Bleeding IntraoperativePhase 2/3NCT01477840
Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean
A Phase 2/3 study testing Misoprostol in people with Bleeding Intraoperative, run by Soudabeh Eshghi ali at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding Intraoperative
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIran
- Study dates
- Aug 2012to Aug 2012
- Phase
- Phase 2/3
- 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 15 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Indication of Cesarean Deliveries
- Elective or Emergency with Incision in Lower Segment in Women with
- Gestational Age more than 37 Weeks.
Who cannot join
- Anemia
- Multiple Pregnancy
- Polyhydraminus
- Prolonged Labor
- Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
- Hypertension
- Cardiovascular Disease
- Coagulopathy Disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
Kermanshah, Kermanshah Province, 67144-15333
Anisodowleh Nankali, MD, 98 831 4276310, anankali@kums.ac.ir
Soudabeh Eshghi Ali, MD
About this study
Official title: Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries
The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.
Read the detailed description
A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.
- Conditions
- Bleeding Intraoperative
- Being tested
- Misoprostol
- Keywords
- Misoprostol, Oxytocin, Cesarean Delivery, Blood Loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01
Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | Not described Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative bleeding
Measured: At the time of surgery
Secondary outcomes (5)
Fever
Measured: During 48 hours after surgery measured every 3 hours
Changing of pulse rate from base
Measured: Before surgery & intraoperative & 6 hours after surgery
Changing of blood pressure
Measured: Before surgery & intraoperative & 6 hours after surgery
Diarrhea
Measured: Before & 6 hours after surgery
Vomiting
Measured: Before & 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startAug 2012
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bleeding IntraoperativeStudies 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 2/3
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soudabeh Eshghi ali
- Sponsor type
- University, hospital or other
- Collaborators
- Kermanshah University of Medical Sciences
- Responsible party
- Sponsor-investigator, Soudabeh Eshghi ali, Kermanshah University of Medical Sciences
- Investigators
- Anisodowleh Nankali, MD, Study chair, Kermanshah University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477840
- Sponsor's protocol ID
- Kermanshah University
- Status last verified
- Dec 2011
- First submitted
- 31 Oct 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eftekhari N, Doroodian M, Lashkarizadeh R. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. J Obstet Gynaecol. 2009 Oct;29(7):633-6. doi: 10.1080/01443610903061744.
PubMed 19757270
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT01477840
- Acronym / sponsor ID
- Kermanshah University
- Conditions
- Bleeding Intraoperative
- Keywords
- Misoprostol, Oxytocin, Cesarean Delivery, Blood Loss
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Soudabeh Eshghi aliUniversity, hospital or other
- Collaborators
- Kermanshah University of Medical Sciences
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 23 Nov 2011 (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 the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.
Detailed description
A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Indication of Cesarean Deliveries
- Elective or Emergency with Incision in Lower Segment in Women with
- Gestational Age more than 37 Weeks.
Key exclusion criteria (8 listed)
- Anemia
- Multiple Pregnancy
- Polyhydraminus
- Prolonged Labor
- Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
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 |
|---|---|---|
| MisoprostolAlso: Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia | Drug | Misoprostol |
Primary outcome
Intraoperative bleeding
Time frame: At the time of surgery
5 secondary outcomes
Fever
Time frame: During 48 hours after surgery measured every 3 hours
Changing of pulse rate from base
Time frame: Before surgery & intraoperative & 6 hours after surgery
Changing of blood pressure
Time frame: Before surgery & intraoperative & 6 hours after surgery
Diarrhea
Time frame: Before & 6 hours after surgery
Vomiting
Time frame: Before & 6 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Results publication: PubMed 19757270Eftekhari N, Doroodian M, Lashkarizadeh R. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. J Obstet Gynaecol. 2009 Oct;29(7):633-6. doi: 10.1080/01443610903061744.
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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.
Anisodowleh Nankali, MD study chair
Kermanshah University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Misoprostol in people with Bleeding Intraoperative, run by Soudabeh Eshghi ali 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 3 inclusion and 8 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 13 Dec 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Anisodowleh Nankali, MD (98 831 4276310, anankali@kums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bleeding (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477840, which also lists 1 linked publication.
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 13 Dec 2011.