TerminationNCT01508143
Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination
A study testing Misoprostol 400 micrograms and Misoprostol 800 micrograms in people with Termination, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to compare two misoprostol regimen in pregnancy termination. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Termination
- What is being tested?
- Misoprostol 400 micrograms and Misoprostol 800 micrograms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIran
- Study dates
- Jan 2012to Sep 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
- Before 14th week of gestation calculated according LMP or first trimester sonography
Who cannot join
- Chorioamnionitis
- Hypersensitivity to prosstaglandins
- Past medical history of cardiovascular, kidney or liver or lung diseases
- Positive history for uterus pathologies
- suspicious to extra-uterus pregnancy
- sign and symptoms of uterus infection
- Molar pregnancy
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 097145-3388
About this study
Official title: A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009
The aim of this study is to compare two misoprostol regimen in pregnancy termination.
Read the detailed description
Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.
- Conditions
- Termination
- Being tested
- Misoprostol 400 micrograms, Misoprostol 800 micrograms
- Keywords
- Abortion, Pregnancy, Termination, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 400 microgramsDrug
Also called Cytotec
Misoprostol 400 micrograms each 6 hours for 8 dose
Misoprostol 800 microgramsDrug
Also called Cytotec
Misoprostol 800 micrograms each 12 hours for 4 doses
| Study group | Role | What they receive |
|---|---|---|
| 400 microgram misoprostol | Experimental | 400 micrograms misoprostol each 6 hours for 8 dose Receives: Drug: Misoprostol 400 micrograms |
| 800 micrograms misoprostol | Active comparator | 800 micrograms misoprostol each 12 hours for 4 dose Receives: Drug: Misoprostol 800 micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abortion
After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion.
Measured: 48 hours after treatment
Secondary outcomes (3)
Duration of abortion
Duration of abortion Form the begining of treatment to complete abortion
Measured: Form the begining of treatment to complete abortion
Adverse Effects
including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash
Measured: 48 hours after treatment
Need for surgery
Dilatation \& cartage
Measured: 48 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TerminationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Mahboobi, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508143
- Sponsor's protocol ID
- Misoprostol in termination
- Status last verified
- Sep 2012
- First submitted
- 9 Jan 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009
- ClinicalTrials.gov ID
- NCT01508143
- Acronym / sponsor ID
- Misoprostol in termination
- Conditions
- Termination
- Keywords
- Abortion, Pregnancy, Termination, Misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jan 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.
The aim of this study is to compare two misoprostol regimen in pregnancy termination.
Detailed description
Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 microgram misoprostol | Experimental | Drug: Misoprostol 400 micrograms400 micrograms misoprostol each 6 hours for 8 dose |
| 800 micrograms misoprostol | Active comparator | Drug: Misoprostol 800 micrograms800 micrograms misoprostol each 12 hours for 4 dose |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
- Before 14th week of gestation calculated according LMP or first trimester sonography
Key exclusion criteria (7 listed)
- Chorioamnionitis
- Hypersensitivity to prosstaglandins
- Past medical history of cardiovascular, kidney or liver or lung diseases
- Positive history for uterus pathologies
- suspicious to extra-uterus pregnancy
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 400 microgramsAlso: CytotecMisoprostol 400 micrograms each 6 hours for 8 dose | Drug | 400 microgram misoprostol |
| Misoprostol 800 microgramsAlso: CytotecMisoprostol 800 micrograms each 12 hours for 4 doses | Drug | 800 micrograms misoprostol |
Primary outcome
Abortion
Time frame: 48 hours after treatment
After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion.
3 secondary outcomes
Duration of abortion
Time frame: Form the begining of treatment to complete abortion
Adverse Effects
Time frame: 48 hours after treatment
Need for surgery
Time frame: 48 hours after 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 2 Oct 2012.
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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.
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 400 micrograms and Misoprostol 800 micrograms in people with Termination, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 7 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 2 Oct 2012. 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 Iran. 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?
Abortion (time frame: 48 hours after treatment). 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 2 Oct 2012.