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Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases

Primary Purpose

Placenta Previa

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

About this trial

This is an interventional prevention trial for Placenta Previa focused on measuring Mostafa Maged technique, placenta previa, lower uterine segment, caeserian section

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • pregnant primigravida patients with placenta previa
  • 18 to 30 years old

Exclusion Criteria:

  • patients with bleeding disorders
  • smokers
  • morbid obese patients

Sites / Locations

  • Fayoum general hospital and Fayoum university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Mostafa Maged technique to prevent and control post-partum bleeding in placenta previa cases

Arm Description

primigravida patients with placenta previa conditions and their ages between ( 18 - 30 ) years old

Outcomes

Primary Outcome Measures

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

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
NCT05283122
Brief Title
Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases
Official Title
Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 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
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 . 5) 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 . 6) 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 . 7) 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 . 8) 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 . 9) Fourth , closing the caeserian scar by suturing the already-flipped lower uterine segment onto the upper uterine segment . 10) placing a drain in the doglus pouch

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
Keywords
Mostafa Maged technique, placenta previa, lower uterine segment, caeserian section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
primigravida pregnant patients with placenta previa conditions
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Mostafa Maged technique to prevent and control post-partum bleeding in placenta previa cases
Arm Type
Experimental
Arm Description
primigravida patients with placenta previa conditions and their ages between ( 18 - 30 ) years old
Intervention Type
Procedure
Intervention Name(s)
Mostafa Maged Technique
Intervention Description
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
Primary Outcome Measure Information:
Title
primary post-partum bleeding
Description
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
Time Frame
twenty-four hours post-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pregnant primigravida patients with placenta previa 18 to 30 years old Exclusion Criteria: patients with bleeding disorders smokers morbid obese patients
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

Learn more about this trial

Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases

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