Postpartum Hemorrhage Prevention by Using Oxytocin Verses MisoprostolNCT01612390
Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor
An observational study of Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol, run by Rasha Mohammed Mohammed Badawi at 1 site in Egypt.
Trial summary
Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2012to Dec 2013
- Phase
- Observational
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will include (180)randomly allocated
Who may be able to join
- Women with aheathy singleton pregnancy in spontaneous or induced labor at term .
Who cannot join
- Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin<7g/dl)
Trial locations and contacts
1 site in 1 country.
Rasha mohamed, M.B;B.CH contact
About this study
Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor
Read the detailed description
Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration
- Keywords
- postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | receive 400 Mg sublingual misoprostol. | |
| group 2 | receive 600 Mg sublingual misoprostol. | |
| group 3 | receive 5IU of intravenous oxytocin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduce blood loss during third and fourth stages of labor.
reduce blood loss during third and fourth stages of labor by using misopristol is better than using oxytocin
Measured: 1 year
Secondary outcomes (1)
the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs
the duration of the third stage of labor ,needed for oxytocics ,blood transfusion and any adverse effects of the drug will be reduced with mesopristol
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage Prevention by Using Oxytocin Verses MisoprostolStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rasha Mohammed Mohammed Badawi
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Rasha Mohammed Mohammed Badawi, Ain Shams University
- Investigators
- RBadawi mohamed, M.B;B.CH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612390
- Sponsor's protocol ID
- hit 1234
- Status last verified
- Jun 2012
- First submitted
- 2 Jun 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor
- ClinicalTrials.gov ID
- NCT01612390
- Acronym / sponsor ID
- hit 1234
- Keywords
- postpartum hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rasha Mohammed Mohammed BadawiUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Jun 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.
Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor
Detailed description
Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –receive 400 Mg sublingual misoprostol. |
| group 2 | – | –receive 600 Mg sublingual misoprostol. |
| group 3 | – | –receive 5IU of intravenous oxytocin. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include (180)randomly allocated
Key inclusion criteria (1 listed)
- Women with aheathy singleton pregnancy in spontaneous or induced labor at term .
Key exclusion criteria (1 listed)
- Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin<7g/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reduce blood loss during third and fourth stages of labor.
Time frame: 1 year
reduce blood loss during third and fourth stages of labor by using misopristol is better than using oxytocin
1 secondary outcome
the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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.
Rasha mohamed, M.B;B.CH contact
RBadawi mohamed, M.B;B.CH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol, run by Rasha Mohammed Mohammed Badawi at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 5 Jun 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rasha mohamed, M.B;B.CH (abosalma_82@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduce blood loss during third and fourth stages of labor. (time frame: 1 year). 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 5 Jun 2012.