NCT03233607

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

July 26, 2017

Last Update Submit

April 23, 2019

Conditions

Keywords

PostpartumHemoglobin

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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

Interventions

Blood DrawPROCEDURE

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

Antepartum Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Rachana Gavara, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

March 20, 2018

Primary Completion

January 4, 2019

Study Completion

April 23, 2019

Last Updated

April 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

No plans for sharing as this is a pilot study.

Locations