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Antiprogestin

Mifepristone + Misoprostol for Abortion

Phase 3

Recruiting

Research Sponsored by Planned Parenthood League of Massachusetts

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial studies if two doses of at-home misoprostol is more successful than one dose for medication abortions with a pregnancy of unknown location.

Who is the study for?

This trial is for English-speaking individuals with a positive pregnancy test, no visible gestational sac on ultrasound, and no signs of ectopic pregnancy. They must want medication abortion and meet Planned Parenthood League of Massachusetts (PPLM) guidelines. Excluded are those under 18, unable to consent or follow the study plan, with certain medical conditions or allergies to the drugs used.Check my eligibility

What is being tested?

The study tests if taking two doses of Misoprostol at home after Mifepristone increases the rate of completed abortions in cases where early pregnancy isn't visible on an ultrasound. Participants will be randomly assigned to receive either one or two doses of Misoprostol following Mifepristone.See study design

What are the potential side effects?

Possible side effects include cramping, bleeding more than usual menstrual periods, nausea, vomiting, diarrhea, headache and dizziness. There's also a risk that the medications might not end an ectopic pregnancy if present.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of second dose of misoprostol

Recruitment rates, to determine feasibility of recruitment

Refusal rates, to determine feasibility of recruitment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mifepristone plus two doses misoprostolExperimental Treatment1 Intervention

Participant will take mifepristone, then at home will take two doses of misoprostol 4 hours apart to pass the pregnancy.

Group II: Mifepristone plus Single dose misoprostolActive Control1 Intervention

Participant will take mifepristone, then one dose of misoprostol at home to pass the pregnancy (current routine abortion care).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Planned Parenthood League of MassachusettsLead Sponsor

18 Previous Clinical Trials

14,997 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are there in the current trial?

"Affirmative. The information readily available on clinicaltrials.gov states that the study is actively searching for participants since its posting date of August 30th, 2023 and most recent update on the same day. Fifty people must be enlisted from a single facility in order to reach completion."

Answered by AI

Is the combination of Mifepristone and two doses of misoprostol recognized by the FDA?

"The safety of Mifepristone in combination with two doses of misoprostol is rated a 3, suggestive of prior clinical evidence demonstrating efficacy and multiple rounds that validate its security."

Answered by AI

Is enrollment for this trial still open?

"Clinicaltrials.gov indicates that this medical research is currently enrolling participants, with its posting date occurring on August 30th 2023 and was last updated the same day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location

2023. "Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05839899.