Abortion, IncompleteNCT00670761
Misoprostol for the Treatment of Incomplete Abortion
A study testing misoprostol and MVA in people with Abortion, Incomplete, run by Gynuity Health Projects at 6 sites in 5 countries.
Trial summary
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion. Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens: In Tanzania and Mozambique: 1. 600 mcg of oral misoprostol in one dose, or 2. 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
- Abortion, Incomplete
- What is being tested?
- misoprostol and MVA
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jul 2004to Dec 2010
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- If no ultrasound used:
- Past or present history of vaginal bleeding during pregnancy; and
- Open cervical os.
- If ultrasound used:
- Past or present history of vaginal bleeding during pregnancy; and
- Evidence of incomplete abortion with substantial debris in the uterus.
Show all 13Show fewer
- All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
- Willing to provide contact information for purposes of follow-up.
- In Tanzania: 18 years of age or over or parental permission
- In Mozambique: 21 years of age or over or parental permission
- In Moldova: 18 years of age or over
- In Madagascar: 18 years of age or parental permission
- In Vietnam: reproductive age
Who cannot join
- Contraindications to the study drug;
- Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
- Signs of severe infection, defined as at least one of the following of:
- foul smelling discharge,
- fever > 39 degrees C ,
- pulse >110/min;
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Burkina Faso2 sites
Hôpital de District Sanitaire Dandé
Bobo-Dioulasso
Hôpital de District Sanitaire de Ziniaré
Ouagadougou
About this study
Official title: Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:
In Tanzania and Mozambique:
- 600 mcg of oral misoprostol in one dose, or
- Standard surgical treatment (MVA)
In Moldova and Madagascar:
- 600 mcg of oral misoprostol in one dose, or
- 400 mcg of sublingual misoprostol in one dose.
In Burkina Faso and Vietnam:
- 400 mcg of sublingual misoprostol in one dose.
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
- Conditions
- Abortion, Incomplete
- Being tested
- misoprostol, MVA
- Keywords
- misoprostol, incomplete abortion, sublingual, postabortion care, MVA
- 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
Also called Cytotec
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
MVAProcedure or surgery
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | treatment with 600mcg oral misoprostol Receives: Drug: misoprostol |
| 2 | Active comparator | treatment with 400mcg sublingual misoprostol Receives: Drug: misoprostol |
| 3 | Active comparator | treatment with Manual Vacuum Aspiration (MVA) Receives: Procedure: MVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
Measured: one week after initial treatment with the option of an additional week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startJul 2004
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, IncompleteStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Befelatanana Maternity Centre, Municipal Clinical Hospital No. 1, Kagera Regional Hospital, Jose Macamo Hospital, Tudu hospital, National OBGYN hospital, Cuchi General District hospital, Hôpital de District Sanitaire Dandé, Hôpital de District Sanitaire de Ziniaré
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670761
- Sponsor's protocol ID
- 2.2.1
- Status last verified
- Jul 2016
- First submitted
- 29 Apr 2008
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ngoc NT, Shochet T, Blum J, Hai PT, Dung DL, Nhan TT, Winikoff B. Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting. BMC Pregnancy Childbirth. 2013 May 22;13:118. doi: 10.1186/1471-2393-13-118.
PubMed 23697561
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options
- ClinicalTrials.gov ID
- NCT00670761
- Acronym / sponsor ID
- 2.2.1
- Conditions
- Abortion, Incomplete
- Keywords
- misoprostol, incomplete abortion, sublingual, postabortion care, MVA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Befelatanana Maternity Centre, Municipal Clinical Hospital No. 1, Kagera Regional Hospital, Jose Macamo Hospital, Tudu hospital, National OBGYN hospital, Cuchi General District hospital, Hôpital de District Sanitaire Dandé, Hôpital de District Sanitaire de Ziniaré
- Study start
- Jul 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 May 2008 (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.
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:
In Tanzania and Mozambique:
- 600 mcg of oral misoprostol in one dose, or
- Standard surgical treatment (MVA)
In Moldova and Madagascar:
- 600 mcg of oral misoprostol in one dose, or
- 400 mcg of sublingual misoprostol in one dose.
In Burkina Faso and Vietnam:
- 400 mcg of sublingual misoprostol in one dose.
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: misoprostoltreatment with 600mcg oral misoprostol |
| 2 | Active comparator | Drug: misoprostoltreatment with 400mcg sublingual misoprostol |
| 3 | Active comparator | Procedure: MVAtreatment with Manual Vacuum Aspiration (MVA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- If no ultrasound used:
- If ultrasound used:
- All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
- Willing to provide contact information for purposes of follow-up.
Key exclusion criteria (6 listed)
- Contraindications to the study drug;
- Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
- Signs of severe infection, defined as at least one of the following of:
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 |
|---|---|---|
| misoprostolAlso: Cytoteccomparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA) | Drug | 1, 2 |
| MVAcomparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA) | Procedure or surgery | 3 |
Primary outcome
complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
Time frame: one week after initial treatment with the option of an additional week
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 27 Jul 2016.
- Derived from this study: PubMed 23697561Ngoc NT, Shochet T, Blum J, Hai PT, Dung DL, Nhan TT, Winikoff B. Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting. BMC Pregnancy Childbirth. 2013 May 22;13:118. doi: 10.1186/1471-2393-13-118.
Related trials for Abortion, Incomplete
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
RecruitingPhase 4
Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage
Miscarriage in First Trimester, Missed Miscarriage
Not yet recruiting
Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage
Silent Miscarriage
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
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 MVA in people with Abortion, Incomplete, 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 13 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: finished, as of the sponsor's last update on 27 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 6 sites in Burkina Faso, Madagascar, Moldova, Mozambique, Tanzania. 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 resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason (time frame: one week after initial treatment with the option of an additional week). 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 NCT00670761, which also lists 1 linked publication.
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 27 Jul 2016.