Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location

Launched by PLANNED PARENTHOOD LEAGUE OF MASSACHUSETTS · Apr 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two doses of misoprostol for women who have a "pregnancy of unknown location" and are seeking a medication abortion. In simple terms, this means that during their ultrasound, doctors couldn't find the pregnancy in the uterus, which could mean it is either too early to see or possibly outside the uterus, which can be dangerous. The trial aims to find out if giving patients two doses of misoprostol, instead of one, helps them successfully complete the abortion process.

To participate in the study, women must be at least 18 years old, have a positive pregnancy test, and not show any signs of ectopic pregnancy on their ultrasound. They also need to want to start the abortion process the same day. If eligible, participants will first receive mifepristone at the clinic and then be randomly assigned to either one or two doses of misoprostol to take at home. This trial is important as it could improve the care and outcomes for women facing this situation.

Gender

FEMALE

Eligibility 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