NCT04812821

Brief Summary

Anemia is a common pregnancy condition that has multiple origins. Its frequency and severity seem to be increasing, despite the existing management recommendations and the awareness of health professionals. The objective of this study is to make a statement of this pathology within our establishment, to evaluate the proportion of patients presenting this pathology and to highlight possible risk factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,177

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 16, 2021

Last Update Submit

March 15, 2022

Conditions

Pregnancy Anemia

Outcome Measures

Primary Outcomes (1)

  • Estimation of the proportion of patients presenting anemia during delivery

    Percentage of patients with hemoglobin less than 10.5 g/dl at entry into the delivery room

    6 month

Secondary Outcomes (1)

  • Risk factors underlying anemia during delivery with a large questionnaire

    6 month

Interventions

questionnaireOTHER

questionnaire post delivery

Eligibility Criteria

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

All patients presenting eligibility criteria and giving birth at NFC Hospital

You may qualify if:

  • \> 18 years
  • Delivery at Nord Franche-Comte Hospital
  • Delivery ≥ 32 weeks of amenorrhea
  • Informed patient and non-opposition of participation

You may not qualify if:

  • Protected adults (Patients under guardianship, curatorship, safeguard of justice or under family authorization)
  • Medical interruption of pregnancy
  • Patients with fetal death in utero or neonatal death
  • Minor patients
  • Premature delivery before 32 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Nord Franche-Comté

Trévenans, 90400, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 24, 2021

Study Start

April 12, 2021

Primary Completion

October 12, 2021

Study Completion

March 15, 2022

Last Updated

March 16, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)