Recombinant Factor VII for Intractable Postpartum Haemorrhage

March 18, 2022 updated by: Aljazeera Hospital

Recombinant Factor VII for the Conservative Management Trials of Intractable Postpartum Haemorrhage: is it a Drug Effect , Operator Experience or Inherent Result of the Aetiology.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major postpartum haemorrhage is a dangerous complication that accounts for the highest maternal morbidity rate

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Doaaa Alaa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women who has resistant postpartum hemorage

Description

Inclusion Criteria:

  • Women with severe resistant postpartum hemorage

Exclusion Criteria:

  • women without postpartum hemorage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Junior staff has started the management and called for the senior staff.
Drug: recombinant factor VIIa
using recombinant factor VIIa
senior staff. managed the case from the start
Drug: recombinant factor VIIa
using recombinant factor VIIa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of women who had hysterectomy
Time Frame: 24 hours
number of women resistant to the treatment and needed hysterectomy
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aljazeera Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Recombinant factor VII

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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