MiscarriageNCT00797693
Misoprostol in Termination of First Trimester Missed Abortion
A study testing Misoprostol ( Cytotec) 200 microgram a tablet in people with Miscarriage, run by Hawler Medical University at 1 site in Iraq.
Trial summary
The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- Misoprostol ( Cytotec) 200 microgram a tablet
- 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
- Jan 2008to May 2008
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients were cases of first trimester missed abortion.
- They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.
Who cannot join
- Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Versus Vaginal Misoprostol as Cervical Ripening Agent Prior to Surgical Termination of First Trimester Missed Abortions in Hawler Maternity Teaching Hospital in Erbil/Iraq
The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.
Read the detailed description
Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical termination of first trimester missed abortion as cervical priming agent , the difference of cervical dilatation immediately prior to operation , the duration of operation and side effects between two treatment groups.
Design: This study was conducted as randomised study.
Setting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.
Population: Over a period of six months from the first of January to the thirtieth of June, 2008, one hundred women were included in this study. They were cases of first trimester abortion (6-12 weeks).
Method: Patients were randomly selected for the type of treatment they received. The first group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative cervical priming agent, where as the second group (vaginal) were allocated to have treatment either with vaginal misoprostol to receive 400 micrograms vaginally.
Main outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to termination of first trimester missed abortion.
Keywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.
- Conditions
- Miscarriage
- Being tested
- Misoprostol ( Cytotec) 200 microgram a tablet
- Keywords
- First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal, first trimester missed abortion
- Medical subject headings
- Abortion, Spontaneous, Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol ( Cytotec) 200 microgram a tabletDrug
Also called PHARMACIA CORPORATION - Istanbul, serial number 022-00, 200 microgram a tablet
In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Misoprostol | Experimental | A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix Receives: Drug: Misoprostol ( Cytotec) 200 microgram a tablet |
| Oral Misoprostol | Experimental | A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix Receives: Drug: Misoprostol ( Cytotec) 200 microgram a tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation
Measured: 6 months
Secondary outcomes (1)
Higher patient satisfaction for self administered oral misoprostol at home
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HAWLER Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797693
- Sponsor's protocol ID
- 324/2
- Status last verified
- Nov 2008
- First submitted
- 21 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Vaginal Misoprostol as Cervical Ripening Agent Prior to Surgical Termination of First Trimester Missed Abortions in Hawler Maternity Teaching Hospital in Erbil/Iraq
- ClinicalTrials.gov ID
- NCT00797693
- Acronym / sponsor ID
- 324/2
- Conditions
- Miscarriage
- Keywords
- First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal, first trimester missed abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Collaborators
- HAWLER Maternity Hospital
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Nov 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.
The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.
Detailed description
Objective: To compare the effectiveness of oral versus vaginal misoprostol prior to surgical termination of first trimester missed abortion as cervical priming agent , the difference of cervical dilatation immediately prior to operation , the duration of operation and side effects between two treatment groups.
Design: This study was conducted as randomised study.
Setting: Maternity Teaching Hospital in Hawler/ Kurdistan/ Iraq.
Population: Over a period of six months from the first of January to the thirtieth of June, 2008, one hundred women were included in this study. They were cases of first trimester abortion (6-12 weeks).
Method: Patients were randomly selected for the type of treatment they received. The first group (oral) were assigned to receive 400 micrograms of misoprostol orally as preoperative cervical priming agent, where as the second group (vaginal) were allocated to have treatment either with vaginal misoprostol to receive 400 micrograms vaginally.
Main outcome measure: Oral versus vaginal misoprostol as cervical ripening agent prior to termination of first trimester missed abortion.
Keywords: First trimester, missed abortion, misoprostol, cervical ripening, oral, vaginal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Misoprostol | Experimental | Drug: Misoprostol ( Cytotec) 200 microgram a tabletA drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix |
| Oral Misoprostol | Experimental | Drug: Misoprostol ( Cytotec) 200 microgram a tabletA drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients were cases of first trimester missed abortion.
- They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.
Key exclusion criteria (1 listed)
- Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.
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 ( Cytotec) 200 microgram a tabletAlso: PHARMACIA CORPORATION - Istanbul, serial number 022-00, 200 microgram a tabletIn this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix. | Drug | Oral Misoprostol, Vaginal Misoprostol |
Primary outcome
Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation
Time frame: 6 months
1 secondary outcome
Higher patient satisfaction for self administered oral misoprostol at home
Time frame: 6 months
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 25 Nov 2008.
Related trials for Miscarriage
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Recruiting
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Early Pregnancy Bleeding
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol ( Cytotec) 200 microgram a tablet in people with Miscarriage, 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 2 inclusion and 1 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 25 Nov 2008. 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.
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?
Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation (time frame: 6 months). 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 25 Nov 2008.