Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location

NCT ID: NCT05839899

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone plus Single dose misoprostol

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

Group Type: ACTIVE_COMPARATOR

Mifepristone plus one dose Misoprostol

Intervention Type: DRUG

Mifepristone 200mg PO, then 800 mcg of misoprostol 24-30 hours later

Mifepristone plus two doses misoprostol

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

Group Type: EXPERIMENTAL

Mifepristone plus two doses Misoprostol

Intervention Type: DRUG

Mifepristone 200mg PO, then 800 mcg misoprostol 24-30 hours later, then another 800 mcg misoprostol 4 hours after that

Interventions

Mifepristone plus one dose Misoprostol

Mifepristone 200mg PO, then 800 mcg of misoprostol 24-30 hours later

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Planned Parenthood League of Massachusetts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Planned Parenthood League of Massachusetts

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Director Research Ops

Role: CONTACT

research@pplm.org

6176161600

Facility Contacts

Principal Investigator, MD

Role: primary

research@pplm.org

617-616-1600

Other Identifiers

2023P000467

Identifier Type: -

Identifier Source: org_study_id