NCT05298826

Brief Summary

Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

March 18, 2022

Last Update Submit

March 18, 2022

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • The number of women who had hysterectomy

    number of women resistant to the treatment and needed hysterectomy

    24 hours

Study Arms (2)

Junior staff has started the management and called for the senior staff.

Drug: recombinant factor VIIa

senior staff. managed the case from the start

Drug: recombinant factor VIIa

Interventions

recombinant factor VIIaDRUG

using recombinant factor VIIa

Junior staff has started the management and called for the senior staff.senior staff. managed the case from the start

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with resistant postpartum hemorage
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women who has resistant postpartum hemorage

You may qualify if:

  • Women with severe resistant postpartum hemorage

You may not qualify if:

  • women without postpartum hemorage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaaa Alaa

Cairo, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 28, 2022

Study Start

June 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 10, 2020

Last Updated

March 28, 2022

Record last verified: 2022-03

Locations

EG(1)