MPP: Missed Period Pill Study

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04940013
Collaborator
(none)
100
1
1
10.2
9.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessing the Acceptability of Using Misoprostol Alone for Menstrual Regulation
Actual Study Start Date :
Oct 25, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Study participants

Study participants will be persons who have late period of up to 14 days

Drug: Misoprostol
Study participants are given misoprostol alone for menstrual regulation.

Outcome Measures

Primary Outcome Measures

  1. Interest in missed period pills [Documented at Enrollment Survey]

    The proportion of the clinic-going population that may be interested in a missed period pill and accept not having their pregnancy confirmed beforehand, therefore not knowing whether they terminated a pregnancy.

  2. Satisfaction with missed period pills [Documented at Follow-up Survey, 4 weeks after drug administration]

    The proportion of participants reporting being "satisfied" or "very satisfied" with the missed period pills on a five-point Likert scale at 4 weeks.

Secondary Outcome Measures

  1. Efficacy of missed period pills [Documented at the second study visit, through study completion at around 4 weeks after drug adminstration]

    The proportion of participants that successfully brought down their period, resulting in a negative pregnancy test and the return of their period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco (Berkeley) Berkeley California United States 94702

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Ushma Upadhyay, PhD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04940013
Other Study ID Numbers:
  • 20-30048
First Posted:
Jun 25, 2021
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2021