Antepartum HemorrhageNCT02614053
Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage
An observational study of Antepartum Hemorrhage, run by Kasr El Aini Hospital.
Trial summary
The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Antepartum Hemorrhage
- What is being tested?
- Masimo Radical-7™ Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 2015
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: parturients with antepartum hemorrhage admitted for cesarean section
Who may be able to join
- Anesthesiologist (ASA) Physical status I - II.
- patients aged from 18 to 40 years
- full-term multigravida parturients
- antepartum hemorrhage
- singleton fetus
Who cannot join
- Patients with known cardiac problem
- peripheral circulatory failure of the upper extremities
- significant liver disease
- significant renal disease
- significant coagulopathy
About this study
Official title: Continuous Non Invasive Monitoring of Both Plethysmography Variability Index and Total Hemoglobin During Cesarean Section for Antepartum Hemorrhage As a Method For Early Detection of Bleeding
The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .
- Conditions
- Antepartum Hemorrhage
- Being tested
- Masimo Radical-7™ Pulse CO-Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Radical-7™ Pulse CO-OximeterDevice
a device collecting data regarding PVI, PI \& spHB
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleth Variability Index
Measured: 8 months
Secondary outcomes (1)
hemoglobin level
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antepartum 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed elsakka, Kasr El Aini Hospital
- Investigators
- nadia yo helmy, md, Study director, professor of anaesthesia cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614053
- Sponsor's protocol ID
- mp3
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Non Invasive Monitoring of Both Plethysmography Variability Index and Total Hemoglobin During Cesarean Section for Antepartum Hemorrhage As a Method For Early Detection of Bleeding
- ClinicalTrials.gov ID
- NCT02614053
- Acronym / sponsor ID
- mp3
- Conditions
- Antepartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 25 Nov 2015 (estimated)
- 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.
The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- parturients with antepartum hemorrhage admitted for cesarean section
Key inclusion criteria (5 listed)
- Anesthesiologist (ASA) Physical status I - II.
- patients aged from 18 to 40 years
- full-term multigravida parturients
- antepartum hemorrhage
- singleton fetus
Key exclusion criteria (5 listed)
- Patients with known cardiac problem
- peripheral circulatory failure of the upper extremities
- significant liver disease
- significant renal disease
- significant coagulopathy
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 |
|---|---|---|
| Masimo Radical-7™ Pulse CO-Oximetera device collecting data regarding PVI, PI \& spHB | Device | – |
Primary outcome
Pleth Variability Index
Time frame: 8 months
1 secondary outcome
hemoglobin level
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
Related trials for Antepartum Hemorrhage
Recruiting
Planned Delivery at 37 Versus 36 Weeks in Pregnancies With Placenta Previaand Accreta
Placenta Previa, Placenta Accreta Spectrum
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.
nadia yo helmy, md study director
professor of anaesthesia cairo university
Questions about this trial
What is this clinical trial studying?
An observational study of Antepartum Hemorrhage, run by Kasr El Aini Hospital.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pleth Variability Index (time frame: 8 months). 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 26 Nov 2015.