Recruiting
Phase 3

Mifepristone & Misoprostol

Sponsor:

Planned Parenthood League of Massachusetts

Code:

NCT05839899

Conditions

Abortion

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Mifepristone plus one dose Misoprostol

Mifepristone plus two doses Misoprostol

Study Details

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 ID

NCT05839899

Start date

Aug 30, 2023

Status verified date

Aug, 2023

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Jul 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mifepristone plus Single dose misoprostol

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

experimental: 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.

Interventions

Mifepristone plus one dose Misoprostol

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

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

Primary outcome measure

  • Recruitment rates, to determine feasibility of recruitment [ Time Frame: 1 year ]
  • Acceptability of second dose of misoprostol [ Time Frame: 1 month per subject, 1 year for all subjects ]
  • Refusal rates, to determine feasibility of recruitment [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Director Research Ops

6176161600research@pplm.org

Locations

Planned Parenthood League of Massachusetts

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator, MD

617-616-1600research@pplm.org

More Information

Sponsor

Planned Parenthood League of Massachusetts

Last update posted

Sep 5, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Planned Parenthood League of Massachusetts on 2023-09-05.