Postpartum HaemorrhagePhase 2/3NCT02509351
Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?
A Phase 2/3 study testing misoprostol in people with Postpartum Haemorrhage, run by Ain Shams University at 1 site in Egypt.
Trial summary
Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby. The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Haemorrhage
- What is being tested?
- misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Nov 2016
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 38-41 weeks of amenorrhea
- scheduled for elective lower segment cesarean section
Who cannot join
- confirmed intrauterine fetal death
- more than previous 2 ceserean sections
- multiple pregnancy
- antepartum haemorrhage
- self-reported maternal heart disease
- current diagnosis of severe malaria or acute bacterial infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section
- Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
- The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin
Read the detailed description
Research question:
In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?
Research hypothesis:
pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section
- Conditions
- Postpartum Haemorrhage
- Being tested
- misoprostol, placeboo
- 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 mesotac
400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section
placebooDrug
Also called control
women will recive 2 identical tablets as placeboo
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Experimental | women receiving pre-operative rectally administered 400 microgram misoprostol Receives: Drug: misoprostol |
| placeboo | Active comparator | women receiving placebo Receives: Drug: placeboo |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of intraoperative blood loss
volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor
Measured: 30 minute
Secondary outcomes (7)
maternal mortality
Measured: 6 months
mean measured blood loss
Measured: 1, 2, and 24 h postpartum
placental retention
when the placenta is not delivered spontaneously for 30 minutes
Measured: 30 minutes
requirement for blood transfusion
indicated per clinical protocol at the study site for mothers with a hemoglobin <100 g/l and/or severe pallor
Measured: 24 hours
requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures
Measured: 24 hours
postpartum hemoglobin
less than 10gm%
Measured: 24 hours
mean postpartum hematocrit
more than 10% drop in the postpartum hematocrit
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 posted28 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HaemorrhageStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
- Investigators
- Helmy Dr metawe, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509351
- Sponsor's protocol ID
- POMCS
- Status last verified
- May 2016
- First submitted
- 24 Jul 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Double Blind Study of Preoperative Misorostol for Reduction of Intraoperative Bleeding in Women Delivered by Ceserean Section
- ClinicalTrials.gov ID
- NCT02509351
- Acronym / sponsor ID
- POMCS
- Conditions
- Postpartum Haemorrhage
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jul 2015 (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.
- Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
- The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin
Detailed description
Research question:
In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?
Research hypothesis:
pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Experimental | Drug: misoprostolwomen receiving pre-operative rectally administered 400 microgram misoprostol |
| placeboo | Active comparator | Drug: placeboowomen receiving placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 38-41 weeks of amenorrhea
- scheduled for elective lower segment cesarean section
Key exclusion criteria (6 listed)
- confirmed intrauterine fetal death
- more than previous 2 ceserean sections
- multiple pregnancy
- antepartum haemorrhage
- self-reported maternal heart disease
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: mesotac400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section | Drug | misoprostol |
| placebooAlso: controlwomen will recive 2 identical tablets as placeboo | Drug | placeboo |
Primary outcome
volume of intraoperative blood loss
Time frame: 30 minute
volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor
7 secondary outcomes
maternal mortality
Time frame: 6 months
mean measured blood loss
Time frame: 1, 2, and 24 h postpartum
placental retention
Time frame: 30 minutes
requirement for blood transfusion
Time frame: 24 hours
requirement for additional management of PPH, including therapeutic uterotonic drugs or surgical or radiological procedures
Time frame: 24 hours
postpartum hemoglobin
Time frame: 24 hours
mean postpartum hematocrit
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 10 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Postpartum Haemorrhage
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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
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
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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.
Helmy Dr metawe, MD study chair
Ain Shams University
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 Postpartum Haemorrhage, run by Ain Shams 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 6 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 10 Nov 2016. 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 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?
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?
volume of intraoperative blood loss (time frame: 30 minute). 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 10 Nov 2016.