Missed Period Pill Study (MPP)

University of California San Francisco (UCSF)

Status and phase

Terminated

Phase 4

Conditions

Menstrual Irregularity

Menstrual Regulation

Treatments

Drug: Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT04940013

20-30048

Details and patient eligibility

About

The Missed Period Pill Study is a prospective observational study among people who decide to use misoprostol alone for menstrual regulation.

Full description

As the number of state laws restricting access to abortion increases across the country, more creative methods are needed to support individuals in achieving their reproductive goals. Misoprostol alone for people who suspect, but have not confirmed pregnancy, has the potential to fulfill this growing need. The goal of this research study is to test a traditional but underutilized framework of menstrual regulation for pregnancy loss, to "bring back" a period when it is missed. This study will aim to recruit 100 patients who have a missed period to address research questions that focus on the feasibility and acceptability of using misoprostol alone for menstrual regulation.

The study will require 1 study visit and 1 telehealth visit.

First study visit: A urine sample will be collected which will later undergo pregnancy testing. Participants will be given misoprostol along with instructions and information on what to expect. The participant will be required to return to the clinic 4 weeks later to provide another urine sample. The participant will not know the results of the first visit's pregnancy test at any point. The clinic staff member administering the participant's care will not know of the pregnancy test result while the participant is at the clinic.

Telehealth visit: The second visit will be by phone or video. The participant will conduct a pregnancy test and inform the research staff of the result. The participant will then be asked to answer questions on an online survey about their experience using misoprostol.

A variety of clinical and social science measures will be collected to assess the feasibility and acceptability of this traditional concept of menstrual regulation utilizing uterine evacuation with medications.

Enrollment

17 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 14 days
Have had regular periods in the last 4-6 months
Does not want to be pregnant; understand that if they are pregnant, the pills will end their pregnancy
Be willing to have an abortion if the missed period pill does not work, and informed of potential for birth defects in any ongoing pregnancy
Does not want to verify pregnancy status
Does not have risk factors for ectopic pregnancy (history of ectopic pregnancy, recent vaginal bleeding or spotting, pelvic pain on one side, prior permanent contraception, or other tubal surgery)
Does not have an IUD
Does not currently use a contraceptive implant or injectable
Does not have contraindications to misoprostol
Agree to participate in the follow up visit/call

Exclusion criteria

Participants who have contraindications to misoprostol
Unknown date of last menstrual period
Risk factors for ectopic pregnancy (history of ectopic pregnancy, recent vaginal bleeding or spotting, pelvic pain on one side, prior permanent contraception, or other tubal surgery)
Irregular menses or any other condition that in the opinion of the Principal Investigator would compromise participant safety.