AbortionPhase 3NCT05839899
Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location
A Phase 3 study testing Mifepristone plus one dose Misoprostol and Mifepristone plus two doses Misoprostol in people with Abortion, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion
- What is being tested?
- Mifepristone plus one dose Misoprostol and Mifepristone plus two doses Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2023to 1 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
Principal Investigator, MD, 617-616-1600, research@pplm.org
About this study
Official title: 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.
- Conditions
- Abortion
- Being tested
- Mifepristone plus one dose Misoprostol, Mifepristone plus two doses Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone plus one dose MisoprostolDrug
Mifepristone 200mg PO, then 800 mcg of misoprostol 24-30 hours later
Mifepristone plus two doses MisoprostolDrug
Mifepristone 200mg PO, then 800 mcg misoprostol 24-30 hours later, then another 800 mcg misoprostol 4 hours after that
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone plus Single dose misoprostol | Active comparator | Participant will take mifepristone, then one dose of misoprostol at home to pass the pregnancy (current routine abortion care). Receives: Drug: Mifepristone plus one dose Misoprostol |
| Mifepristone plus two doses misoprostol | Experimental | Participant will take mifepristone, then at home will take two doses of misoprostol 4 hours apart to pass the pregnancy. Receives: Drug: Mifepristone plus two doses Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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..
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start30 Aug 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839899
- Sponsor's protocol ID
- 2023P000467
- Status last verified
- Aug 2023
- First submitted
- 4 Apr 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol for Undesired Pregnancy of Unknown Location: A Randomized Pilot Study of Misoprostol Dosing
- ClinicalTrials.gov ID
- NCT05839899
- Acronym / sponsor ID
- 2023P000467
- Conditions
- Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone plus Single dose misoprostol | Active comparator | Drug: Mifepristone plus one dose MisoprostolParticipant will take mifepristone, then one dose of misoprostol at home to pass the pregnancy (current routine abortion care). |
| Mifepristone plus two doses misoprostol | Experimental | Drug: Mifepristone plus two doses MisoprostolParticipant will take mifepristone, then at home will take two doses of misoprostol 4 hours apart to pass the pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone plus one dose MisoprostolMifepristone 200mg PO, then 800 mcg of misoprostol 24-30 hours later | Drug | Mifepristone plus Single dose misoprostol |
| Mifepristone plus two doses MisoprostolMifepristone 200mg PO, then 800 mcg misoprostol 24-30 hours later, then another 800 mcg misoprostol 4 hours after that | Drug | Mifepristone plus two doses misoprostol |
Primary outcome
Recruitment rates, to determine feasibility of recruitment
Time frame: 1 year
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.
Acceptability of second dose of misoprostol
Time frame: 1 month per subject, 1 year for all subjects
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.
Refusal rates, to determine feasibility of recruitment
Time frame: 1 year
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..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone plus one dose Misoprostol and Mifepristone plus two doses Misoprostol in people with Abortion, run by Planned Parenthood League of Massachusetts at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Director Research Ops (6176161600, research@pplm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates, to determine feasibility of recruitment (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.