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Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mostafa Maged maneuver
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage focused on measuring Mostafa Maged maneuver, Atony, normal delivery, postpartum bleeding

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnant females Inclusion criteria :-

    1. All pregnant patients
    2. Age is between (18) to (40) years old

Exclusion Criteria:

  1. Smokers
  2. Morbid obese
  3. Medical history of blood diseases and collagen diseases

Sites / Locations

  • Fayoum general hospital and Fayoum university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mostafa Maged maneuver to prevent and control post-partum haemorrhage

Arm Description

all pregnant females ( primigravida and multi-gravida ) . this study includes forty pregnant females with normal vaginal delivery .this study includes pregnant females Inclusion criteria :- All pregnant patients 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 .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 8, 2022
Last Updated
July 27, 2022
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05288322
Brief Title
Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery
Official Title
The Effectiveness of Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum 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
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 .

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, Atony, normal delivery, postpartum bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mostafa Maged maneuver to prevent and control post-partum haemorrhage
Arm Type
Experimental
Arm Description
all pregnant females ( primigravida and multi-gravida ) . this study includes forty pregnant females with normal vaginal delivery .this study includes pregnant females Inclusion criteria :- All pregnant patients 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 .
Intervention Type
Procedure
Intervention Name(s)
Mostafa Maged maneuver
Intervention Description
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 .
Primary Outcome Measure Information:
Title
post-partum bleeding
Description
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
Time Frame
six hours post-delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnant females Inclusion criteria :- All pregnant patients Age is between (18) to (40) years old Exclusion Criteria: Smokers Morbid obese Medical history of blood diseases and collagen diseases
Facility Information:
Facility Name
Fayoum general hospital and Fayoum university
City
Fayoum
ZIP/Postal Code
0020
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery

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