Back to resultsMostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage
Primary Purpose
Post-partum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mostafa Maged maneuver
Bimanual uterine compression
Sponsored by
About this trial
This is an interventional treatment trial for Post-partum Hemorrhage focused on measuring Mostafa Maged maneuver, Bimanual uterine compression, vaginal delivery, postpartum hemorrhage
Eligibility Criteria
Inclusion Criteria: - female and pregnant Exclusion Criteria: hematological diseases morbid obese smoking
Sites / Locations
- Fayoum general hospital and al azhar university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Group 1 : Mostafa Maged maneuver
Group 2 : bimanual uterine compression
Arm Description
The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)
Both maneuver s are performed immediately after the delivery of the placenta and foetus, with no uterotonics administered at the onset of these maneuver s. In the event of atony after hand release due to fatigue, 5 IU of oxytocin is administered intravenously as uterotonics. the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.
Outcomes
Primary Outcome Measures
Good hemostasis and achieving the uterus contracted
no post-partum hemorrhage , we assess this by the amount of bleeding going down and by the atonic status of the uterus at that time
obstetrician does not feel fatigued
no exhaustion for the obstetrician , and this outcome is told by the investigators themselves
Secondary Outcome Measures
Full Information
NCT ID
NCT06002256
First Posted
August 6, 2023
Last Updated
September 11, 2023
Sponsor
Ministry of Health and Population, Egypt
Collaborators
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT06002256
Brief Title
Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage
Official Title
Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health and Population, Egypt
Collaborators
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal delivery.
The study subjects were categorized into two groups. The first group was managed by the Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine compression.
investigators attempted to determine the duration of each maneuver required until the investigator became exhausted, as well as whether or not oxytocin was administered later in each maneuver .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-partum Hemorrhage
Keywords
Mostafa Maged maneuver, Bimanual uterine compression, vaginal delivery, postpartum hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 : Mostafa Maged maneuver
Arm Type
Active Comparator
Arm Description
The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)
Arm Title
Group 2 : bimanual uterine compression
Arm Type
Other
Arm Description
Both maneuver s are performed immediately after the delivery of the placenta and foetus, with no uterotonics administered at the onset of these maneuver s. In the event of atony after hand release due to fatigue, 5 IU of oxytocin is administered intravenously as uterotonics.
the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.
Intervention Type
Procedure
Intervention Name(s)
Mostafa Maged maneuver
Intervention Description
While the patient is on the lithotomy position , The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved)
Intervention Type
Procedure
Intervention Name(s)
Bimanual uterine compression
Intervention Description
the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.
Primary Outcome Measure Information:
Title
Good hemostasis and achieving the uterus contracted
Description
no post-partum hemorrhage , we assess this by the amount of bleeding going down and by the atonic status of the uterus at that time
Time Frame
first 3 hours
Title
obstetrician does not feel fatigued
Description
no exhaustion for the obstetrician , and this outcome is told by the investigators themselves
Time Frame
during applying the maneuver
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female pregnant
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- female and pregnant
Exclusion Criteria:
hematological diseases morbid obese smoking
Facility Information:
Facility Name
Fayoum general hospital and al azhar university
City
Cairo
State/Province
Cairo And Fayoum
ZIP/Postal Code
0020
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage
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