Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery

Hemorrhage, Postpartum Clinical Trial

— QUOTABL  

Official title:

Optimal Time for Postpartum Hemoglobin Assessment and Its Correlation With Estimated Blood Loss (EBL)/Quantitative Blood Loss (QBL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233607
• Other study ID #: AAAR4466
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: April 23, 2019

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 quantitative blood loss (QBL).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 23, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage, Postpartum
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maternal hemoglobin	Maternal hemoglobin will be measured on postpartum day 1 to day 2	Day 1 and Day 2
Primary	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
Primary	Correlation of maternal hemoglobin to QBL	Maternal hemoglobin will be measured to assess correlation to quantified blood loss	Up to 2 days after delivery