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

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).

Study Overview

• Status: Completed
• Conditions: Hemorrhage, Postpartum
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who are admitted to the Allen hospital for delivery during the recruitment period.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal hemoglobin	Maternal hemoglobin will be measured on postpartum day 1 to day 2	Day 1 and Day 2
Correlation of maternal hemoglobin to EBL	Maternal hemoglobin will be measured to assess correlation to visually estimated blood loss	Up to 2 days after delivery
Correlation of maternal hemoglobin to QBL	Maternal hemoglobin will be measured to assess correlation to quantified blood loss	Up to 2 days after delivery

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Rachana Gavara, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Postpartum; Hemoglobin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: AAAR4466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans for sharing as this is a pilot study.

Drug and device information, study documents

• 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