PreeclampsiaPhase 1/2NCT00432588
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies
A Phase 1/2 study testing misoprostol and dinoprostone in people with Preeclampsia and Fetal Death, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia, Fetal Death, Fetal Membranes, Premature Rupture
- What is being tested?
- misoprostol and dinoprostone
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- Term pregnancy
- Singleton
- Vertex
- Bishop score below 6
Who cannot join
- History of drug reaction
- Medical disease
- IUGR
- Oligohydramnios
- Vaginal bleeding
- Fetal anomaly
- Uterine scar
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shariaty Maternity Hospital
Tehran
Mitra Ahmad Soltani, MD, 0098 021 22301004, m_a_sol@yahoo.com
About this study
Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).
- Being tested
- misoprostol, dinoprostone
- Keywords
- IUFD, POSTTERM, ROM
- Medical subject headings
- Pre-Eclampsia, Fetal Death, Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
dinoprostoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mitra Ahmad Soltani, Principal investigator, Hormozgan University of Medical SciencesMinoo Rajaee Lari, Perinatologist - Obs and Gyn, Study chair, Department of Obs and Gyn - HUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432588
- Sponsor's protocol ID
- Misoprostol vs Dinoprostone
- Status last verified
- Feb 2007
- First submitted
- 6 Feb 2007
- Last updated
- 1 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies
- ClinicalTrials.gov ID
- NCT00432588
- Acronym / sponsor ID
- Misoprostol vs Dinoprostone
- Keywords
- IUFD, POSTTERM, ROM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- First posted
- 8 Feb 2007 (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.
Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Term pregnancy
- Singleton
- Vertex
- Bishop score below 6
Key exclusion criteria (7 listed)
- History of drug reaction
- Medical disease
- IUGR
- Oligohydramnios
- Vaginal bleeding
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 | Drug | – |
| dinoprostone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2007.
- Related InfoLink provided by the sponsor.
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Mitra Ahmad Soltani principal investigator
Hormozgan University of Medical Sciences
Minoo Rajaee Lari, Perinatologist - Obs and Gyn study chair
Department of Obs and Gyn - HUMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing misoprostol and dinoprostone in people with Preeclampsia and Fetal Death, 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 4 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: status not confirmed, as of the sponsor's last update on 1 Jun 2007. 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.
What does this combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 1 Jun 2007.