NCT05839899

Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location

Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location: A Randomized Pilot Study of Misoprostol Dosing

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Planned Parenthood League of Massachusetts · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Patients who seek medication abortion early in pregnancy may have an ultrasound that does not show a pregnancy in the uterus. This is known as a "pregnancy of unknown location". These patients most likely have a pregnancy in the uterus that is too early to be seen on ultrasound, but it is possible that the pregnancy is not seen inside the uterus because it is outside of the uterus, known as an ectopic pregnancy. Patients with ectopic pregnancies are at risk for serious complications, and the medications used for medication abortion may not end an ectopic pregnancy. Currently, at Planned Parenthood League of Massachusetts (PPLM), patients seeking medication abortion, including some patients with a pregnancy of unknown location, are given mifepristone to begin the medication abortion at the clinic and then one dose of misoprostol to take at home to cause the pregnancy to pass. However, research suggests that a second dose of misoprostol leads to a higher rate of completed abortion for certain patients. This research is being conducted to learn if two doses of the at-home misoprostol during the medication abortion process leads to a higher rate of completed abortion for patients with pregnancy of unknown location. In this study, all participants will receive mifepristone as they normally would. Then, participants will be randomly assigned to receive either one dose of misoprostol or two doses of misoprostol.

Conditions

• Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone plus one dose Misoprostol	Mifepristone 200mg PO, then 800 mcg of misoprostol 24-30 hours later
DRUG	Mifepristone plus two doses Misoprostol	Mifepristone 200mg PO, then 800 mcg misoprostol 24-30 hours later, then another 800 mcg misoprostol 4 hours after that

Timeline

• Start date: 2023-08-30
• Primary completion: 2024-07-01
• Completion: 2024-09-01
• First posted: 2023-05-03
• Last updated: 2023-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study