Medical AbortionPhase 4NCT02745093
Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks
A Phase 4 study testing Mifepristone and Misoprostol in people with Medical Abortion, run by Ibis Reproductive Health at 3 sites in Mexico.
Trial summary
The purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12 weeks among a cohort of women in Mexico City. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Medical 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
- 648 participants
- Where
- 3 sitesMexico
- Study dates
- Sep 2016to 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Intrauterine pregnancy 57- 84 days, assessed using clinical assessment and transvaginal or transabdominal ultrasound by crown-rump length (machines will be calibrated and will use a standardized conversion formula to determine gestational age)
- Eligible for medical abortion according to doctor assessment
- Elected medical abortion over surgical abortion after comprehensive counselling
- Haemoglobin level ≥10 g/dl measured by Hemocue
- Willing and able to sign consent forms
Show all 11Show fewer
- Able to speak and read Spanish
- Agree to comply with the study procedures and visit schedule
- Access to own telephone and to emergency transportation
- Access to a toilet with privacy
- Reside no more than 30 minutes car journey from the Sta. Mónica Hospital in Polanco or the Marie Stopes Mexico Roma Clinic
Who cannot join
- History or evidence of disorders that represent a contraindication to the use of mifepristone or misoprostol (chronic adrenal failure, severe asthma uncontrolled by corticosteroid therapy, inherited porphyries, glaucoma, mitral stenosis, hepatic or renal disease)
- History of bleeding disorder or current anticoagulant therapy
- Previous allergic reaction to any drugs in the regimen
- Suspicion of any pathology of pregnancy (e.g. molar, ectopic, non-viable pregnancy)
- Multiple gestation
- Presence of an intrauterine device
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Marie Stopes Mexico Azcapotzalco
Del. Azcapotzalco, Mexico Distrito Federal, 02000
Marie Stopes Mexico Roma
Del. Cuauhtémoc, Mexico Distrito Federal, 06760
Marie Stopes Mexico Pedregal
Del. Tlalpan, Mexico Distrito Federal, 14010
About this study
Official title: The Effectiveness, Safety, and Acceptability of Home-administered Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks: A Prospective Cohort Study in Mexico City
The purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12 weeks among a cohort of women in Mexico City.
Read the detailed description
Medical abortion represents an important alternative to surgical methods for termination of early pregnancy. In Mexico City, abortion is legal on request up to 12 weeks of gestation; however, medical abortion is currently only offered up to 10 weeks at Marie Stopes Mexico clinics. The World Health Organization guidelines state that medical abortion drugs may be used to terminate pregnancy up to a gestational age of 24 weeks in clinical settings, with recommended regimens differing by gestational age. However, data are lacking on the safety and effectiveness of home-based medical abortion regimens for pregnancy terminations between >9 and ≤12 weeks' gestation. Investigators propose a prospective cohort study with women between 8 and ≤9 weeks and >9 and ≤12 weeks of pregnancy at Marie Stopes Mexico clinics to compare the effectiveness, safety, and acceptability of mifepristone followed by home-based misoprostol use in these two gestational age groups. The information from this study will inform policy and practice guidelines in Mexico City and potentially other locations by providing evidence on the safety, effectiveness, and acceptability of home-use of medical abortion between >9 and ≤12 weeks of gestation.
- Conditions
- Medical Abortion
- Being tested
- Mifepristone, Misoprostol
- Keywords
- Abortion induced, Patient Acceptance of Healthcare, safety, effectiveness, misoprostol, mifepristone
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.
MisoprostolDrug
The client will then be given a total of 2400 µg misoprostol tablets to take home, and will be instructed to take 800 μg misoprostol administered sublingually 24-48 hours later at home and to administer a subsequent dose of 400 μg misoprostol sublingually every 3 hours up to a total of four further doses or until expulsion of the products of conception, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| 64-84 days gestational age | Experimental | Women whose pregnancies are estimated to have a gestational age of 64-84 days will receive 200 µg mifepristone followed by misoprostol 24-48 hours later. Receives: Drug: Mifepristone; Drug: Misoprostol |
| 57-63 days gestational age | No intervention | Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range: 200 µg mifepristone administered orally in the clinic on Day 1 then 800 μg misoprostol administered sublingually 24-48 hours later at home with a subsequent dose of 400 μg misoprostol sublingually 6 hours later if she has not expelled the pregnancy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with complete abortion without surgical intervention by day 30 from mifepristone administration, regardless of misoprostol dosing, by gestational age group
Measured: 2-4 weeks
Secondary outcomes (22)
Experience of any major adverse event overall, and by type (emergency room treatment, hospitalization, transfusion, unrecognized ectopic pregnancy, allergic reaction, infection requiring intravenous treatment, and death), by gestational age group
Measured: 2-4 weeks
Proportion of participants by gestational age group with complete abortion without surgical intervention after 1, 2, 3, 4, and 5 doses of misoprostol, by gestational age group
Measured: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group
Measured: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to the presence of a persistent non-viable sac, by gestational age group
Measured: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group
Measured: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to excessive prolonged bleeding indicated as severe on the adverse event form, by gestational age group
Measured: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group
Measured: 2-4 weeks
Number of participants requiring an unscheduled clinic visit, by gestational age group
Measured: 2-4 weeks
Number of participants who called the helpline, by gestational age group
Measured: 2-4 weeks
Time to expulsion in days, by gestational age group
Measured: 2-4 weeks
Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group
Measured: 2-4 weeks
Duration of heavy bleeding, by gestational age group
Measured: 2-4 weeks
Duration of work or school missed, by gestational age group
Measured: 2-4 weeks
Pain reliever use
Measured: 2-4 weeks
Satisfied or very satisfied with abortion method, by gestational age group
Measured: 2-4 weeks
Would choose medical abortion again instead of surgical, by gestational age group
Measured: 2-4 weeks
Would recommend abortion method to a friend, by gestational age group
Measured: 2-4 weeks
Proportion of participants who saw products of pregnancy, by gestational age group
Measured: 2-4 weeks
Proportion of participants who saw products of pregnancy who reported feelings as: nothing/no feeling, relieved, sad, uncomfortable, other, by gestational group
Measured: 2-4 weeks
Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention
Measured: 2-4 weeks
Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention
Measured: 2-4 weeks
Did not receive a contraceptive method by follow-up visit, but don't want to get pregnant in next 12 months, by gestational age group
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2016
- 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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Medical 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibis Reproductive Health
- Sponsor type
- University, hospital or other
- Collaborators
- Marie Stopes International
- Responsible party
- Sponsor
- Investigators
- Daniel Grossman, MD, Principal investigator, Ibis Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745093
- Sponsor's protocol ID
- MSI-6103
- Status last verified
- Jun 2016
- First submitted
- 7 Aug 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boersma AA, Meyboom-de Jong B, Kleiverda G. Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of amenorrhoea in a general practice in Curacao. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):61-6. doi: 10.3109/13625187.2011.555568. Epub 2011 Feb 9.
PubMed 21303309Chen MJ, Creinin MD. Mifepristone With Buccal Misoprostol for Medical Abortion: A Systematic Review. Obstet Gynecol. 2015 Jul;126(1):12-21. doi: 10.1097/AOG.0000000000000897.
PubMed 26241251Gomperts R, van der Vleuten K, Jelinska K, da Costa CV, Gemzell-Danielsson K, Kleiverda G. Provision of medical abortion using telemedicine in Brazil. Contraception. 2014 Feb;89(2):129-33. doi: 10.1016/j.contraception.2013.11.005. Epub 2013 Nov 12.
PubMed 24314910Gouk EV, Lincoln K, Khair A, Haslock J, Knight J, Cruickshank DJ. Medical termination of pregnancy at 63 to 83 days gestation. Br J Obstet Gynaecol. 1999 Jun;106(6):535-9. doi: 10.1111/j.1471-0528.1999.tb08320.x.
PubMed 10426609Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks' gestation: a review of 1076 consecutive cases. Contraception. 2005 May;71(5):327-32. doi: 10.1016/j.contraception.2004.10.015.
PubMed 15854631Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005 Aug;112(8):1102-8. doi: 10.1111/j.1471-0528.2005.00638.x.
PubMed 16045525Kulier R, Kapp N, Gulmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD002855. doi: 10.1002/14651858.CD002855.pub4.
PubMed 22071804Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ. 2011 May 1;89(5):360-70. doi: 10.2471/BLT.10.084046. Epub 2011 Mar 4.
PubMed 21556304Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/
PubMed 23700650Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.
PubMed 23090524
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness, Safety, and Acceptability of Home-administered Medical Abortion at Gestational Age of 8 to ≤9 Weeks Versus >9 to ≤12 Weeks: A Prospective Cohort Study in Mexico City
- ClinicalTrials.gov ID
- NCT02745093
- Acronym / sponsor ID
- MSI-6103
- Conditions
- Medical Abortion
- Keywords
- Abortion induced, Patient Acceptance of Healthcare, safety, effectiveness, misoprostol, mifepristone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Ibis Reproductive HealthUniversity, hospital or other
- Collaborators
- Marie Stopes International
- Study start
- Sep 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Apr 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 purpose of this study is to assess the effectiveness, safety, and acceptability of home-administered medical abortion at gestational age of 8 to ≤9 weeks versus >9 to ≤12 weeks among a cohort of women in Mexico City.
Detailed description
Medical abortion represents an important alternative to surgical methods for termination of early pregnancy. In Mexico City, abortion is legal on request up to 12 weeks of gestation; however, medical abortion is currently only offered up to 10 weeks at Marie Stopes Mexico clinics. The World Health Organization guidelines state that medical abortion drugs may be used to terminate pregnancy up to a gestational age of 24 weeks in clinical settings, with recommended regimens differing by gestational age. However, data are lacking on the safety and effectiveness of home-based medical abortion regimens for pregnancy terminations between >9 and ≤12 weeks' gestation. Investigators propose a prospective cohort study with women between 8 and ≤9 weeks and >9 and ≤12 weeks of pregnancy at Marie Stopes Mexico clinics to compare the effectiveness, safety, and acceptability of mifepristone followed by home-based misoprostol use in these two gestational age groups. The information from this study will inform policy and practice guidelines in Mexico City and potentially other locations by providing evidence on the safety, effectiveness, and acceptability of home-use of medical abortion between >9 and ≤12 weeks of gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 64-84 days gestational age | Experimental | Drug: Mifepristone, Drug: MisoprostolWomen whose pregnancies are estimated to have a gestational age of 64-84 days will receive 200 µg mifepristone followed by misoprostol 24-48 hours later. |
| 57-63 days gestational age | No intervention | –Women whose pregnancies are estimated to have a gestational age of 57-63 days. (Women in this arm receive the standard of care for medical termination of pregnancy in the stated gestational age range: 200 µg mifepristone administered orally in the clinic on Day 1 then 800 μg misoprostol administered sublingually 24-48 hours later at home with a subsequent dose of 400 μg misoprostol sublingually 6 hours later if she has not expelled the pregnancy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 or older
- Intrauterine pregnancy 57- 84 days, assessed using clinical assessment and transvaginal or transabdominal ultrasound by crown-rump length (machines will be calibrated and will use a standardized conversion formula to determine gestational age)
- Eligible for medical abortion according to doctor assessment
- Elected medical abortion over surgical abortion after comprehensive counselling
- Haemoglobin level ≥10 g/dl measured by Hemocue
Key exclusion criteria (6 listed)
- History or evidence of disorders that represent a contraindication to the use of mifepristone or misoprostol (chronic adrenal failure, severe asthma uncontrolled by corticosteroid therapy, inherited porphyries, glaucoma, mitral stenosis, hepatic or renal disease)
- History of bleeding disorder or current anticoagulant therapy
- Previous allergic reaction to any drugs in the regimen
- Suspicion of any pathology of pregnancy (e.g. molar, ectopic, non-viable pregnancy)
- Multiple gestation
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 |
|---|---|---|
| MifepristoneWomen at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1. | Drug | 64-84 days gestational age |
| MisoprostolThe client will then be given a total of 2400 µg misoprostol tablets to take home, and will be instructed to take 800 μg misoprostol administered sublingually 24-48 hours later at home and to administer a subsequent dose of 400 μg misoprostol sublingually every 3 hours up to a total of four further doses or until expulsion of the products of conception, whichever comes first. | Drug | 64-84 days gestational age |
Primary outcome
Proportion of participants with complete abortion without surgical intervention by day 30 from mifepristone administration, regardless of misoprostol dosing, by gestational age group
Time frame: 2-4 weeks
22 secondary outcomes
Experience of any major adverse event overall, and by type (emergency room treatment, hospitalization, transfusion, unrecognized ectopic pregnancy, allergic reaction, infection requiring intravenous treatment, and death), by gestational age group
Time frame: 2-4 weeks
Proportion of participants by gestational age group with complete abortion without surgical intervention after 1, 2, 3, 4, and 5 doses of misoprostol, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to an ongoing pregnancy, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to the presence of a persistent non-viable sac, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to substantial debris in uterus, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to excessive prolonged bleeding indicated as severe on the adverse event form, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring surgical intervention to complete an abortion due to woman's request, by gestational age group
Time frame: 2-4 weeks
Number of participants requiring an unscheduled clinic visit, by gestational age group
Time frame: 2-4 weeks
Number of participants who called the helpline, by gestational age group
Time frame: 2-4 weeks
Time to expulsion in days, by gestational age group
Time frame: 2-4 weeks
Side effects overall and by type (chills, fever, vomiting, nausea, diarrhoea, and severe pain), by gestational age group
Time frame: 2-4 weeks
Duration of heavy bleeding, by gestational age group
Time frame: 2-4 weeks
Duration of work or school missed, by gestational age group
Time frame: 2-4 weeks
Pain reliever use
Time frame: 2-4 weeks
Satisfied or very satisfied with abortion method, by gestational age group
Time frame: 2-4 weeks
Would choose medical abortion again instead of surgical, by gestational age group
Time frame: 2-4 weeks
Would recommend abortion method to a friend, by gestational age group
Time frame: 2-4 weeks
Proportion of participants who saw products of pregnancy, by gestational age group
Time frame: 2-4 weeks
Proportion of participants who saw products of pregnancy who reported feelings as: nothing/no feeling, relieved, sad, uncomfortable, other, by gestational group
Time frame: 2-4 weeks
Received family planning by follow-up visit, by gestational age group / method type/ pregnancy intention
Time frame: 2-4 weeks
Know where to get contraceptive supplies in the future, by gestational age group and pregnancy intention
Time frame: 2-4 weeks
Did not receive a contraceptive method by follow-up visit, but don't want to get pregnant in next 12 months, by gestational age group
Time frame: 2-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Background: PubMed 21303309Boersma AA, Meyboom-de Jong B, Kleiverda G. Mifepristone followed by home administration of buccal misoprostol for medical abortion up to 70 days of amenorrhoea in a general practice in Curacao. Eur J Contracept Reprod Health Care. 2011 Apr;16(2):61-6. doi: 10.3109/13625187.2011.555568. Epub 2011 Feb 9.
- Background: PubMed 26241251Chen MJ, Creinin MD. Mifepristone With Buccal Misoprostol for Medical Abortion: A Systematic Review. Obstet Gynecol. 2015 Jul;126(1):12-21. doi: 10.1097/AOG.0000000000000897.
- Background: PubMed 24314910Gomperts R, van der Vleuten K, Jelinska K, da Costa CV, Gemzell-Danielsson K, Kleiverda G. Provision of medical abortion using telemedicine in Brazil. Contraception. 2014 Feb;89(2):129-33. doi: 10.1016/j.contraception.2013.11.005. Epub 2013 Nov 12.
- Background: PubMed 10426609Gouk EV, Lincoln K, Khair A, Haslock J, Knight J, Cruickshank DJ. Medical termination of pregnancy at 63 to 83 days gestation. Br J Obstet Gynaecol. 1999 Jun;106(6):535-9. doi: 10.1111/j.1471-0528.1999.tb08320.x.
- Background: PubMed 15854631Hamoda H, Ashok PW, Flett GM, Templeton A. Medical abortion at 9-13 weeks' gestation: a review of 1076 consecutive cases. Contraception. 2005 May;71(5):327-32. doi: 10.1016/j.contraception.2004.10.015.
- Background: PubMed 16045525Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation. BJOG. 2005 Aug;112(8):1102-8. doi: 10.1111/j.1471-0528.2005.00638.x.
- Background: PubMed 22071804Kulier R, Kapp N, Gulmezoglu AM, Hofmeyr GJ, Cheng L, Campana A. Medical methods for first trimester abortion. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD002855. doi: 10.1002/14651858.CD002855.pub4.
- Background: PubMed 21556304Ngo TD, Park MH, Shakur H, Free C. Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review. Bull World Health Organ. 2011 May 1;89(5):360-70. doi: 10.2471/BLT.10.084046. Epub 2011 Mar 4.
- Background: PubMed 23700650Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/
- Background: PubMed 23090524Winikoff B, Dzuba IG, Chong E, Goldberg AB, Lichtenberg ES, Ball C, Dean G, Sacks D, Crowden WA, Swica Y. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol. 2012 Nov;120(5):1070-6. doi: 10.1097/aog.0b013e31826c315f.
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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.
Daniel Grossman, MD principal investigator
Ibis Reproductive Health
3 sites 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 Medical Abortion, run by Ibis Reproductive Health at 3 sites in Mexico.
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 11 inclusion and 6 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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?
Contact Antonio Candelas (++ 52 55 5265 5041, antonio.candelas@mariestopes.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with complete abortion without surgical intervention by day 30 from mifepristone administration, regardless of misoprostol dosing, by gestational age group (time frame: 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745093, which also lists 10 linked publications.
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 20 Jun 2016.