Post Partum HemorrhagePhase 1NCT01863706
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
A Phase 1 study testing Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. Read more about this study
- Who is it for?
- Ages 10 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIran
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 1
- 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 10 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- were women with singleton pregnancy
- with cephalic presentation
- who had NVD spontaneously or by induction
Who cannot join
- placenta previa
- placental detachment
- coagulation problems
- previous CS
- macrosomia
- Polyhydramnios
- and uncontrolled asthma
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: Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.
Read the detailed description
In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Misoprostol, Oxytocin
- Keywords
- Misoprostol, Oxytocin, Post Partum Hemorrhage (PPH), Third stage of labour
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
400µg oral misoprostol
OxytocinDrug
Also called Syntocinon
20 IU Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | 400µg oral misoprostol Receives: Drug: Misoprostol |
| Oxytocin | Active comparator | 20 IU oxytocin Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bleeding
within 1 hours after delivery
Measured: 1 hour
Secondary outcomes (2)
Hemoglobin decrease
Measured: 24 hours
Hematocrite decrease
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
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 Post Partum HemorrhageStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
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
- Investigators
- Minoo Rajaei, Dr, Study chair, Hormozgan University of Medical SciencesZohreh Shahboodaghi, Dr, Study director, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863706
- Sponsor's protocol ID
- Misoprostol for PPH
- Status last verified
- Mar 2015
- First submitted
- 23 May 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rajaei M, Karimi S, Shahboodaghi Z, Mahboobi H, Khorgoei T, Rajaei F. Safety and efficacy of misoprostol versus oxytocin for the prevention of postpartum hemorrhage. J Pregnancy. 2014;2014:713879. doi: 10.1155/2014/713879. Epub 2014 Mar 5.
PubMed 24734184
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
- ClinicalTrials.gov ID
- NCT01863706
- Acronym / sponsor ID
- Misoprostol for PPH
- Conditions
- Post Partum Hemorrhage
- Keywords
- Misoprostol, Oxytocin, Post Partum Hemorrhage (PPH), Third stage of labour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 May 2013 (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.
Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.
Detailed description
In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol400µg oral misoprostol |
| Oxytocin | Active comparator | Drug: Oxytocin20 IU oxytocin |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- were women with singleton pregnancy
- with cephalic presentation
- who had NVD spontaneously or by induction
Key exclusion criteria (7 listed)
- placenta previa
- placental detachment
- coagulation problems
- previous CS
- macrosomia
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: Cytotec400µg oral misoprostol | Drug | Misoprostol |
| OxytocinAlso: Syntocinon20 IU Oxytocin | Drug | Oxytocin |
Primary outcome
Amount of bleeding
Time frame: 1 hour
within 1 hours after delivery
2 secondary outcomes
Hemoglobin decrease
Time frame: 24 hours
Hematocrite decrease
Time frame: 24 hours
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 26 Mar 2015.
- Derived from this study: PubMed 24734184Rajaei M, Karimi S, Shahboodaghi Z, Mahboobi H, Khorgoei T, Rajaei F. Safety and efficacy of misoprostol versus oxytocin for the prevention of postpartum hemorrhage. J Pregnancy. 2014;2014:713879. doi: 10.1155/2014/713879. Epub 2014 Mar 5.
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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.
Minoo Rajaei, Dr study chair
Hormozgan University of Medical Sciences
Zohreh Shahboodaghi, Dr study director
Hormozgan 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 1 study testing Misoprostol and Oxytocin in people with Post Partum Hemorrhage, 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 3 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 26 Mar 2015. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of bleeding (time frame: 1 hour). 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 NCT01863706, 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 26 Mar 2015.