Post Partum HemorrhageNCT05288322
Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery
A study testing Mostafa Maged maneuver in people with Post Partum Hemorrhage, run by Fayoum University at 1 site in Egypt.
Trial summary
PPH is commonly defined as blood loss exceeding 1000 milliliters after vaginal birth or cesarean section.1 PPH is often classified as primary/immediate/early (occurring within 24 hours of birth) or secondary/delayed/late (occurring from more than 24 hours postbirth to up to 12 weeks postpartum).. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Mostafa Maged maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant females Inclusion criteria :-
- All pregnant patients
- Age is between (18) to (40) years old
Who cannot join
- Smokers
- Morbid obese
- Medical history of blood diseases and collagen diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery
PPH is commonly defined as blood loss exceeding 1000 milliliters after vaginal birth or cesarean section.1 PPH is often classified as primary/immediate/early (occurring within 24 hours of birth) or secondary/delayed/late (occurring from more than 24 hours postbirth to up to 12 weeks postpartum)..
Atonic post-partum haemorrhage is one of the most challenging complications of normal delivery process . There are many maneuveurs applied to the atonic uterus for controlling the blood loss and conserving the uterus from hysterectomy process . There are pharmacological and surgical methods to control the bleeding . In this study , Mostafa Maged technique is to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method .
Read the detailed description
In this study , Mostafa Maged technique to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method . Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . Mostafa Maged technique is applied by :- (Description of the Mostafa Maged technique) :-
- First , placing the right hand to the posterior fornix of vaginal canal trying to cuddle the lower part of uterus compressing the anterior and posterior walls of the uterus .
- Second , placing the left hand over the fundus of the uterus and the posterior wall of uterus from the abdominal part of the pregnant mother ( the side of the abdominal skin ) .
- Third , by the two hands , trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is cuddling the symphysis pubis bone and in this way , getting the anterior and posterior walls of the uterus against each other compressed is achieved and reducing the intra-cavitary space so prevention of the expansion of the uterus is applied .
- Conditions
- Post Partum Hemorrhage
- Being tested
- Mostafa Maged maneuver
- Keywords
- Mostafa Maged maneuver, Atony, normal delivery, postpartum bleeding
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mostafa Maged maneuverProcedure or surgery
The Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . The Mostafa Maged technique is applied by :- (Description of the new Mostafa Maged technique) :-
- First , placing our right hand to the posterior fornix of vaginal canal trying to cuddle the lower part of uterus compressing the anterior and posterior walls of the uterus .
- Second , placing our left hand over the fundus of the uterus and the posterior wall of uterus from the abdominal part.
- Third , by our two hands , trying to grasp the whole uterus by our two hands abdominally and vaginally against the symphysis pubis as if the uterus is cuddling the symphysis pubis bone and in this way , we try to get the anterior and posterior walls against each other and reducing the intra-cavitary space so we prevent the expansion of the uterus .
| Study group | Role | What they receive |
|---|---|---|
| Mostafa Maged maneuver to prevent and control post-partum haemorrhage | Experimental | all pregnant females ( primigravida and multi-gravida ) . this study includes forty pregnant females with normal vaginal delivery .this study includes pregnant females Inclusion criteria :-
1. All pregnant patients
2. Age is between (18) to (40) years old
The Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . Receives: Procedure: Mostafa Maged maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-partum bleeding
prevention and treatment of post-partum bleeding in normal vaginal delivery by estimating the number of pads used during normal delivery to see amount of blood loss and to estimate the blood loss visually roughly as well
Measured: six hours post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start10 Apr 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 Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Fayoum 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT05288322
- Sponsor's protocol ID
- R218
- Status last verified
- Jul 2022
- First submitted
- 8 Mar 2022
- Last updated
- 29 Jul 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 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery
- ClinicalTrials.gov ID
- NCT05288322
- Acronym / sponsor ID
- R218
- Conditions
- Post Partum Hemorrhage
- Keywords
- Mostafa Maged maneuver, Atony, normal delivery, postpartum bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 21 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.
PPH is commonly defined as blood loss exceeding 1000 milliliters after vaginal birth or cesarean section.1 PPH is often classified as primary/immediate/early (occurring within 24 hours of birth) or secondary/delayed/late (occurring from more than 24 hours postbirth to up to 12 weeks postpartum)..
Atonic post-partum haemorrhage is one of the most challenging complications of normal delivery process . There are many maneuveurs applied to the atonic uterus for controlling the blood loss and conserving the uterus from hysterectomy process . There are pharmacological and surgical methods to control the bleeding . In this study , Mostafa Maged technique is to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method .
Detailed description
In this study , Mostafa Maged technique to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method . Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . Mostafa Maged technique is applied by :- (Description of the Mostafa Maged technique) :-
- First , placing the right hand to the posterior fornix of vaginal canal trying to cuddle the lower part of uterus compressing the anterior and posterior walls of the uterus .
- Second , placing the left hand over the fundus of the uterus and the posterior wall of uterus from the abdominal part of the pregnant mother ( the side of the abdominal skin ) .
- Third , by the two hands , trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is cuddling the symphysis pubis bone and in this way , getting the anterior and posterior walls of the uterus against each other compressed is achieved and reducing the intra-cavitary space so prevention of the expansion of the uterus is applied .
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mostafa Maged maneuver to prevent and control post-partum haemorrhage | Experimental | Procedure: Mostafa Maged maneuverall pregnant females ( primigravida and multi-gravida ) . this study includes forty pregnant females with normal vaginal delivery .this study includes pregnant females Inclusion criteria :- 1. All pregnant patients 2. Age is between (18) to (40) years old The Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant females Inclusion criteria :-
Key exclusion criteria (3 listed)
- Smokers
- Morbid obese
- Medical history of blood diseases and collagen diseases
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 maneuverThe Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . The Mostafa Maged technique is applied by :- (Description of the new Mostafa Maged technique) :- 1. First , placing our right hand to the posterior fornix of vaginal canal trying to cuddle the lower part of uterus compressing the anterior and posterior walls of the uterus . 2. Second , placing our left hand over the fundus of the uterus and the posterior wall of uterus from the abdominal part. 3. Third , by our two hands , trying to grasp the whole uterus by our two hands abdominally and vaginally against the symphysis pubis as if the uterus is cuddling the symphysis pubis bone and in this way , we try to get the anterior and posterior walls against each other and reducing the intra-cavitary space so we prevent the expansion of the uterus . | Procedure or surgery | Mostafa Maged maneuver to prevent and control post-partum haemorrhage |
Primary outcome
post-partum bleeding
Time frame: six hours post-delivery
prevention and treatment of post-partum bleeding in normal vaginal delivery by estimating the number of pads used during normal delivery to see amount of blood loss and to estimate the blood loss visually roughly as well
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 29 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Post Partum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
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
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 maneuver in people with Post Partum Hemorrhage, 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 3 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 29 Jul 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?
post-partum bleeding (time frame: six hours post-delivery). 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 29 Jul 2022.