- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812821
Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital (ANEMIA)
March 15, 2022 updated by: Hopital Nord Franche-Comte
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
1177
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trévenans, France, 90400
- Hôpital Nord Franche-Comté
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All patients presenting eligibility criteria and giving birth at NFC Hospital
Description
Inclusion Criteria:
- > 18 years
- Delivery at Nord Franche-Comte Hospital
- Delivery ≥ 32 weeks of amenorrhea
- Informed patient and non-opposition of participation
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimation of the proportion of patients presenting anemia during delivery
Time Frame: 6 month
|
Percentage of patients with hemoglobin less than 10.5 g/dl at entry into the delivery room
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors underlying anemia during delivery with a large questionnaire
Time Frame: 6 month
|
Link between presence or absence of anemia and type of follow-up (gynecological or midwife, anemia during pregnancy and iron supplementation strategy and compliance), living conditions (geographical origin, socioeconomic situation, diet) and comorbidities
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2021
Primary Completion (Actual)
October 12, 2021
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
March 16, 2021
First Submitted That Met QC Criteria
March 22, 2021
First Posted (Actual)
March 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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