Using Mifepristone and Misoprostol for Early Pregnancy Termination
Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location: A Randomized Pilot Study of Misoprostol Dosing
This study is testing if giving a second dose of misoprostol along with mifepristone can help people with a positive pregnancy test but no visible pregnancy on an ultrasound successfully end their pregnancy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Planned Parenthood League of Massachusetts Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05839899 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of mifepristone combined with one or two doses of misoprostol for patients experiencing a pregnancy of unknown location. Patients seeking medication abortion who have a positive pregnancy test but no visible gestational sac on ultrasound will be enrolled. The study aims to determine if administering a second dose of misoprostol increases the rate of successful abortion. The trial is conducted at Planned Parenthood League of Massachusetts, focusing on ensuring safe and effective abortion care.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals with a positive pregnancy test and no evidence of ectopic pregnancy who desire same-day medication abortion.
Not a fit: Patients who are ineligible for medication abortion based on Planned Parenthood clinical guidelines or have contraindications to the medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the effectiveness of medication abortion for patients with early pregnancies that are difficult to diagnose.
How similar studies have performed: Previous studies have suggested that additional doses of misoprostol may enhance the effectiveness of medication abortion, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Positive urine or serum hCG test * No evidence of gestational sac on transvaginal ultrasound * No evidence of ectopic pregnancy on transvaginal ultrasound * Desire for same-day start medication abortion as method of pregnancy termination * Eligible for same-day-start medication abortion based on PPLM clinical guidelines at the time of enrollment * English-speaking Exclusion Criteria: * Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines at the time of enrollment o PPLM clinical guidelines for medication abortion currently exclude those with chronic adrenal failure, concurrent long-term corticosteroid use, hemorrhagic disorders or concurrent anti-coagulation, porphyria, allergies to mifepristone or misoprostol, or an IUD in place. * Ineligible for same-day-start medication abortion with PUL based on PPLM clinical guidelines and clinician assessment at the time of enrollment o PPLM clinical guidelines for initiating medication abortion with PUL currently exclude those with major ectopic risk factors (IUD in situ, prior ectopic, history of tubal surgery) or symptoms concerning for ectopic (i.e. pain, bleeding) per clinician discretion. * Age less than 18 years old * Prior participation in this study * Anticipated inability to adhere to follow up protocol or complete the survey * Unable to give informed consent or to complete all study procedures
Where this trial is running
Boston, Massachusetts
- Planned Parenthood League of Massachusetts — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Director Research Ops
- Email: research@pplm.org
- Phone: 6176161600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.