Post Partum HemorrhageNCT05298826
Recombinant Factor VII for Intractable Postpartum Haemorrhage
An observational study of Post Partum Hemorrhage, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- recombinant factor VIIa
- How many people
- 41 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women who has resistant postpartum hemorage
Who may be able to join
- Women with severe resistant postpartum hemorage
Who cannot join
- women without postpartum hemorage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the detailed description
Major postpartum haemorrhage is a dangerous complication that accounts for the highest maternal morbidity rate
- Conditions
- Post Partum Hemorrhage
- Being tested
- recombinant factor VIIa
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant factor VIIaDrug
using recombinant factor VIIa
| Study group | Role | What they receive |
|---|---|---|
| Junior staff has started the management and called for the senior staff. | Not described Receives: Drug: recombinant factor VIIa | |
| senior staff. managed the case from the start | Not described Receives: Drug: recombinant factor VIIa |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who had hysterectomy
number of women resistant to the treatment and needed hysterectomy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jun 2019
- Primary completion1 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298826
- Sponsor's protocol ID
- Recombinant factor VII
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05298826
- Acronym / sponsor ID
- Recombinant factor VII
- Conditions
- Post Partum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum haemorrhage remains at the top of the causes of maternal deaths in both developed and developing countries .
Detailed description
Major postpartum haemorrhage is a dangerous complication that accounts for the highest maternal morbidity rate
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women who has resistant postpartum hemorage
Key inclusion criteria (1 listed)
- Women with severe resistant postpartum hemorage
Key exclusion criteria (1 listed)
- women without postpartum hemorage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant factor VIIausing recombinant factor VIIa | Drug | Junior staff has started the management and called for the senior staff., senior staff. managed the case from the start |
Primary outcome
The number of women who had hysterectomy
Time frame: 24 hours
number of women resistant to the treatment and needed hysterectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Hemorrhage, run by Aljazeera Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who had hysterectomy (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.