Post Partum HemorrhagePhase 3NCT03463070
Misoprostol Before and After Cesarean Section
A Phase 3 study testing rectal misoprostol 600mg in people with Post Partum Hemorrhage, run by sarah mohamed hassan at 1 site in Egypt.
Trial summary
comparison of the effect of misoprostol before and after cesarean on the blood loss Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- rectal misoprostol 600mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2018to Sep 2018
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women not in active labor have reactive non-stress test.
- No contraindications to prostaglandins.
- Have no history of coagulopathy.
Who cannot join
- Placenta previa.
- Maternal hypertension.
- Diabetes mellitus.
- Previous CS and those with active labor.
- Multiple Fibroid uterus.
- Multiple pregnancies or polyhydramnios.
- Previous myomectomy, previous history of PPH.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Misoprostol Given Preoperative Versus Postoperative on Blood Loss With Elective Cesarean Section: Randomized Controlled Trial
comparison of the effect of misoprostol before and after cesarean on the blood loss
Read the detailed description
70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre
- Conditions
- Post Partum Hemorrhage
- Being tested
- rectal misoprostol 600mg
- Keywords
- misoprostol, postpartum haemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectal misoprostol 600mgDrug
70 women who received 600 mg misoprostol postoperatively at operating theatre
| Study group | Role | What they receive |
|---|---|---|
| preoperative misoprostol group | Active comparator | 70 women who received 600 mg misoprostol rectally preoperatively before cesarean section Receives: Drug: rectal misoprostol 600mg |
| postoperative misoprostol group | Active comparator | 70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section Receives: Drug: rectal misoprostol 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)
Measured: the operation time
postoperative blood loss
weighing the soaked napkins after collection of soaked towel
Measured: every 6 hours during first 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sarah mohamed hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463070
- Sponsor's protocol ID
- 1122345
- Status last verified
- Mar 2018
- First submitted
- 4 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- 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 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Misoprostol Given Preoperative Versus Postoperative on Blood Loss With Elective Cesarean Section: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03463070
- Acronym / sponsor ID
- 1122345
- Conditions
- Post Partum Hemorrhage
- Keywords
- misoprostol, postpartum haemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- sarah mohamed hassanUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 13 Mar 2018 (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.
comparison of the effect of misoprostol before and after cesarean on the blood loss
Detailed description
70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative misoprostol group | Active comparator | Drug: rectal misoprostol 600mg70 women who received 600 mg misoprostol rectally preoperatively before cesarean section |
| postoperative misoprostol group | Active comparator | Drug: rectal misoprostol 600mg70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women not in active labor have reactive non-stress test.
- No contraindications to prostaglandins.
- Have no history of coagulopathy.
Key exclusion criteria (7 listed)
- Placenta previa.
- Maternal hypertension.
- Diabetes mellitus.
- Previous CS and those with active labor.
- Multiple Fibroid uterus.
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 |
|---|---|---|
| rectal misoprostol 600mg70 women who received 600 mg misoprostol postoperatively at operating theatre | Drug | postoperative misoprostol group, preoperative misoprostol group |
Primary outcome
intraoperative blood loss
Time frame: the operation time
Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)
postoperative blood loss
Time frame: every 6 hours during first 24 hours.
weighing the soaked napkins after collection of soaked towel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Post Partum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
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 rectal misoprostol 600mg in people with Post Partum Hemorrhage, run by sarah mohamed hassan 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 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: status not confirmed, as of the sponsor's last update on 13 Mar 2018. 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?
Results are not available in the source record.
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?
intraoperative blood loss (time frame: the operation time). The study lists 2 primary outcomes in all. 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 13 Mar 2018.