Pregnancy AnemiaANEMIANCT04812821
Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital
An observational study of Pregnancy Anemia, run by Hopital Nord Franche-Comte at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Anemia
- What is being tested?
- questionnaire
- How many people
- 1,177 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2021to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presenting eligibility criteria and giving birth at NFC Hospital
Who may be able to join
- > 18 years
- Delivery at Nord Franche-Comte Hospital
- Delivery ≥ 32 weeks of amenorrhea
- Informed patient and non-opposition of participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pregnancy Anemia
- Being tested
- questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire post delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Secondary outcomes (1)
Risk factors underlying anemia during delivery with a large questionnaire
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start12 Apr 2021
- Primary completion12 Oct 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812821
- Sponsor's protocol ID
- 2019-02
- Acronym
- ANEMIA
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital
- ClinicalTrials.gov ID
- NCT04812821
- Acronym / sponsor ID
- ANEMIA / 2019-02
- Conditions
- Pregnancy Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,177 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting eligibility criteria and giving birth at NFC Hospital
Key inclusion criteria (4 listed)
- > 18 years
- Delivery at Nord Franche-Comte Hospital
- Delivery ≥ 32 weeks of amenorrhea
- Informed patient and non-opposition of participation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairequestionnaire post delivery | Other | – |
Primary outcome
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
1 secondary outcome
Risk factors underlying anemia during delivery with a large questionnaire
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Anemia, run by Hopital Nord Franche-Comte at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the proportion of patients presenting anemia during delivery (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.