Post Partum HemorrhagePhase 3NCT03148574
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery
A Phase 3 study testing Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by Assiut University at 1 site in Egypt.
Trial summary
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2017to 15 Dec 2019
- Phase
- Phase 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.
- 3-Had no history of coagulopathy. 4-Accepting to participate in the study.
Who cannot join
- \1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy
- Conditions
- Post Partum Hemorrhage
- Being tested
- Misoprostol, Oxytocin
- 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
intrauterine tablets
OxytocinDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Experimental | intrauterine 400 microgram Receives: Drug: Misoprostol |
| oxytocin | Active comparator | intravenous infusion 10 units Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraoperative blood loss
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start2 Jul 2017
- Primary completion15 Sep 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148574
- Sponsor's protocol ID
- IUM
- Status last verified
- Apr 2021
- First submitted
- 9 May 2017
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03148574
- Acronym / sponsor ID
- IUM
- Conditions
- Post Partum Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 11 May 2017 (actual)
- 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.
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Experimental | Drug: Misoprostolintrauterine 400 microgram |
| oxytocin | Active comparator | Drug: Oxytocinintravenous infusion 10 units |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins.
- 3-Had no history of coagulopathy. 4-Accepting to participate in the study.
Key exclusion criteria (1 listed)
- \1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy
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 |
|---|---|---|
| Misoprostolintrauterine tablets | Drug | misoprostol |
| Oxytocinintravenous | Drug | oxytocin |
Primary outcome
amount of intraoperative blood loss
Time frame: 30 minutes
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 23 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Post Partum Hemorrhage
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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 Phase 3 study testing Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by Assiut University 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 2 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: finished, as of the sponsor's last update on 23 Apr 2021. 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.
What does this phase mean?
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?
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 intraoperative blood loss (time frame: 30 minutes). 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 23 Apr 2021.