Post Partum HemorrhagePhase 4NCT03680339
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
A Phase 4 study testing cesarean section, Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally… 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?
- cesarean section, Misoprostol and Oxytocin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2018to 28 Jan 2019
- Phase
- Phase 4
- 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 attending for elective CS.
- Age between 20-35 years.
- Normal placental site
- Normal coagulation profile
- Full term pregnancies(above 37 wks)
- Medically free
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- Spinal anesthesia
- Living baby
- Average liquor by U/S
Who cannot join
- • Women attending for emergency CS
- .age below 20 or above 35
- Abnormal placentation (Placenta previa,accrete,increta or percreta)
- Women with coagulopathy
- Preterm pregnancies (before 37 wks)
- Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
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- General anathesia
- IUFD
- Oligo or polyhydraminos by U/S
Trial locations and contacts
1 site in 1 country.
About this study
- Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Then we will compare between two groups regarding
- Intaoperative blood loss
- Risk of Postpartum hemorraghe in the first 24 hrs
- HB pre and postoperative for all patients
Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit
Read the detailed description
- Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Then we will compare between two groups regarding
- Intaoperative blood loss
- Risk of Postpartum hemorraghe in the first 24 hrs
- HB pre and postoperative for all patients
Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit
- Conditions
- Post Partum Hemorrhage
- Being tested
- cesarean section, 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.
cesarean sectionProcedure or surgery
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers
MisoprostolDrug
Also called Cytotec
The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
OxytocinDrug
10 IU of oxytocin with fetal delivery
| Study group | Role | What they receive |
|---|---|---|
| Routine ecbolic group | Active comparator | 100 patients will receive routine ecbolics ( oxytocin) after delivery of baby Receives: Procedure: cesarean section; Drug: Oxytocin |
| Misoprostol group | Active comparator | The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen Receives: Procedure: cesarean section; Drug: Misoprostol; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum hemorrhage
Measured: 24 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start2 Sep 2018
- Primary completion1 Jan 2019
- Study completion28 Jan 2019
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.
- More trials run by Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680339
- Sponsor's protocol ID
- 42
- Status last verified
- Jun 2023
- First submitted
- 19 Sep 2018
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maged AM, Fawzi T, Shalaby MA, Samy A, Rabee MA, Ali AS, Hussein EA, Hammad B, Deeb WS. A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery. Int J Gynaecol Obstet. 2019 Oct;147(1):102-107. doi: 10.1002/ijgo.12922. Epub 2019 Jul 25.
PubMed 31304593
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
- ClinicalTrials.gov ID
- NCT03680339
- Acronym / sponsor ID
- 42
- Conditions
- Post Partum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 21 Sep 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.
- Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Then we will compare between two groups regarding
- Intaoperative blood loss
- Risk of Postpartum hemorraghe in the first 24 hrs
- HB pre and postoperative for all patients
Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit
Detailed description
- Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Then we will compare between two groups regarding
- Intaoperative blood loss
- Risk of Postpartum hemorraghe in the first 24 hrs
- HB pre and postoperative for all patients
Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine ecbolic group | Active comparator | Procedure: cesarean section, Drug: Oxytocin100 patients will receive routine ecbolics ( oxytocin) after delivery of baby |
| Misoprostol group | Active comparator | Procedure: cesarean section, Drug: Misoprostol, Drug: OxytocinThe 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- women attending for elective CS.
- Age between 20-35 years.
- Normal placental site
- Normal coagulation profile
- Full term pregnancies(above 37 wks)
Key exclusion criteria (9 listed)
- • Women attending for emergency CS
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 |
|---|---|---|
| cesarean sectionCS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers | Procedure or surgery | Misoprostol group, Routine ecbolic group |
| MisoprostolAlso: CytotecThe 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen | Drug | Misoprostol group |
| Oxytocin10 IU of oxytocin with fetal delivery | Drug | Misoprostol group, Routine ecbolic group |
Primary outcome
postpartum hemorrhage
Time frame: 24 hours after cesarean section
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 27 Jun 2023.
- Derived from this study: PubMed 31304593Maged AM, Fawzi T, Shalaby MA, Samy A, Rabee MA, Ali AS, Hussein EA, Hammad B, Deeb WS. A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery. Int J Gynaecol Obstet. 2019 Oct;147(1):102-107. doi: 10.1002/ijgo.12922. Epub 2019 Jul 25.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed maged, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cesarean section, Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by Cairo 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 9 inclusion and 9 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 27 Jun 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
postpartum hemorrhage (time frame: 24 hours after cesarean section). 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 NCT03680339, 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 27 Jun 2023.