Menstrual Health Intervention, Menstrual Regulation
Conditions
Keywords
late period, missed period, mestruation
Brief summary
The Period Pills Study is a prospective observational study among people who decide to use a combination of mifepristone and misoprostol for menstrual regulation.
Detailed description
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.
Interventions
Study participants are given mifepristone and misoprostol for menstrual regulation.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be 18 years old or older * Read and speak English * Know the date of their last menstrual period within 2 days * Have a period that is late by up to 21 days * Must have had regular periods in the last 4 months * Does not want to be pregnant * Does not want to verify pregnancy status * Understand that if they are pregnant, the pills will end their pregnancy * Does not have contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
Exclusion criteria
* Under 18 years old * Does not read and speak English * Does not know the date of their last menstrual period within 2 days * Has not had regular periods in the last 4 months * Wants to be pregnant * Wants to verify pregnancy status * Does not display understanding that if they are pregnant, the pills will end their pregnancy * Has any contraindications to mifepristone and misoprostol (Risk factors for ectopic pregnancy; history of bleeding disorder or anticoagulant therapy; history of chronic adrenal failure, long-term corticosteroid therapy; allergy to mifepristone/misoprostol/prostaglandins; history of hemorrhagic disorders or anticoagulant therapy; history of inherited porphyrias; has an IUD; currently use a contraceptive implant or injectable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interest in period pills | Documented at Enrollment Survey | 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. |
| Satisfaction with period pills | Documented at Follow-up Survey, 4 weeks after drug administration | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of period pills | Documented at the follow-up visit, through study completion at around 4 weeks after drug administration. | The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period. |
Countries
United States
Contacts
CONTACTUshma D Upadhyay, PhD, MPH
CONTACTJennifer Ko, MLIS
PRINCIPAL_INVESTIGATORUshma D Upadhyay, PhD, MPH
University of California, San Francisco
Outcome results
None listed