Medical; Abortion, FetusPhase 3NCT03269279
Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy in Burkina Faso
A Phase 3 study testing Mifepristone and Misoprostol in people with Medical; Abortion, Fetus, run by Gynuity Health Projects at 4 sites in Burkina Faso.
Trial summary
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Medical; Abortion, Fetus
- What is being tested?
- Mifepristone and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesBurkina Faso
- Study dates
- 20 May 2017to 31 Dec 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to participate in the study
- Be willing to follow study procedures
- Respect legal indications for obtaining an abortion
Who cannot join
- Known allergy to mifepristone or misoprostol/prostaglandin
- Any contraindications to vaginal delivery, including placenta previa
- Previous transmural uterine incsion
Trial locations and contacts
4 sites in 1 country.
Burkina Faso4 sites, 4 recruiting
- Recruiting
CHUSS
Bobo-Dioulasso
Evelyne Komboigo, MD
- Recruiting
CMA Boromo
Boromo
Evelyne Komboigo, MD
- Recruiting
CHUYO
Ouagadougou
Evelyne Komboigo, MD
- Recruiting
CHR Ouahigouya
Ouahigouya
Evelyne Komboigo, MD
About this study
Official title: Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.
- Conditions
- Medical; Abortion, Fetus
- Being tested
- Mifepristone, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called Medabon
Medication used in conjunction with misoprostol for abortion
MisoprostolDrug
Also called Misoclear
Medication used in conjunction with mifepristone for abortion
| Study group | Role | What they receive |
|---|---|---|
| Medical abortion arm | Experimental | 200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester Receives: Drug: Mifepristone; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion
Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start20 May 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical; Abortion, FetusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blandine Thieba, MD, Study director, SOGOBEvelyne Komboigo, MD, Study chair, SOGOB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269279
- Sponsor's protocol ID
- 1036
- Status last verified
- May 2019
- First submitted
- 14 Jul 2017
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol for 2nd Trimester Termination of Pregnancy (13-22 Weeks LMP) in Burkina Faso
- ClinicalTrials.gov ID
- NCT03269279
- Acronym / sponsor ID
- 1036
- Conditions
- Medical; Abortion, Fetus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 31 Aug 2017 (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 goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Burkina Faso.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical abortion arm | Experimental | Drug: Mifepristone, Drug: Misoprostol200mg of Mifepristone and repeat doses of 400mcg of misoprostol every 3 hours administered for medical abortion in 2nd trimester |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Having an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to participate in the study
- Be willing to follow study procedures
Key exclusion criteria (3 listed)
- Known allergy to mifepristone or misoprostol/prostaglandin
- Any contraindications to vaginal delivery, including placenta previa
- Previous transmural uterine incsion
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 |
|---|---|---|
| MifepristoneAlso: MedabonMedication used in conjunction with misoprostol for abortion | Drug | Medical abortion arm |
| MisoprostolAlso: MisoclearMedication used in conjunction with mifepristone for abortion | Drug | Medical abortion arm |
Primary outcome
Rate of successful abortion
Time frame: 24 hours
Rate of successful abortion, complete evacuation of foetus and placenta with study drugs, within 24 hours of taking misoprostol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No
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.
Blandine Thieba, MD study director
SOGOB
Evelyne Komboigo, MD study chair
SOGOB
4 sites 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 and Misoprostol in people with Medical; Abortion, Fetus, run by Gynuity Health Projects at 4 sites in Burkina Faso.
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 3 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 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Burkina Faso. 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 Meighan Tarnagada, MPH (212.448.1230, mtarnagada@gynuity.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful abortion (time frame: 24 hours). 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 30 May 2019.