Placenta PreviaNCT05283122
Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases
A study testing Mostafa Maged Technique in people with Placenta Previa, run by Fayoum University at 1 site in Egypt.
Trial summary
Post - partum haemorrhage is still a headache to all obstetricians around the whole world . Every obstetrician exerts his own full effort to control bleeding which can occur post-partum by applying all maneuvers to preserve the fertility and the uterus for the patient . Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Mostafa Maged Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Mar 2022to 20 May 2022
- Phase
- Interventional
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant primigravida patients with placenta previa
- 18 to 30 years old
Who cannot join
- patients with bleeding disorders
- smokers
- morbid obese patients
Trial locations and contacts
1 site in 1 country.
About this study
Post - partum haemorrhage is still a headache to all obstetricians around the whole world . Every obstetrician exerts his own full effort to control bleeding which can occur post-partum by applying all maneuvers to preserve the fertility and the uterus for the patient .
demonstration of ( Mostafa Maged ) technique is applied to control and prevent post-partum haemorrhage . It is so simple maneuver and easy to be applied within short period of time .Satisfactory hemostasis can be assessed after application .
Read the detailed description
- pfannestiel incision .
- dissection of the bladder downwards , and then making an incision in the lower segment of the uterus , then the uterus is evacuated from the fetus and placenta .
- Ligation of the uterine arteries on both sides is applied before proceeding and after the extraction of fetus and placenta .
- The lower segment was bleeding so trying to do bimanual compression of the anterior and posterior parts of lower uterine segments to test if Mostafa Maged technique is useful in these cases or not (( by observing if the bleeding is minimized or stopped or not by compression )) as if it is minimized so our technique has a high chance to be effective .
- The whole technique depends on the anterior lower uterine segment by dividing the anterior lower uterine segment by an imaginary line in two halves , then , turning over (flipping ) the upper part of the lower uterine segment onto the lower part of the lower uterine segment from the inside of uterine cavity .
- doing this turnover (flipping ) by the hands and holding the imaginary line by two Allis forceps and by making three knots by three needles in the lower edge of the uterine incision and entering the needles of (absorbable 70 mm rounded-bodied vicryl 1 ) simultaneously into the lower segment through the uterine cavity , at the same level of , the inside wall of lower uterine segment in order to drag the upper (half) part of the lower uterine segment on the lower part of lower uterine segment ( sandwich - like ) , and after this maneuver the bleeding is re-evaluated again .
- Third , stitching the both sides of the flipped lower uterine segment by ( absorbable 70 mm rounded-bodied vicryl 1 ) , then doing plication of the anterior lower uterine segments to strengthen the wall of the flipped lower uterine segment and secure the tension .
- Fourth , closing the caeserian scar by suturing the already-flipped lower uterine segment onto the upper uterine segment .
- placing a drain in the doglus pouch
- Conditions
- Placenta Previa
- Being tested
- Mostafa Maged Technique
- Keywords
- Mostafa Maged technique, placenta previa, lower uterine segment, caeserian section
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mostafa Maged TechniqueProcedure or surgery
pfannestiel incision . dissection of the bladder downwards , and Ligation of the uterine arteries on both sides then , we turn over the upper part of the lower uterine segment onto the lower part of the lower uterine segment from the inside of uterine cavity .We do this turnover (flipping ) by our hands and holding the imaginary line by two Allis forceps and by making three knots by three needles in the lower edge of the uterine incision and we enter the needles of simultaneously into the lower segment through the uterine cavity , at the same level of , the inside wall of lower uterine segment to drag the upper (half) part of the lower uterine segment on the lower part of lower uterine segment ( sandwich - like ) Third , we stitch the both sides of the flipped lower uterine segment , then we do plication of the anterior lower uterine segments to strengthen the wall of the flipped lower uterine segment and place a drain in the doglus pouch
| Study group | Role | What they receive |
|---|---|---|
| The Mostafa Maged technique to prevent and control post-partum bleeding in placenta previa cases | Experimental | primigravida patients with placenta previa conditions and their ages between ( 18 - 30 ) years old Receives: Procedure: Mostafa Maged Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary post-partum bleeding
prevention and management of bleeding from lower segment ....estimation of number of pads used during section to estimate blood loss ... and to assess the number of blood loss postpartum roughly visually
Measured: twenty-four hours post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start24 Mar 2022
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- primigravida pregnant patients with placenta previa conditions
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Maged Ali, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283122
- Sponsor's protocol ID
- R 207
- Status last verified
- Jul 2022
- First submitted
- 8 Mar 2022
- Last updated
- 1 Aug 2022
- 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases
- ClinicalTrials.gov ID
- NCT05283122
- Acronym / sponsor ID
- R 207
- Conditions
- Placenta Previa
- Keywords
- Mostafa Maged technique, placenta previa, lower uterine segment, caeserian section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 16 Mar 2022 (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.
Post - partum haemorrhage is still a headache to all obstetricians around the whole world . Every obstetrician exerts his own full effort to control bleeding which can occur post-partum by applying all maneuvers to preserve the fertility and the uterus for the patient .
demonstration of ( Mostafa Maged ) technique is applied to control and prevent post-partum haemorrhage . It is so simple maneuver and easy to be applied within short period of time .Satisfactory hemostasis can be assessed after application .
Detailed description
- pfannestiel incision .
- dissection of the bladder downwards , and then making an incision in the lower segment of the uterus , then the uterus is evacuated from the fetus and placenta .
- Ligation of the uterine arteries on both sides is applied before proceeding and after the extraction of fetus and placenta .
- The lower segment was bleeding so trying to do bimanual compression of the anterior and posterior parts of lower uterine segments to test if Mostafa Maged technique is useful in these cases or not (( by observing if the bleeding is minimized or stopped or not by compression )) as if it is minimized so our technique has a high chance to be effective .
- The whole technique depends on the anterior lower uterine segment by dividing the anterior lower uterine segment by an imaginary line in two halves , then , turning over (flipping ) the upper part of the lower uterine segment onto the lower part of the lower uterine segment from the inside of uterine cavity .
- doing this turnover (flipping ) by the hands and holding the imaginary line by two Allis forceps and by making three knots by three needles in the lower edge of the uterine incision and entering the needles of (absorbable 70 mm rounded-bodied vicryl 1 ) simultaneously into the lower segment through the uterine cavity , at the same level of , the inside wall of lower uterine segment in order to drag the upper (half) part of the lower uterine segment on the lower part of lower uterine segment ( sandwich - like ) , and after this maneuver the bleeding is re-evaluated again .
- Third , stitching the both sides of the flipped lower uterine segment by ( absorbable 70 mm rounded-bodied vicryl 1 ) , then doing plication of the anterior lower uterine segments to strengthen the wall of the flipped lower uterine segment and secure the tension .
- Fourth , closing the caeserian scar by suturing the already-flipped lower uterine segment onto the upper uterine segment .
- placing a drain in the doglus pouch
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- primigravida pregnant patients with placenta previa conditions
| Arm | Type | Receives |
|---|---|---|
| The Mostafa Maged technique to prevent and control post-partum bleeding in placenta previa cases | Experimental | Procedure: Mostafa Maged Techniqueprimigravida patients with placenta previa conditions and their ages between ( 18 - 30 ) years old |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant primigravida patients with placenta previa
- 18 to 30 years old
Key exclusion criteria (3 listed)
- patients with bleeding disorders
- smokers
- morbid obese patients
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 |
|---|---|---|
| Mostafa Maged Techniquepfannestiel incision . dissection of the bladder downwards , and Ligation of the uterine arteries on both sides then , we turn over the upper part of the lower uterine segment onto the lower part of the lower uterine segment from the inside of uterine cavity .We do this turnover (flipping ) by our hands and holding the imaginary line by two Allis forceps and by making three knots by three needles in the lower edge of the uterine incision and we enter the needles of simultaneously into the lower segment through the uterine cavity , at the same level of , the inside wall of lower uterine segment to drag the upper (half) part of the lower uterine segment on the lower part of lower uterine segment ( sandwich - like ) Third , we stitch the both sides of the flipped lower uterine segment , then we do plication of the anterior lower uterine segments to strengthen the wall of the flipped lower uterine segment and place a drain in the doglus pouch | Procedure or surgery | The Mostafa Maged technique to prevent and control post-partum bleeding in placenta previa cases |
Primary outcome
primary post-partum bleeding
Time frame: twenty-four hours post-partum
prevention and management of bleeding from lower segment ....estimation of number of pads used during section to estimate blood loss ... and to assess the number of blood loss postpartum roughly visually
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 1 Aug 2022.
- Individual participant dataSharing planned: No
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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.
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 study testing Mostafa Maged Technique in people with Placenta Previa, run by Fayoum 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 3 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 1 Aug 2022. 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.
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?
primary post-partum bleeding (time frame: twenty-four hours post-partum). 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 1 Aug 2022.