Incomplete AbortionNCT00674232
Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
A study testing 600 mcg misoprostol and Surgical treatment in people with Incomplete Abortion, run by Gynuity Health Projects at 3 sites in 2 countries.
Trial summary
This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Incomplete Abortion
- What is being tested?
- 600 mcg misoprostol and Surgical treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2006to Oct 2007
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- past or present history of vaginal bleeding during pregnancy
- open cervical os
- evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
- surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
- generally in good health
- woman lives or works within one hour of study site
- woman willing to provide contact information for follow up purposes
- informed consent given
Who cannot join
- contraindications to study drug
- uterine size larger than 12 weeks LMP
- signs of severe infection
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Ecuador2 sites
Hospital del Dia, CEMOPLAF
Quito
Hospital Gineco-obstetrico Isidro Ayora
Quito
About this study
Official title: Misoprostol for Treatment of Incomplete Abortion
This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.
- Conditions
- Incomplete Abortion
- Being tested
- 600 mcg misoprostol, Surgical treatment
- Keywords
- incomplete abortion, spontaneous miscarriage
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
600 mcg misoprostolDrug
Also called Cytotec
single dose of misoprostol taken orally
Surgical treatmentProcedure or surgery
Also called D&C, MVA
Either dilation and curettage or manual vacuum aspiration, as per local protocol
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | Group 1 randomized to take single dose of 600 mcg oral misoprostol Receives: Drug: 600 mcg misoprostol |
| Surgical treatment | Other | Group 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA) Receives: Procedure: Surgical treatment |
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
Secondary outcomes (2)
side effects
Measured: measured at follow up visit one week after initial treatment
acceptability
Measured: measured at follow up visit one week 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 posted7 May 2008 (estimated)
- Study startMay 2006
- Study completionOct 2007
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Investigators
- Melanie Peña, MPH, MA, Study director, Gynuity Health ProjectsJill Durocher, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674232
- Sponsor's protocol ID
- 2.2.0
- Status last verified
- May 2008
- First submitted
- 28 Apr 2008
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Montesinos R, Durocher J, Leon W, Arellano M, Pena M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. doi: 10.1016/j.ijgo.2011.06.015. Epub 2011 Aug 26.
PubMed 21872244
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for Treatment of Incomplete Abortion
- ClinicalTrials.gov ID
- NCT00674232
- Acronym / sponsor ID
- 2.2.0
- Conditions
- Incomplete Abortion
- Keywords
- incomplete abortion, spontaneous miscarriage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 7 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 study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: 600 mcg misoprostolGroup 1 randomized to take single dose of 600 mcg oral misoprostol |
| Surgical treatment | Other | Procedure: Surgical treatmentGroup 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA) |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- past or present history of vaginal bleeding during pregnancy
- open cervical os
- evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
- surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
- generally in good health
Key exclusion criteria (3 listed)
- contraindications to study drug
- uterine size larger than 12 weeks LMP
- signs of severe infection
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 |
|---|---|---|
| 600 mcg misoprostolAlso: Cytotecsingle dose of misoprostol taken orally | Drug | Misoprostol |
| Surgical treatmentAlso: D&C, MVAEither dilation and curettage or manual vacuum aspiration, as per local protocol | Procedure or surgery | Surgical treatment |
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
2 secondary outcomes
side effects
Time frame: measured at follow up visit one week after initial treatment
acceptability
Time frame: measured at follow up visit one week 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 7 May 2008.
- Derived from this study: PubMed 21872244Montesinos R, Durocher J, Leon W, Arellano M, Pena M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. doi: 10.1016/j.ijgo.2011.06.015. Epub 2011 Aug 26.
- Related InfoLink provided by the sponsor.
Related trials for Incomplete Abortion
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.
Melanie Peña, MPH, MA study director
Gynuity Health Projects
Jill Durocher study director
Gynuity Health Projects
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 600 mcg misoprostol and Surgical treatment in people with Incomplete Abortion, run by Gynuity Health Projects at 3 sites in 2 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 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: finished, as of the sponsor's last update on 7 May 2008. 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 Ecuador, Venezuela. 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). 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 NCT00674232, 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 7 May 2008.