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OpenTrials
Completed

NCT Number: NCT03233607

Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery

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).

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood draw

Procedure

On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Acronym: QUOTABL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2017
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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