Missed AbortionPhase 2NCT00892229
Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil
A Phase 2 study testing Misoprostol (given buccally) and Misoprostol (given vaginally) in people with Missed Abortion, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Misoprostol (given buccally) and Misoprostol (given vaginally)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- Mar 2007to Mar 2008
- Phase
- Phase 2
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- first trimester missed abortion
Who cannot join
- history or evidence of disorders that represent contraindication to the use of misoprostol:
- severe pulmonary diseases
- congenital or acquired heart diseases
- glaucoma
- prolonged use of corticosteroid
- sickle cell anemia and adrenal insufficiency
Show all 15Show fewer
- smokers
- known hypersensitivity to drugs
- any evidence of infection
- patient's refusal to participate in the study
- patients with abnormal results of investigations
- patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage
- patients with complete abortion
- patients with severe bleeding that required emergency surgical evacuation of the uterus
- patients with partially dissolved tablets at the site of application in both groups
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil
The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.
- Conditions
- Missed Abortion
- Being tested
- Misoprostol (given buccally), Misoprostol (given vaginally)
- Keywords
- First trimester missed abortion, Misoprostol, buccal, vaginal, cervical ripening, first trimester, missed abortion
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol (given buccally)Drug
Also called serial number 022-00
400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
Misoprostol (given vaginally)Drug
Also called serial number 022-00
400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms)
| Study group | Role | What they receive |
|---|---|---|
| Buccal Misoprostol | Active comparator | Group one: 50 patients with first trimester missed abortion received buccal misoprostol Receives: Drug: Misoprostol (given buccally) |
| Vaginal Misoprostol | Active comparator | Group two: 5 patients received vaginal misoprostol Receives: Drug: Misoprostol (given vaginally) |
| Buccal and Vaginal Misoprostol | Active comparator | 50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects.
Each group was randomly allocated (1,3,5,... for the buccal group \& 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol. Receives: Drug: Misoprostol (given buccally); Drug: Misoprostol (given vaginally) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)
Measured: March 2007 to March 2008
Secondary outcomes (1)
The secondary objectives are to compare the side effects and acceptability by the subjects.
Measured: March 2007 to March 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- NEGATIVE
- Investigators
- BASHAR Y F HANOOSHI, CABOG, Principal investigator, IRAQI MEDICAL SPECIALIZATION/IRAQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892229
- Sponsor's protocol ID
- IMS - 1769
- Status last verified
- May 2009
- First submitted
- 1 May 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Versus Vaginal Misoprostol for Cervical Ripening Prior to Surgical Termination of the First Trimester Missed Abortion in Erbil
- ClinicalTrials.gov ID
- NCT00892229
- Acronym / sponsor ID
- IMS - 1769
- Conditions
- Missed Abortion
- Keywords
- First trimester missed abortion, Misoprostol, buccal, vaginal, cervical ripening, first trimester, missed abortion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Collaborators
- NEGATIVE
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 May 2009 (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 determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buccal Misoprostol | Active comparator | Drug: Misoprostol (given buccally)Group one: 50 patients with first trimester missed abortion received buccal misoprostol |
| Vaginal Misoprostol | Active comparator | Drug: Misoprostol (given vaginally)Group two: 5 patients received vaginal misoprostol |
| Buccal and Vaginal Misoprostol | Active comparator | Drug: Misoprostol (given buccally), Drug: Misoprostol (given vaginally)50 primiparous and 50 multiparous women: one hundred patients have been administered the medication buccally (25 primigravida and 25 multigravida), and vaginally (25 primigravida and 25 multigravida), three hours before dilation and curettage. They were admitted to the hospital one day before the surgical evacuation, and preparation of cross matched blood done for all recruited subjects. Each group was randomly allocated (1,3,5,... for the buccal group \& 2,4,6,... for the vaginal group) to receive 400 microgram misoprostol. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first trimester missed abortion
Key exclusion criteria (15 listed)
- history or evidence of disorders that represent contraindication to the use of misoprostol:
- patient's refusal to participate in the study
- patients with abnormal results of investigations
- patients with previous operations on cervix like conisation, cauterization, previous dilatation and curettage
- patients with complete abortion
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 |
|---|---|---|
| Misoprostol (given buccally)Also: serial number 022-00400 microgram misoprostol given buccally three hours before dilation and curettage (PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms) | Drug | Buccal Misoprostol, Buccal and Vaginal Misoprostol |
| Misoprostol (given vaginally)Also: serial number 022-00400 microgram misoprostol (MISOPROSTOL - PHARMACIA CORPORATION - Istanbul, serial number 022-00, a tablet contains 200 micrograms) | Drug | Buccal and Vaginal Misoprostol, Vaginal Misoprostol |
Primary outcome
To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.)
Time frame: March 2007 to March 2008
1 secondary outcome
The secondary objectives are to compare the side effects and acceptability by the subjects.
Time frame: March 2007 to March 2008
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 4 May 2009.
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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.
BASHAR Y F HANOOSHI, CABOG principal investigator
IRAQI MEDICAL SPECIALIZATION/IRAQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol (given buccally) and Misoprostol (given vaginally) in people with Missed Abortion, run by Hawler Medical University at 1 site in Iraq.
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 1 inclusion and 15 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 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To compare the efficacy of buccal administration to the more commonly vaginal route for preoperative cervical and priming in patients with first trimester surgical abortion. (Buccal Vs. Vaginal Misoprostol in the First Trimester Missed Abortion.) (time frame: March 2007 to March 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2009.