Incomplete AbortionPhase 1NCT01539408
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria
A Phase 1 study testing Misoprostol and surgery Manual vacuum aspiration (MVA) in people with Incomplete Abortion, run by Gynuity Health Projects at 2 sites in Nigeria.
Trial summary
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Incomplete Abortion
- What is being tested?
- Misoprostol and surgery Manual vacuum aspiration (MVA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesNigeria
- Study dates
- Aug 2009to Oct 2010
- Phase
- Phase 1
- 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
- no contraindications to misoprostol
- uterine size was not larger than 12 weeks
- there were no signs of severe infection
- haemodynamically stable
- in general good health
- willing to provide contact information
Who cannot join
- an IUD in place
- ectopic pregnancy
- aged below 18 years and had no accompanying adult to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Adeoyo Maternity Hospital
Ibadan
University College Hospital, Ibadan
Ibadan
About this study
Official title: Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.
- Conditions
- Incomplete Abortion
- Being tested
- Misoprostol, surgery Manual vacuum aspiration (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
single dose of 400 mcg misoprostol administered sublingually
surgery Manual vacuum aspiration (MVA)Procedure or surgery
standard surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | 400 mcg of sublingual misoprostol in one dose Receives: Drug: Misoprostol |
| Manual vacuum aspiration (MVA) | Active comparator | Standard surgical treatment (MVA) Receives: Procedure: surgery Manual vacuum aspiration (MVA) |
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 Feb 2012 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539408
- Sponsor's protocol ID
- 2.2.3
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2012
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 23150927Fawole AO, Diop A, Adeyanju AO, Aremu OT, Winikoff B. Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria. Int J Gynaecol Obstet. 2012 Nov;119(2):170-3. doi: 10.1016/j.ijgo.2012.06.012. Epub 2012 Aug 27.
PubMed 22935620
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 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
- NCT01539408
- Acronym / sponsor ID
- 2.2.3
- Conditions
- Incomplete Abortion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Feb 2012 (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.
Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: Misoprostol400 mcg of sublingual misoprostol in one dose |
| Manual vacuum aspiration (MVA) | Active comparator | Procedure: surgery Manual vacuum aspiration (MVA)Standard surgical treatment (MVA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- no contraindications to misoprostol
- uterine size was not larger than 12 weeks
- there were no signs of severe infection
- haemodynamically stable
- in general good health
Key exclusion criteria (3 listed)
- an IUD in place
- ectopic pregnancy
- aged below 18 years and had no accompanying adult to provide informed consent
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 |
| surgery Manual vacuum aspiration (MVA)standard surgical treatment | Procedure or surgery | Manual vacuum aspiration (MVA) |
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 27 Feb 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 22935620Fawole AO, Diop A, Adeyanju AO, Aremu OT, Winikoff B. Misoprostol as first-line treatment for incomplete abortion at a secondary-level health facility in Nigeria. Int J Gynaecol Obstet. 2012 Nov;119(2):170-3. doi: 10.1016/j.ijgo.2012.06.012. Epub 2012 Aug 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Misoprostol and surgery Manual vacuum aspiration (MVA) in people with Incomplete Abortion, run by Gynuity Health Projects at 2 sites in Nigeria.
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 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 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT01539408, which also lists 3 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 27 Feb 2012.