Pregnancy RelatedMAPULNCT04026789
Medication Abortion for Pregnancy of Unknown Location
A study testing Same-day-start and Delay-for-diagnosis in people with Pregnancy Related, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial summary
The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location. 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
- Pregnancy Related
- What is being tested?
- Same-day-start and Delay-for-diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 31 Jul 2021
- Phase
- Interventional
- 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
- Desire for medication abortion as method of pregnancy termination
Who cannot join
- Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines
- Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
- High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
- Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
- LMP > 42 days or unknown LMP
- Age less than 18 years
- Prior participation in this study
- Anticipated inability to present for scheduled follow-up visits
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
PPLM
Boston, Massachusetts, 02215
Research Manager, 617-616-1600, research@pplm.org
About this study
The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.
- Conditions
- Pregnancy Related
- Being tested
- Same-day-start, Delay-for-diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-day-startOther
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing
Delay-for-diagnosisOther
Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion
| Study group | Role | What they receive |
|---|---|---|
| Same-day-start | Active comparator | Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing Receives: Other: Same-day-start |
| Delay-for-diagnosis | Active comparator | Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion Receives: Other: Delay-for-diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completed abortion
Time to completed abortion as defined by the number of days between initial ultrasound diagnosis of PUL to the diagnostic test that confirms complete abortion
Measured: through study completion, an average of two weeks
Secondary outcomes (4)
Number of participants with complete expulsion of pregnancy without surgical intervention
Efficacy of medical abortion, defined as number of participants with complete expulsion of pregnancy without surgical intervention
Measured: 14 days after initiation of medical abortion
Time to diagnosis of pregnancy outcome
Number of days between initial ultrasound diagnosis of pregnancy of unknown location and diagnosis of pregnancy outcome, with options including intrauterine pregnancy, ectopic pregnancy, or early pregnancy loss
Measured: Within 2 weeks of identification of pregnancy of unknown location on ultrasound
Rate of ectopic pregnancy
Rate of ectopic pregnancy among entire study population
Measured: Within 2 weeks of identification of pregnancy of unknown location on ultrasound
Percent of participants who complete follow-up and confirm complete abortion
Percent of participants who adhered to recommended follow-up plan and confirmed a complete abortion through ultrasound or hCG
Measured: Within 1 month of identification of pregnancy of unknown location on ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start22 Jul 2019
- Primary completion17 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT04026789
- Sponsor's protocol ID
- 2019P000848
- Acronym
- MAPUL
- Status last verified
- Oct 2020
- First submitted
- 16 Jul 2019
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data with any other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Abortion for Pregnancy of Unknown Location
- ClinicalTrials.gov ID
- NCT04026789
- Acronym / sponsor ID
- MAPUL / 2019P000848
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 17 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 19 Jul 2019 (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.
The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial (plus prospective cohort for those interested in participation but unwilling to be randomized)
| Arm | Type | Receives |
|---|---|---|
| Same-day-start | Active comparator | Other: Same-day-startPatients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing |
| Delay-for-diagnosis | Active comparator | Other: Delay-for-diagnosisPatients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive urine or serum hCG test
- No evidence of gestational sac on transvaginal ultrasound
- Desire for medication abortion as method of pregnancy termination
Key exclusion criteria (8 listed)
- Ineligible for medication abortion at PPLM based on current PPLM clinical guidelines
- Reasonable clinical suspicion for ectopic or molar pregnancy, such as abnormal or concerning ultrasound findings
- High risk for ectopic pregnancy, such as prior ectopic pregnancy, history of tubal surgery, concurrent intrauterine device in place during this pregnancy
- Exhibiting symptoms of possible ectopic, such as vaginal bleeding or abdominal pain
- LMP > 42 days or unknown LMP
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 |
|---|---|---|
| Same-day-startPatients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing | Other | Same-day-start |
| Delay-for-diagnosisPatients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion | Other | Delay-for-diagnosis |
Primary outcome
Time to completed abortion
Time frame: through study completion, an average of two weeks
Time to completed abortion as defined by the number of days between initial ultrasound diagnosis of PUL to the diagnostic test that confirms complete abortion
4 secondary outcomes
Number of participants with complete expulsion of pregnancy without surgical intervention
Time frame: 14 days after initiation of medical abortion
Time to diagnosis of pregnancy outcome
Time frame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound
Rate of ectopic pregnancy
Time frame: Within 2 weeks of identification of pregnancy of unknown location on ultrasound
Percent of participants who complete follow-up and confirm complete abortion
Time frame: Within 1 month of identification of pregnancy of unknown location on ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data with any 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 study testing Same-day-start and Delay-for-diagnosis in people with Pregnancy Related, 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 3 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 Oct 2020. 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.
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 Principal Investigator (6176161600, research@pplm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to completed abortion (time frame: through study completion, an average of two weeks). 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 Oct 2020.