Postpartum HemorrhagePhase 2/3NCT02083107
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
A Phase 2/3 study testing Misoprostol in people with Postpartum Hemorrhage, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- 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
- 636 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2013to Feb 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients booked for elective cesarean section.
- Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section
Who cannot join
- Primigravida.
- Blood dyscrasias.
- Large fibroids.
- Multiple pregnancies.
- Overdistended uterus eg. Hydramnios.
- Pre-eclampsia.
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- Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl).
- Previous history of PPH.
- Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- Placenta previa.
- Contraindication to spinal anesthesia.
- Previous myomectomy.
- Previous two or more C.S.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS
The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol, Placebo
- Keywords
- Postpartum hemorrhage, Intrapartum blood loss, Misoprostol
- 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 Misotac, Cytotec
Comparison of different routes of administration of 400 micro gram misoprostol
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| sublingual misoprostol & rectal placebo | Experimental | will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". Receives: Drug: Misoprostol |
| rectal & sublingual placebo | Placebo comparator | will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". Receives: Other: Placebo |
| rectal misoprostol & sublingual placebo | Experimental | will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss
Measured: from start of cesarean section till the end of operation (average one hour)
Secondary outcomes (7)
Need for Extra Ecbolics (Oxytocin).
Measured: from start of cesarean section till the end of operation (average one hour)
APGAR Score
The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).
Measured: 1minute and 5 minutes from delivery of the fetus
Time to Resume Bowel Habits
Measured: average 24 hours
Need for Extra Analgesics
Measured: average 24 hours
Need for Postoperative Blood Transfusion
Measured: average 24 hours
Incidence of Wound Sepsis
Measured: upto one week
Incidence of Adverse Effects
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 posted11 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
- Investigators
- Mohamed S. Sweed, MD, Principal investigator, Ain Shams UniversityMourad M. El-Said, Professor, Study director, AinShams UniversityAmgad E. Abou-Gamrah, Ass.Prof., Study director, AinShams universityHaitham El-Sabe, MD, Study director, AinShams UniversityMohamed M. AbdEl-Hamid, Registrar, Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083107
- Sponsor's protocol ID
- 9021344
- Status last verified
- Nov 2015
- First submitted
- 7 Mar 2014
- Last updated
- 22 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS
- ClinicalTrials.gov ID
- NCT02083107
- Acronym / sponsor ID
- 9021344
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum hemorrhage, Intrapartum blood loss, Misoprostol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Posted 27 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sublingual misoprostol & rectal placebo | Experimental | Drug: Misoprostolwill receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". |
| rectal & sublingual placebo | Placebo comparator | Other: Placebowill receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". |
| rectal misoprostol & sublingual placebo | Experimental | Drug: Misoprostolwill receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients booked for elective cesarean section.
- Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section
Key exclusion criteria (13 listed)
- Primigravida.
- Blood dyscrasias.
- Large fibroids.
- Multiple pregnancies.
- Overdistended uterus eg. Hydramnios.
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: Misotac, CytotecComparison of different routes of administration of 400 micro gram misoprostol | Drug | rectal misoprostol & sublingual placebo, sublingual misoprostol & rectal placebo |
| Placebo | Other | rectal & sublingual placebo |
Primary outcome
Intraoperative Blood Loss
Time frame: from start of cesarean section till the end of operation (average one hour)
7 secondary outcomes
Need for Extra Ecbolics (Oxytocin).
Time frame: from start of cesarean section till the end of operation (average one hour)
APGAR Score
Time frame: 1minute and 5 minutes from delivery of the fetus
Time to Resume Bowel Habits
Time frame: average 24 hours
Need for Extra Analgesics
Time frame: average 24 hours
Need for Postoperative Blood Transfusion
Time frame: average 24 hours
Incidence of Wound Sepsis
Time frame: upto one week
Incidence of Adverse Effects
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postpartum Hemorrhage
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
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.
Mohamed S. Sweed, MD principal investigator
Ain Shams University
Mourad M. El-Said, Professor study director
AinShams University
Amgad E. Abou-Gamrah, Ass.Prof. study director
AinShams 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 Hemorrhage, 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 13 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 22 Dec 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: from start of cesarean section till the end of operation (average one hour)). 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 22 Dec 2015.