Advance Provision of Medication Abortion
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|ClinicalTrials.gov Identifier: NCT03829696|
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Early Abortion||Drug: Mifeprex® (Mifepristone 200 mg) Drug: Misoprostol 800 mcg Drug: ella® (ulipristal acetate emergency contraception 30 mg) Diagnostic Test: AccuHome® Pregnancy OTC Test||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective cohort|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Alternative Provision of Medication Abortion Via Advance Provision|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Non-pregnant women
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.
Drug: 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: Misoprostol 800 mcg
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.
Drug: 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.
Diagnostic Test: AccuHome® Pregnancy OTC 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.
- 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?"
- Response rate to check-in and end-of-study surveys [ Time Frame: End of the study, month 12 ]The number of participants who respond to surveys will be monitored throughout the study period.
- Number of participants who take Mifeprex® [ Time Frame: End of study, month 12 ]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.
- Among participants who take Mifeprex®: Number of participants who take Mifeprex® and misoprostol correctly [ Time Frame: End of study, month 12 ]Correct use of medications will be assessed by the clinician at the time of follow-up care by a checklist of clinical criteria.
- Among participants who take Mifeprex®: Gestational age at time of abortion [ Time Frame: End of study, month 12 ]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.
- Among participants who take Mifeprex®: Number of participants with an adverse event [ Time Frame: Up to 6 weeks after reported use of Mifeprex® ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829696
|Contact: Katherine Ehrenreich, MScemail@example.com|
|Contact: Rana Barar, MPHfirstname.lastname@example.org|
|Principal Investigator:||Daniel Grossman, MD||University of California, San Francisco|