Delivery ComplicationNidaModaNCT05845879
Obstetrical Outcomes for Planned Deliveries in a French Birth Center
An observational study of Delivery Complication, run by Central Hospital, Nancy, France.
Trial summary
The main objective of this work is to study the obstetrical and neonatal outcomes of women who planned to deliver in the birth centre of Nancy. The birth centre of Nancy is one of the nine french birth centres opened since 2015 on an experimental basis. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery Complication
- What is being tested?
- delivery
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 May 2024
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All women who want to deliver at the birth center "Un nid pour naître" since 01/01/2020 to 31/12/2022
Who may be able to join
- women who want to deliver at the birth center "Un nid pour naître"
Who cannot join
- Refusal to participate in the study.
About this study
The main objective of this work is to study the obstetrical and neonatal outcomes of women who planned to deliver in the birth centre of Nancy.
The birth centre of Nancy is one of the nine french birth centres opened since 2015 on an experimental basis.
The women who plan to deliver at the birth centre must meet several conditions according to their medical history, pregnancy follow-up, and delivery progress.
The women can be transferred before, during or after (pre-, per- or post-) delivery to the hospital.
- Conditions
- Delivery Complication
- Being tested
- delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deliveryOther
delivery
| Study group | Role | What they receive |
|---|---|---|
| Women who planned to deliver at the brith center "un nid pour naître" | Women who planned to deliver at the brith center "un nid pour naître" Receives: Other: delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the cesarean birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
rate of cesarean section
Measured: 4 years
Comparison of the instrumental birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
rate of instrumental birth (vacuum or forceps delivery)
Measured: 4 years
Comparison of the post-partum haemorrhage rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
rate of post-partum haemorrhage define by blood loss >= 500 cc
Measured: 4 years
Secondary outcomes (4)
Comparison of the antepartum or peripartum stillbirth rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
Measured: 4 years
Comparison of the hypoxemic encephalopathy rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
Measured: 4 years
Comparison of the five-minute Apgar score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Apgar score is a score that records the physical condition of a baby just after it is born, with ten points being the highest possible score and zero point the lowest.
Measured: 4 years
Comparison of the umbilical artery blood pH score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery ComplicationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu DAP, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845879
- Sponsor's protocol ID
- 2022PI173
- Acronym
- NidaModa
- Status last verified
- May 2023
- First submitted
- 9 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical Outcomes for Planned Deliveries in a French Birth Center
- ClinicalTrials.gov ID
- NCT05845879
- Acronym / sponsor ID
- NidaModa / 2022PI173
- Conditions
- Delivery Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 6 May 2023 (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.
The main objective of this work is to study the obstetrical and neonatal outcomes of women who planned to deliver in the birth centre of Nancy.
The birth centre of Nancy is one of the nine french birth centres opened since 2015 on an experimental basis.
The women who plan to deliver at the birth centre must meet several conditions according to their medical history, pregnancy follow-up, and delivery progress.
The women can be transferred before, during or after (pre-, per- or post-) delivery to the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who planned to deliver at the brith center "un nid pour naître" | – | Other: deliveryWomen who planned to deliver at the brith center "un nid pour naître" |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All women who want to deliver at the birth center "Un nid pour naître" since 01/01/2020 to 31/12/2022
Key inclusion criteria (1 listed)
- women who want to deliver at the birth center "Un nid pour naître"
Key exclusion criteria (1 listed)
- Refusal to participate in the study.
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 |
|---|---|---|
| deliverydelivery | Other | Women who planned to deliver at the brith center "un nid pour naître" |
Primary outcome
Comparison of the cesarean birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time frame: 4 years
rate of cesarean section
Comparison of the instrumental birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time frame: 4 years
rate of instrumental birth (vacuum or forceps delivery)
Comparison of the post-partum haemorrhage rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time frame: 4 years
rate of post-partum haemorrhage define by blood loss >= 500 cc
4 secondary outcomes
Comparison of the antepartum or peripartum stillbirth rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
Time frame: 4 years
Comparison of the hypoxemic encephalopathy rate of women who planned to deliver in the birth center according to the final place of labor (hospital or birth centre).
Time frame: 4 years
Comparison of the five-minute Apgar score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time frame: 4 years
Comparison of the umbilical artery blood pH score of babies from women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre).
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery Complication, run by Central Hospital, Nancy, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Comparison of the cesarean birth rate of women who planned to deliver in the birth centre according to the final place of labor (hospital or birth centre). (time frame: 4 years). The study lists 3 primary outcomes in all. 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 23 May 2023.