NCT06002256

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

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

Study Start

First participant enrolled

July 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

August 6, 2023

Last Update Submit

July 19, 2024

Conditions

Keywords

Mostafa Maged maneuverBimanual uterine compressionvaginal deliverypostpartum hemorrhage

Outcome Measures

Primary Outcomes (2)

  • 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

    first 3 hours

  • obstetrician does not feel fatigued

    no exhaustion for the obstetrician , and this outcome is told by the investigators themselves

    during applying the maneuver

Study Arms (2)

Group 1 : Mostafa Maged maneuver

ACTIVE COMPARATOR

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

Group 2 : bimanual uterine compression

OTHER

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

Interventions

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)

Group 1 : Mostafa Maged maneuver

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

Group 2 : bimanual uterine compression

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale pregnant
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- female and pregnant

You may not qualify if:

  • hematological diseases morbid obese smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum general hospital and al azhar university

Cairo, Cairo and Fayoum, 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 21, 2023

Study Start

July 5, 2023

Primary Completion

October 20, 2023

Study Completion

October 25, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations