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

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.

Study Overview

• Status: Recruiting
• Conditions: Abortion
• Intervention / Treatment: Drug: Mifepristone plus one dose Misoprostol; Drug: Mifepristone plus two doses Misoprostol

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Director Research Ops; Phone Number: 6176161600; Email: research@pplm.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Planned Parenthood League of Massachusetts
      • Contact: Principal Investigator, MD; Phone Number: 617-616-1600; Email: research@pplm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: Mifepristone plus one dose Misoprostol; Mifepristone 200mg PO, then 800 mcg of misoprostol 24-30 hours later
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates, to determine feasibility of recruitment	Feasibility of recruitment will be assessed by the recruitment and refusal rates. The recruitment rate will be calculated by dividing the total number of participants recruited by the number of months spent for recruitment.	1 year
Acceptability of second dose of misoprostol	Acceptability of this regimen will be assessed by measuring how often patients assigned to the treatment arm actually take the second dose of misoprostol. If 13 or more patients in the double-miso group (>50%) do not take the second dose, this will be considered unacceptable.	1 month per subject, 1 year for all subjects
Refusal rates, to determine feasibility of recruitment	Feasibility recruitment will be assessed by the recruitment and refusal rates. The refusal rate will be calculated by dividing the total number of participants recruited by the number of patients approached for study participation..	1 year

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 2023P000467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes