Hemorrhage, PostpartumQUOTABLNCT03233607
Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery
An observational study of Hemorrhage, Postpartum, run by Columbia University at 1 site in United States.
Trial summary
This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage, Postpartum
- What is being tested?
- Blood Draw
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 23 Apr 2019
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women who are admitted to the Allen hospital for delivery during the recruitment period.
Who may be able to join
- All antepartum patients receiving prenatal care at the Broadway Practice and plan to deliver at Allen Hospital in NYC.
Who cannot join
- Patients who gave consent to participate in the study but did not deliver at Allen hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Optimal Time for Postpartum Hemoglobin Assessment and Its Correlation With Estimated Blood Loss (EBL)/Quantitative Blood Loss (QBL)
This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and quantitative blood loss (QBL).
Read the detailed description
Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early intervention is dependent on care providers ability to accurately estimate ongoing blood loss. Studies in the past have shown that obstetricians and midwives tend to overestimate blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50 percent when a large volume of blood is lost.
Multiple studies have shown that routine hemoglobin assessment in postpartum patients after uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to increased cost of care without any added benefit and causes inconvenience to the patients. However knowing how imprecise blood loss estimation can be it is reasonable to screen women for anemia prior to discharge.
- Conditions
- Hemorrhage, Postpartum
- Being tested
- Blood Draw
- Keywords
- Postpartum, Hemoglobin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.
| Study group | Role | What they receive |
|---|---|---|
| Antepartum Patients | Includes antepartum patients receiving prenatal care at the Broadway Practice who plan to deliver at Allen Hospital in New York City (NYC). On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation. Receives: Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maternal hemoglobin
Maternal hemoglobin will be measured on postpartum day 1 to day 2
Measured: Day 1 and Day 2
Correlation of maternal hemoglobin to EBL
Maternal hemoglobin will be measured to assess correlation to visually estimated blood loss
Measured: Up to 2 days after delivery
Correlation of maternal hemoglobin to QBL
Maternal hemoglobin will be measured to assess correlation to quantified blood loss
Measured: Up to 2 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start20 Mar 2018
- Primary completion4 Jan 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage, PostpartumStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachana Gavara, Columbia University
- Investigators
- Rachana Gavara, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233607
- Sponsor's protocol ID
- AAAR4466
- Acronym
- QUOTABL
- Status last verified
- Apr 2019
- First submitted
- 26 Jul 2017
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for sharing as this is a pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Time for Postpartum Hemoglobin Assessment and Its Correlation With Estimated Blood Loss (EBL)/Quantitative Blood Loss (QBL)
- ClinicalTrials.gov ID
- NCT03233607
- Acronym / sponsor ID
- QUOTABL / AAAR4466
- Conditions
- Hemorrhage, Postpartum
- Keywords
- Postpartum, Hemoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 28 Jul 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.
This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and quantitative blood loss (QBL).
Detailed description
Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early intervention is dependent on care providers ability to accurately estimate ongoing blood loss. Studies in the past have shown that obstetricians and midwives tend to overestimate blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50 percent when a large volume of blood is lost.
Multiple studies have shown that routine hemoglobin assessment in postpartum patients after uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to increased cost of care without any added benefit and causes inconvenience to the patients. However knowing how imprecise blood loss estimation can be it is reasonable to screen women for anemia prior to discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antepartum Patients | – | Procedure: Blood DrawIncludes antepartum patients receiving prenatal care at the Broadway Practice who plan to deliver at Allen Hospital in New York City (NYC). On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who are admitted to the Allen hospital for delivery during the recruitment period.
Key inclusion criteria (1 listed)
- All antepartum patients receiving prenatal care at the Broadway Practice and plan to deliver at Allen Hospital in NYC.
Key exclusion criteria (1 listed)
- Patients who gave consent to participate in the study but did not deliver at Allen hospital.
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 |
|---|---|---|
| Blood DrawOn postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation. | Procedure or surgery | Antepartum Patients |
Primary outcome
Change in maternal hemoglobin
Time frame: Day 1 and Day 2
Maternal hemoglobin will be measured on postpartum day 1 to day 2
Correlation of maternal hemoglobin to EBL
Time frame: Up to 2 days after delivery
Maternal hemoglobin will be measured to assess correlation to visually estimated blood loss
Correlation of maternal hemoglobin to QBL
Time frame: Up to 2 days after delivery
Maternal hemoglobin will be measured to assess correlation to quantified blood loss
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 24 Apr 2019.
- Individual participant dataSharing planned: No. No plans for sharing as this is a pilot study.
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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.
Rachana Gavara, MD principal investigator
Columbia University
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 Hemorrhage, Postpartum, run by Columbia University at 1 site in United States.
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 24 Apr 2019. 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 United States. 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?
Change in maternal hemoglobin (time frame: Day 1 and Day 2). The study lists 3 primary outcomes in all. 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 24 Apr 2019.