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The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.
Period pills (a combination of mifepristone and misoprostol) for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. In the United States (U.S.), a handful of providers currently offer period pills alongside other contraceptive and abortion services in their practice (https://www.periodpills.org/providers). This proposed study would aim to assess the acceptability of this growing service as a fertility regulation method to be utilized before a person confirms they are pregnant.
Dr. Ushma Upadhyay (Professor) and Dr. Tania Serna (Associate Clinical Professor) at UCSF's Department of Obstetrics, Gynecology & Reproductive Science are proposing the Period Pills Study to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is late, or missed. This study will aim to recruit 100 participants who have a late period to address research questions that focus on the feasibility and acceptability of using period pills for menstrual regulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Experimental | Study participants will be persons who have late period of up to 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone + Misoprostol | Drug | Study participants are given mifepristone and misoprostol for menstrual regulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interest in period pills | The proportion of the clinic-going population that may be interested in a period pill to bring on a late period and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy. | Documented at Enrollment Survey |
| Satisfaction with period pills | The proportion of participants reporting being "satisfied" or "very satisfied" with the period pills on a five-point Likert scale at follow-up (4 weeks). | Documented at Follow-up Survey, 4 weeks after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of period pills | The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period. | Documented at the follow-up visit, through study completion at around 4 weeks after drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ushma D Upadhyay, PhD, MPH | Contact | 415-353-4626 | ushma.upadhyay@ucsf.edu | |
| Jennifer Ko, MLIS | Contact | 415-353-9113 | jennifer.ko@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ushma D Upadhyay, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Advancing New Standards in Reproductive Health (ANSIRH) | Active, not recruiting | Oakland | California | 94612 | United States |
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| Label | URL |
|---|---|
| Period Pills Study Website | View source |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Roanoke Health Center | Recruiting | Roanoke | Virginia | 24017 | United States |
|
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |