Legally Induced Abortion Without Mention of ComplicationPhase 4NCT02708446
A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion
A Phase 4 study testing Mifepristone, Buccal misoprostol and Sublingual misoprostol in people with Legally Induced Abortion Without Mention of Complication, run by Gynuity Health Projects at 4 sites in 4 countries.
Trial summary
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Legally Induced Abortion Without Mention of Complication
- What is being tested?
- Mifepristone, Buccal misoprostol and Sublingual misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2014to Dec 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Meet criteria to obtain abortion
- Present with closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- Have no contraindications to study procedures, according to provider
- Be able to consent to procedure, either by reading consent document or by having consent document read to her
- Be willing to follow study procedures
Who cannot join
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Armenia1 site, 1 recruiting
- Recruiting
b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)
Yerevan
Ruzanna Abrahamyan, MD, r_abrahamyan@mail.ru
Ruzanna Abrahamyan, MD
Nepal1 site, 1 recruiting
- Recruiting
Kathmandu Medical College
Kathmandu
Chanda Karki, MD, chandakarki26@gmail.com
Chanda Karki, MD
Tunisia1 site, 1 recruiting
- Recruiting
La Rabta Maternity Hospital
Tunis
Selma Hajri, MD, selma.hajri@gmail.com
Ezzedine Sfar, MD
Uzbekistan1 site, 1 recruiting
- Recruiting
Clinic No. 2, Tashkent Medical Academy
Tashkent
Dilfuza Kurbanbekova, MD, wwcuzb@gmail.com
About this study
Official title: A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
Read the detailed description
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
- Being tested
- Mifepristone, Buccal misoprostol, Sublingual misoprostol
- Keywords
- Second Trimester, Abortion, Misoprostol, Sublingual, Buccal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called miropristone, Mifeprex, Mifegyne
200mg oral mifepristone to both study arms
Buccal misoprostolDrug
Also called cytotec
doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
Sublingual misoprostolDrug
Also called cytotec
doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone
| Study group | Role | What they receive |
|---|---|---|
| Sublingual misoprostol | Active comparator | 200mg mifepristone + 400mcg sublingual misoprostol q3h Receives: Drug: Mifepristone; Drug: Sublingual misoprostol |
| Buccal misoprostol | Active comparator | 200mg mifepristone + 400mcg buccal misoprostol q3h Receives: Drug: Mifepristone; Drug: Buccal misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion by 24 hours
Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
Measured: 24 hours following the start of misoprostol
Rate of successful abortion by 48 hours
Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
Measured: 48hours following the start of misoprostol
Secondary outcomes (6)
Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).
Measured: 48 hours
Percentage of patients requiring provision of additional interventions.
Measured: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Total number of doses of misoprostol.
Measured: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment
Measured: 1 month
Pain scale (1-7) as reported by women on questionnaire
Measured: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire
Measured: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Legally Induced Abortion Without Mention of ComplicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- La Rabta Maternity Hospital, Republican Institute of RH, Perinatology, and Ob/Gyn, Kathmandu Medical College and Teaching Hospital, Clinic No. 2 of Tashkent Medical Academy
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708446
- Sponsor's protocol ID
- 1013
- Status last verified
- Jul 2016
- First submitted
- 10 Feb 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)
- ClinicalTrials.gov ID
- NCT02708446
- Acronym / sponsor ID
- 1013
- Keywords
- Second Trimester, Abortion, Misoprostol, Sublingual, Buccal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- La Rabta Maternity Hospital, Republican Institute of RH, Perinatology, and Ob/Gyn, Kathmandu Medical College and Teaching Hospital, Clinic No. 2 of Tashkent Medical Academy
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- 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 primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.
Detailed description
Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual misoprostol | Active comparator | Drug: Mifepristone, Drug: Sublingual misoprostol200mg mifepristone + 400mcg sublingual misoprostol q3h |
| Buccal misoprostol | Active comparator | Drug: Mifepristone, Drug: Buccal misoprostol200mg mifepristone + 400mcg buccal misoprostol q3h |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Meet criteria to obtain abortion
- Present with closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- Have no contraindications to study procedures, according to provider
- Be able to consent to procedure, either by reading consent document or by having consent document read to her
Key exclusion criteria (4 listed)
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
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: miropristone, Mifeprex, Mifegyne200mg oral mifepristone to both study arms | Drug | Buccal misoprostol, Sublingual misoprostol |
| Buccal misoprostolAlso: cytotecdoses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone | Drug | Buccal misoprostol |
| Sublingual misoprostolAlso: cytotecdoses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone | Drug | Sublingual misoprostol |
Primary outcome
Rate of successful abortion by 24 hours
Time frame: 24 hours following the start of misoprostol
Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
Rate of successful abortion by 48 hours
Time frame: 48hours following the start of misoprostol
Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
6 secondary outcomes
Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).
Time frame: 48 hours
Percentage of patients requiring provision of additional interventions.
Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Total number of doses of misoprostol.
Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment
Time frame: 1 month
Pain scale (1-7) as reported by women on questionnaire
Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire
Time frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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.
b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)
Yerevan, Armenia
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone, Buccal misoprostol and Sublingual misoprostol in people with Legally Induced Abortion Without Mention of Complication, run by Gynuity Health Projects at 4 sites in 4 countries.
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 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: status not confirmed, as of the sponsor's last update on 14 Jul 2016. 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 Armenia, Nepal, Tunisia, Uzbekistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful abortion by 24 hours (time frame: 24 hours following the start of misoprostol). The study lists 2 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 14 Jul 2016.