Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage

Sponsor

Ministry of Health and Population, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT06002256

Collaborator

Al-Azhar University (Other)

Enrollment

Location

Arms

3.3

Actual Duration (Months)

15.2

Patients Per Site Per Month

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Post-partum Hemorrhage	Procedure: Mostafa Maged maneuver Procedure: Bimanual uterine compression	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage

Actual Study Start Date :

Apr 22, 2023

Actual Primary Completion Date :

Jul 30, 2023

Actual Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 : Mostafa Maged maneuver 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)	Procedure: Mostafa Maged maneuver 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)
Other: Group 2 : bimanual uterine compression 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.	Procedure: Bimanual uterine compression the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.

Arm

Intervention/Treatment

Active Comparator: Group 1 : Mostafa Maged maneuver

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)

Procedure: Mostafa Maged maneuver

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)

Other: Group 2 : bimanual uterine compression

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.

Procedure: Bimanual uterine compression

the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.

Outcome Measures

Primary Outcome Measures

Good hemostasis and achieving the uterus contracted [first 3 hours]
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 [during applying the maneuver]
no exhaustion for the obstetrician , and this outcome is told by the investigators themselves

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

female and pregnant

Exclusion Criteria:

hematological diseases morbid obese smoking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fayoum general hospital and al azhar university	Cairo	Cairo And Fayoum	Egypt	0020

Sponsors and Collaborators

Ministry of Health and Population, Egypt
Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Maged Ali, principal investigator, Ministry of Health and Population, Egypt

ClinicalTrials.gov Identifier:

NCT06002256

Other Study ID Numbers:

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mostafa Maged Ali, principal investigator, Ministry of Health and Population, Egypt

Mostafa Maged maneuver

Bimanual uterine compression

vaginal delivery

postpartum hemorrhage

Additional relevant MeSH terms:

Postpartum Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Aug 21, 2023