NCT05288322

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

April 10, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

March 8, 2022

Last Update Submit

July 27, 2022

Conditions

Keywords

Mostafa Maged maneuverAtonynormal deliverypostpartum bleeding

Outcome Measures

Primary Outcomes (1)

  • 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

    six hours post-delivery

Study Arms (1)

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 .

Procedure: Mostafa Maged maneuver

Interventions

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) :- 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 .

Mostafa Maged maneuver to prevent and control post-partum haemorrhage

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All pregnant patients
  • Age is between (18) to (40) years old

You may not qualify if:

  • Smokers
  • Morbid obese
  • Medical history of blood diseases and collagen diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum general hospital and Fayoum university

Al Fayyum, 0020, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 21, 2022

Study Start

April 10, 2022

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations