Postpartum HemorrhageNCT03135158
The Association Between Shock Index and Severity of Postpartum Blood Loss
An observational study of Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Colombia.
Trial summary
The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Exposure to vaginal delivery
- How many people
- 298 participants
- Where
- 1 siteColombia
- Study dates
- 18 Apr 2017to 5 Dec 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women presenting for vaginal delivery will be invited to participate
Who may be able to join
- Receive care for vaginal delivery
Who cannot join
- Scheduled or transferred for cesarean section
- Cannot give informed consent
- Are not willing and/or cannot answer the questionnaire on their background
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study
The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Exposure to vaginal delivery
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to vaginal deliveryOther
Women who have vaginal births are observed for a minimum of 1 hour postpartum
| Study group | Role | What they receive |
|---|---|---|
| Women in labor | All participants who have a vaginal delivery Receives: Other: Exposure to vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between blood loss and shock index
Correlate shock index, heart rate, and blood pressure measurements with blood loss levels at 15, 30, 45 \& 60 minutes
Measured: Within 1 hour postpartum
Secondary outcomes (5)
Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml
Proportions with ≥ 500 ml and ≥ 1000 ml blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops
Measured: Up to two hours postpartum
Median blood loss in the postpartum and interquartile range
Blood loss at 30 and 60 minutes postpartum, at PPH diagnosis (if applicable), and when active bleeding stops
Measured: Up to two hours postpartum
Percentage of women who received treatment to control bleeding
Measured: Up to two hours postpartum
Average change in Hb measured before and after delivery
Among women receiving treatment to control postpartum hemorrhage
Measured: Pre-delivery and at least 24 hours postpartum
Percentage of women with complications
Among women receiving treatment to control postpartum hemorrhage
Measured: Through study completion, an average of 24-48 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start18 Apr 2017
- Primary completion30 Nov 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum 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
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinica Valle del Lili
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsJill Durocher, Principal investigator, Gynuity Health ProjectsIlana Dzuba, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135158
- Sponsor's protocol ID
- 3009
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2017
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study
- ClinicalTrials.gov ID
- NCT03135158
- Acronym / sponsor ID
- 3009
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Fundacion Clinica Valle del Lili
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 1 May 2017 (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.
The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women in labor | – | Other: Exposure to vaginal deliveryAll participants who have a vaginal delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women presenting for vaginal delivery will be invited to participate
Key inclusion criteria (1 listed)
- Receive care for vaginal delivery
Key exclusion criteria (3 listed)
- Scheduled or transferred for cesarean section
- Cannot give informed consent
- Are not willing and/or cannot answer the questionnaire on their background
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 |
|---|---|---|
| Exposure to vaginal deliveryWomen who have vaginal births are observed for a minimum of 1 hour postpartum | Other | Women in labor |
Primary outcome
Correlation between blood loss and shock index
Time frame: Within 1 hour postpartum
Correlate shock index, heart rate, and blood pressure measurements with blood loss levels at 15, 30, 45 \& 60 minutes
5 secondary outcomes
Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml
Time frame: Up to two hours postpartum
Median blood loss in the postpartum and interquartile range
Time frame: Up to two hours postpartum
Percentage of women who received treatment to control bleeding
Time frame: Up to two hours postpartum
Average change in Hb measured before and after delivery
Time frame: Pre-delivery and at least 24 hours postpartum
Percentage of women with complications
Time frame: Through study completion, an average of 24-48 hours postpartum
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 30 Apr 2018.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Jill Durocher principal investigator
Gynuity Health Projects
Ilana Dzuba, MPH principal investigator
Gynuity Health Projects
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 Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Colombia.
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 3 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 30 Apr 2018. 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 Colombia. 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?
Correlation between blood loss and shock index (time frame: Within 1 hour postpartum). 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 30 Apr 2018.