Incomplete AbortionNCT00466999
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
A study testing misoprostol and surgery in people with Incomplete Abortion, run by Gynuity Health Projects at 6 sites in 5 countries.
Trial summary
In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incomplete Abortion
- What is being tested?
- misoprostol and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Feb 2007to Nov 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Uterine size no larger than 12 weeks LMP at time of presentation for care.
- Past or present history of vaginal bleeding during pregnancy.
- Open cervical os.
- If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
- All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
- General good health.
- Willing to provide contact information for purposes of follow-up.
- Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).
Who cannot join
- Contraindications to study drug
- Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
- Hemodynamic disturbances (pulse >110/min and systolic bp <100)
- Have an IUD in place; (the IUD may be removed making the woman eligible)
- Suspected ectopic pregnancy
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Egypt2 sites
El-Galaa Teaching Hospital
Cairo
Shatby Maternity Hospital/Alexandria University
Shatby, Alexandria
Burkina Faso1 site
Dandé District Hospital/Ziniaré District Hospital
Dande/Ziniare
Mauritania1 site
Cheikh Zayed Hospital
Nouakchott
About this study
In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.
- Conditions
- Incomplete Abortion
- Being tested
- misoprostol, surgery
- Keywords
- misoprostol, incomplete abortion, PAC
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
single dose of 400 mcg misoprostol administered sublingually
surgeryProcedure or surgery
standard surgical treatment (dilation and curettage or manual vacuum aspiration)
| Study group | Role | What they receive |
|---|---|---|
| surgery | Active comparator | standard surgical treatment (either dilation and curettage or manual vacuum aspiration) Receives: Procedure: surgery |
| misoprostol | Active comparator | 400 mcg misoprostol Receives: Drug: misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion without recourse to surgical intervention.
Measured: follow up visit 7 days after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Incomplete 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsRasha Dabash, MPH, Study director, Gynuity Health ProjectsAyisha Diop, MPH, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466999
- Sponsor's protocol ID
- 2.2.2
- Status last verified
- Mar 2012
- First submitted
- 25 Apr 2007
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
PubMed 34061352Shochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127.
PubMed 23150927Blandine T, Ouattara AZ, Coral A, Hassane C, Clotaire H, Dao B, Lankoande J, Diop A, Blum J. Sublingual [corrected] misoprostol as first-line care for incomplete abortion in Burkina Faso. Int J Gynaecol Obstet. 2012 Nov;119(2):166-9. doi: 10.1016/j.ijgo.2012.05.036. Epub 2012 Aug 28.
PubMed 22935621Dabash R, Ramadan MC, Darwish E, Hassanein N, Blum J, Winikoff B. A randomized controlled trial of 400-mug sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. Int J Gynaecol Obstet. 2010 Nov;111(2):131-5. doi: 10.1016/j.ijgo.2010.06.021.
PubMed 20801444
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
- ClinicalTrials.gov ID
- NCT00466999
- Acronym / sponsor ID
- 2.2.2
- Conditions
- Incomplete Abortion
- Keywords
- misoprostol, incomplete abortion, PAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Apr 2007 (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.
In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Active comparator | Procedure: surgerystandard surgical treatment (either dilation and curettage or manual vacuum aspiration) |
| misoprostol | Active comparator | Drug: misoprostol400 mcg misoprostol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Uterine size no larger than 12 weeks LMP at time of presentation for care.
- Past or present history of vaginal bleeding during pregnancy.
- Open cervical os.
- If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
- All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
Key exclusion criteria (5 listed)
- Contraindications to study drug
- Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
- Hemodynamic disturbances (pulse >110/min and systolic bp <100)
- Have an IUD in place; (the IUD may be removed making the woman eligible)
- Suspected ectopic pregnancy
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 |
|---|---|---|
| misoprostolsingle dose of 400 mcg misoprostol administered sublingually | Drug | misoprostol |
| surgerystandard surgical treatment (dilation and curettage or manual vacuum aspiration) | Procedure or surgery | surgery |
Primary outcome
Complete abortion without recourse to surgical intervention.
Time frame: follow up visit 7 days after initial treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Derived from this study: PubMed 34061352Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
- Derived from this study: PubMed 23150927Shochet T, Diop A, Gaye A, Nayama M, Sall AB, Bukola F, Blandine T, Abiola OM, Dao B, Olayinka O, Winikoff B. Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries. BMC Pregnancy Childbirth. 2012 Nov 14;12:127. doi: 10.1186/1471-2393-12-127.
- Derived from this study: PubMed 22935621Blandine T, Ouattara AZ, Coral A, Hassane C, Clotaire H, Dao B, Lankoande J, Diop A, Blum J. Sublingual [corrected] misoprostol as first-line care for incomplete abortion in Burkina Faso. Int J Gynaecol Obstet. 2012 Nov;119(2):166-9. doi: 10.1016/j.ijgo.2012.05.036. Epub 2012 Aug 28.
- Derived from this study: PubMed 20801444Dabash R, Ramadan MC, Darwish E, Hassanein N, Blum J, Winikoff B. A randomized controlled trial of 400-mug sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. Int J Gynaecol Obstet. 2010 Nov;111(2):131-5. doi: 10.1016/j.ijgo.2010.06.021.
- Related InfoLink provided by the sponsor.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Rasha Dabash, MPH study director
Gynuity Health Projects
Ayisha Diop, MPH study director
Gynuity Health Projects
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing misoprostol and surgery in people with Incomplete Abortion, run by Gynuity Health Projects at 6 sites in 5 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Egypt, Burkina Faso, Mauritania, Niger, Senegal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete abortion without recourse to surgical intervention. (time frame: follow up visit 7 days after initial treatment). 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 NCT00466999, which also lists 4 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 30 Mar 2012.