Second Trimester AbortionPhase 4NCT04063904
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
A Phase 4 study testing Mifepristone and Misoprostol in people with Second Trimester Abortion, run by Gynuity Health Projects at 1 site in Colombia.
Trial summary
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. 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
- Second Trimester Abortion
- What is being tested?
- Mifepristone and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteColombia
- Study dates
- 16 Oct 2019to 3 Apr 2021
- Phase
- Phase 4
- 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
- Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
- Meet legal criteria to obtain abortion
- Be at least 18 years old
- Have access to a phone where she can be reached for the 2-week follow up
- Be willing to follow pilot study procedures
Who cannot join
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- More than one prior cesarean delivery
- Staying more than 2 hours away from the clinic
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\&E will be performed to complete the abortion.
- Conditions
- Second Trimester Abortion
- Being tested
- Mifepristone, Misoprostol
- Keywords
- medical abortion, mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
One 200 mg pill (oral)
MisoprostolDrug
Two 400 mcg pills (sublingual)
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone and misoprostol | Experimental | Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion. Receives: Drug: Mifepristone; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful medical abortion
Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.
Measured: 0-60 hours after mifepristone
Secondary outcomes (9)
Induction-to-abortion interval
Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion
Measured: 0-12 hours after misoprostol
Initiation-to-abortion interval
Time (median min/hrs) from mifepristone administration until fetal and placental expulsion
Measured: 0-60 hours after mifepristone
Total dose of misoprostol administered
Mean number of misoprostol doses administered to achieve abortion
Measured: 0-12 hours after misoprostol
Method safety
Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications
Measured: Two weeks after mifepristone
Tasks performed by clinic staff
Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider
Measured: From enrollment through discharge from care (approx. 3 days)
Total clinic time
Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day
Measured: 0-12 hours from arrival at clinic on day of induction with misoprostol
Pain with procedure
Mean pain score (scale 0-10)
Measured: 0-12 hours after first misoprostol dose
Side effects
Report of side effects and proportion of participants who experienced each one
Measured: 0-12 hours after first misoprostol dose
Satisfaction with procedure
Proportion of participants who reported the procedure as satisfactory or very satisfactory
Measured: Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start16 Oct 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2021
Why it stopped: Difficulties with recruitment, COVID 19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Trimester 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilana G Dzuba, MHS, Principal investigator, Gynuity Health ProjectsMaria Mercedes Vivas, MD, Principal investigator, Fundacion OrientameJuliette Ortiz, Study director, Fundacion OrientameBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063904
- Sponsor's protocol ID
- 1044
- Status last verified
- Jul 2021
- First submitted
- 13 Aug 2019
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
- ClinicalTrials.gov ID
- NCT04063904
- Acronym / sponsor ID
- 1044
- Conditions
- Second Trimester Abortion
- Keywords
- medical abortion, mifepristone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with recruitment, COVID 19 pandemic
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2021 (actual)
- First posted
- 21 Aug 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.
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\&E will be performed to complete the abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mifepristone and misoprostol | Experimental | Drug: Mifepristone, Drug: MisoprostolMifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound
- Meet legal criteria to obtain abortion
- Be at least 18 years old
- Have access to a phone where she can be reached for the 2-week follow up
- Be willing to follow pilot study procedures
Key exclusion criteria (4 listed)
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- More than one prior cesarean delivery
- Staying more than 2 hours away from the clinic
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 |
|---|---|---|
| MifepristoneOne 200 mg pill (oral) | Drug | Mifepristone and misoprostol |
| MisoprostolTwo 400 mcg pills (sublingual) | Drug | Mifepristone and misoprostol |
Primary outcome
Successful medical abortion
Time frame: 0-60 hours after mifepristone
Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.
9 secondary outcomes
Induction-to-abortion interval
Time frame: 0-12 hours after misoprostol
Initiation-to-abortion interval
Time frame: 0-60 hours after mifepristone
Total dose of misoprostol administered
Time frame: 0-12 hours after misoprostol
Method safety
Time frame: Two weeks after mifepristone
Tasks performed by clinic staff
Time frame: From enrollment through discharge from care (approx. 3 days)
Total clinic time
Time frame: 0-12 hours from arrival at clinic on day of induction with misoprostol
Pain with procedure
Time frame: 0-12 hours after first misoprostol dose
Side effects
Time frame: 0-12 hours after first misoprostol dose
Satisfaction with procedure
Time frame: Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose
Results and safety
The study was stopped early (reason given: Difficulties with recruitment, COVID 19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
Ilana G Dzuba, MHS principal investigator
Gynuity Health Projects
Maria Mercedes Vivas, MD principal investigator
Fundacion Orientame
Juliette Ortiz study director
Fundacion Orientame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone and Misoprostol in people with Second Trimester Abortion, run by Gynuity Health Projects at 1 site in Colombia.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Jul 2021. 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 Colombia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties with recruitment, COVID 19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful medical abortion (time frame: 0-60 hours after mifepristone). 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 23 Jul 2021.