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| Name | Class |
|---|---|
| University of Utah | OTHER |
| Planned Parenthood Association of Utah | UNKNOWN |
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The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States.
The main questions it aims to answer are:
Participants will:
The investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority
This is a randomized controlled trial comparing misoprostol-only (3-4 doses x 800μg misoprostol sublingually every 3 hours) (Arm 2) to the combined regimen (<64 days: mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days) (Arm 1). The combined regimen is the standard of care for medication abortion in the United States, and both regimens are widely used across the globe for termination of pregnancy. Participants will be randomized to each group in a 1:1 ratio based on duration of pregnancy at enrollment. The primary outcome is the proportion who have a complete abortion (no ongoing pregnancy) without procedural intervention or additional doses of medication as determined by negative HSPT between 28-42 days, ultrasound, or declining serum beta hCG by clinic protocols. Side effects, additional interventions, adverse events, acceptability, and quality of care will be assessed with daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.
The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT between 28-42 days, ultrasound, or declining serum beta hCG by clinic protocols. The investigators will report abortion completion overall by study arm. Additionally, the investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen.
Participants will be determined to have had a complete abortion without need for procedural intervention or additional doses of medication, and the investigators will also report the number and proportion of complete abortions as defined more broadly by the MARE guidelines as successful expulsion of the intrauterine pregnancy without need for procedural intervention.
Secondary study endpoints include:
• change in serum beta hCG 7-14 days following use of the misoprostol-only regimen and in the mifepristone-misoprostol regimen
In more detail, secondary outcomes to be measured include declines in serum beta hCG between baseline and 7-14 days among a subset of participants to characterize patterns following use of the misoprostol-only regimen and the combined mifepristone-misoprostol regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined regimen | Active Comparator | Participants in this arm are randomized to receive the standard of care combined mifepristone + misoprostol regimen. Specifically, for those with pregnancies <64 days, mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v); for those 64-77 days, they will take a second dose of misoprostol (800μg b/v) taken 3 hours later. |
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| Misoprostol-only | Experimental | Participants in this arm will be randomized to receive a misoprostol-only regimen. Specifically, 3-4 doses of 800μg misoprostol administered sublingually every 3 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol-only medication abortion regimen | Drug | This intervention is an updated misoprostol-only regimen that involves being counseled on and receiving medications for a medication abortion using 3-4 doses of 800μg misoprostol administered sublingually every 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Abortion completion | The primary outcome for this study is complete abortion, defined as successful expulsion of the intrauterine pregnancy without need for procedural intervention or additional doses of medication during the follow-up period as determined by negative HSPT, ultrasound, or declining serum beta hCG by clinic protocols. | 28-42 days after taking the pills |
| Non-inferiority of the misoprostol-only regimen | Study investigators will evaluate and report on the non-inferiority of abortion completion following use of the misoprostol-only regimen as compared to the combined mifepristone and misoprostol regimen within a 5% margin of inferiority. | Completion measured 28-42 days after taking the pills |
| Measure | Description | Time Frame |
|---|---|---|
| hCG decline | We will measure declines in serum beta hCG between baseline and 7-14 days among a subset of participants to characterize patterns following use of the misoprostol-only regimen and the combined mifepristone-misoprostol regimen. | Change in beta hCG between 0 and 7-14 days post medication abortion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood Association of Utah | Salt Lake City | Utah | 84102 | United States |
We will share a de-identified dataset that includes at a minimum: treatment group, adherence to treatment, and primary outcome (abortion completion).
At a minimum, we will make key components of the study protocol as well as a de-identified dataset with key data elements available to members of the scientific community within 6 months of publication of the primary and secondary study outcomes.
Interested researchers can contact the study team with a brief analysis plan and the research team will share the data with those researchers.
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| Combined regimen | Drug | This intervention will involve participants being counseled on and receiving medications for a medication abortion regimen of mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b/v) with a second dose of misoprostol (800μg b/v) taken 3 hours later only for those 64-77 days. |
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