Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery (QUOTABL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03233607
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rachana Gavara, Columbia University

Brief 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 quantitative blood loss (QBL).

Condition or disease Intervention/treatment
Hemorrhage, Postpartum Procedure: Blood Draw

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimal Time for Postpartum Hemoglobin Assessment and Its Correlation With Estimated Blood Loss (EBL)/Quantitative Blood Loss (QBL)
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : January 4, 2019
Actual Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: Blood Draw
On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.




Primary Outcome Measures :
  1. Change in maternal hemoglobin [ Time Frame: Day 1 and Day 2 ]
    Maternal hemoglobin will be measured on postpartum day 1 to day 2

  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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women who are admitted to the Allen hospital for delivery during the recruitment period.
Criteria

Inclusion Criteria:

All antepartum patients receiving prenatal care at the Broadway Practice and plan to deliver at Allen Hospital in NYC.

Exclusion Criteria:

Patients who gave consent to participate in the study but did not deliver at Allen hospital.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233607


Locations
Layout table for location information
United States, New York
Columbia University Irving Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Layout table for investigator information
Principal Investigator: Rachana Gavara, MD Columbia University

Layout table for additonal information
Responsible Party: Rachana Gavara, Assistant Professor of Obstetrics and Gynecology, Columbia University
ClinicalTrials.gov Identifier: NCT03233607     History of Changes
Other Study ID Numbers: AAAR4466
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans for sharing as this is a pilot study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rachana Gavara, Columbia University:
Postpartum
Hemoglobin

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage