessed by a clinician and provided Mifeprex® and misoprostol in a clinical setting. To assess acceptability of this service delivery model among participants, and feasibility of implementing a larger randomized controlled trial, the study will survey participants, evaluate any clinical outcomes recorded during clinical visits, and interview participants about their experiences participating in the study.
Detailed description
The overarching goal of the project is to improve access to early abortion by reducing barriers that patients face obtaining services. Currently, patients are prescribed and receive Mifeprex® and misoprostol directly from a clinician, who evaluates patients for medical eligibility and contraindications. The Mifeprex® may be taken in the facility or at home, and the misoprostol is taken 24-48 hours later at home. The FDA recommends a follow-up visit, which can be over the phone.
The purpose of this study is to pilot test the model of advance provision of medication abortion (MAB). In this model, patients at risk of unintended pregnancy and with a desire to avoid pregnancy will be assessed by a clinician and provided counseling on pregnancy recognition and testing, as well as how to administer MAB at home. For this pilot study, only patients who have previously had a MAB will be included, since this population has reported the highest interest in the model, and they are also already familiar with how to use the medications. The clinician will provide Mifeprex® and misoprostol to the patient at the time of counseling in case the patient becomes pregnant and wants to terminate the pregnancy using the medications up to 10 weeks gestation. Patients will contact a study clinician for an over-the-phone assessment of eligibility for MAB, including assessment of gestational age, before self-administration of Mifeprex® and misoprostol, and then attend a follow-up visit with the clinician.
Patients will sign the Danco Patient Agreement Form prior to receiving the medication. Clinicians dispensing the medications will have signed the Prescriber Agreement Form, and the medications will be dispensed in a clinic or hospital. Study investigators will monitor participant activity through surveys throughout the study. Participants will be given clear instructions on study participation and returning unused medications in an appropriate time frame. Clinicians will also re-evaluate participants by telephone before they take the medications and evaluate them in person at a subsequent follow-up visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant women | Experimental | Drug: Mifeprex® (Mifepristone 200 mg), Drug: Misoprostol 800 mcg, Drug: ella® (ulipristal acetate emergency contraception 30 mg), Diagnostic Test: AccuHome® Pregnancy OTC TestParticipants will be provided Mifeprex® (oral mifepristone 200 mg) and misoprostol 800 mcg to be administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone) if unintended pregnancy occurs during the study period and the participant would like to end of the pregnancy. Participants who test positive for pregnancy will consult with a study clinician over the phone prior to administering mifepristone and misoprostol, and will then attend an in-person follow-up visit. All participants will be provided with a single dose of ella® (ulipristal acetate emergency contraception 30 mg) by a clinician at the beginning of the study, as well as 6 AccuHome® midstream urine pregnancy tests. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Between 18 and 40 years old
- Speak and read English or Spanish
- Have female reproductive anatomy
- Report a history of regular menses (>24 and <38 days ) in the past 3 years (other than during pregnancy)
- Not currently pregnant and not desiring to be pregnant in the next year
Key exclusion criteria (17 listed)
- Younger than 18 years or older than 40 years
- Cannot speak and read English or Spanish
- Do not have female reproductive anatomy
- Report a history of irregular menses in the past 3 years
- Hemoglobin <10 g/dL
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 |
|---|---|---|
| Mifeprex® (Mifepristone 200 mg)Participants will receive Mifeprex® (mifepristone 800 mcg) from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period and would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit. | Drug | Non-pregnant women |
| Misoprostol 800 mcgParticipants will receive misoprostol from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit. | Drug | Non-pregnant women |
| ella® (ulipristal acetate emergency contraception 30 mg)Participants will receive one dose of ella (emergency contraception) from a clinician at the same time of receiving mifepristone and misoprostol, in case the participant should have unprotected intercourse or failed contraception and want to prevent unintended pregnancy. | Drug | Non-pregnant women |
| AccuHome® Pregnancy OTC TestParticipants will receive 6 AccuHome® pregnancy tests, which are midstream urine pregnancy tests and provide results within 3 minutes. Participants may request additional tests to be mailed to them by the study at any time. | Diagnostic test | Non-pregnant women |
Primary outcome
Proportion of participants satisfied with the advance provision model
Time frame: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.
Proportion of participants who report being "somewhat satisfied" or "very satisfied" when asked "How satisfied are you with the advance provision model?"
Proportion of participants who are confident that they could use the abortion pills correctly if they got pregnant and decided to have an abortion using the advance provision model
Time frame: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.
Proportion of participants who report "somewhat confident" or "completely confident" when asked "If you got pregnant and wanted an abortion in the next few months, how confident do you feel that you could use the abortion pills correctly?"
Proportion of participants who would recommend the advance provision model to a friend
Time frame: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.
Proportion of participants who report "probably yes" or "definitely yes" when asked "Would you recommend getting the abortion pills in advance instead of going to a clinic to a friend?"
5 secondary outcomes
Response rate to check-in and end-of-study surveys
Time frame: End of the study, month 12
Number of participants who take Mifeprex®
Time frame: End of study, month 12
Among participants who take Mifeprex®: Number of participants who take Mifeprex® and misoprostol correctly
Time frame: End of study, month 12
Among participants who take Mifeprex®: Gestational age at time of abortion
Time frame: End of study, month 12
Among participants who take Mifeprex®: Number of participants with an adverse event
Time frame: Up to 6 weeks after reported use of Mifeprex®
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- BackgroundFDA (2016).
- Background: PubMed 30448203Biggs MA, Ralph L, Raifman S, Foster DG, Grossman D. Support for and interest in alternative models of medication abortion provision among a national probability sample of U.S. women. Contraception. 2019 Feb;99(2):118-124. doi: 10.1016/j.contraception.2018.10.007. Epub 2018 Nov 15.
- Individual participant dataSharing planned: No
Related trials for Early Abortion
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingObservational study
Research on Equity in Abortion Care by TeleHealth
Abortion in First Trimester, Abortion Early
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
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.
Daniel Grossman, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifeprex® (Mifepristone 200 mg), Misoprostol 800 mcg and ella® (ulipristal acetate emergency contraception 30 mg) in people with Early Abortion, run by University of California, San Francisco.
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 18 inclusion and 17 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: withdrawn, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants satisfied with the advance provision model (time frame: Participants who do not take Mifeprex® will be surveyed 6 months following study enrollment. Participants who take Mifeprex® at any point during the 6 month study period will be surveyed one week after taking Mifeprex®.). The study lists 3 primary outcomes in all. 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 NCT03829696, which also lists 2 linked publications.
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 30 May 2019.