Premature BirthCONFINéoNCT04605172
Lockdown Impact on Spontaneous Premature Birth in a Level III NICU
An observational study of Premature Birth and Preterm Labor, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Premature Birth, Preterm Labor
- What is being tested?
- hospitalization for premature birth
- How many people
- 812 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2020to 30 Nov 2021
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: All premature newborns born before 37 SA and care for by the level III NICU of the Maternité Régionale Universitaire de Nancy, over time periods from March 1 to June 1 of the years 2015 to 2020.
Who may be able to join
- Any prematurely born infant before 37 SA and care for by the level III NICU, over the predefined periods.
Who cannot join
- non premature newborn
Trial locations and contacts
1 site in 1 country.
France1 site
Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, 54035
About this study
Official title: The Impact of the SARS CoV-2 Lockdown Policy on Spontaneous Premature Birth at the Regional University Maternity Hospital of Nancy
Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation.
It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed.
Read more
The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure.
During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region.
Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.
- Conditions
- Premature Birth, Preterm Labor
- Being tested
- hospitalization for premature birth
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospitalization for premature birthOther
Number of inborn and outborn infants prematurely born during a specific period of time
| Study group | Role | What they receive |
|---|---|---|
| Lockdown Group | newborn born prematurely during confinement (1st March - 1st June 2020) Receives: Other: hospitalization for premature birth | |
| Control group | newborn born prematurely in comparative years over the same period (1st March - 1st June from 2015 to 2019) Receives: Other: hospitalization for premature birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of confinement on the rate of spontaneous prematurity at the Regional University Maternity Hospital of Nancy (MRUN)
Number of prematurely born infants
Measured: baseline
Secondary outcomes (3)
Evaluate the impact of confinement on the type of prematurity rate: spontaneous or not
Number of infants born by vaginal delivery or cesarean section
Measured: baseline
Evaluate the impact of confinement on the outborn rate managed by the Regional Neonatal transport team for prematurity
Number of infants transferred from referring hospitals to the level III NICU for prematurity
Measured: baseline
Evaluate the type of prematurity over the period of confinement
Diagnosis evaluation of prematurely born infants during lockdown period
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start2 Nov 2020
- Primary completion30 Apr 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605172
- Sponsor's protocol ID
- 2020PI168
- Acronym
- CONFINéo
- Status last verified
- Mar 2022
- First submitted
- 22 Oct 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the SARS CoV-2 Lockdown Policy on Spontaneous Premature Birth at the Regional University Maternity Hospital of Nancy
- ClinicalTrials.gov ID
- NCT04605172
- Acronym / sponsor ID
- CONFINéo / 2020PI168
- Conditions
- Premature Birth, Preterm Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 27 Oct 2020 (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.
Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular and painful uterine contractions associated with a change in the cervix, between 22 and 36 weeks of gestation.
It has been shown that the risk of spontaneous prematurity increases particularly in case of working over 40 hours per week, hard physically conditions, or prolonged daily transport time. Rest is one of the most efficient measure to prevent PL and should be proposed to all pregnant women, and combined with other therapies such as tocolysis or cerclage when needed.
The very particular period of lockdown during the COVID-19 pandemic had pregnant women to drastically reduce their activity. They suspended their work and stayed home for various reasons such as pregnancy in progress, children at home, and also collective reasons such as teleworking or workplace closure.
During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less spontaneous prematurity have been suspected by the neonatology and obstetrics teams throughout the Lorraine region.
Our study aims to objectively confirm this observation. In this investigation we aim to find a relationship between lockdown, PL and spontaneous prematurity which would need to re-evaluate public health recommendations for pregnant women outside the lockdown.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lockdown Group | – | Other: hospitalization for premature birthnewborn born prematurely during confinement (1st March - 1st June 2020) |
| Control group | – | Other: hospitalization for premature birthnewborn born prematurely in comparative years over the same period (1st March - 1st June from 2015 to 2019) |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All premature newborns born before 37 SA and care for by the level III NICU of the Maternité Régionale Universitaire de Nancy, over time periods from March 1 to June 1 of the years 2015 to 2020.
Key inclusion criteria (1 listed)
- Any prematurely born infant before 37 SA and care for by the level III NICU, over the predefined periods.
Key exclusion criteria (1 listed)
- non premature newborn
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 |
|---|---|---|
| hospitalization for premature birthNumber of inborn and outborn infants prematurely born during a specific period of time | Other | Control group, Lockdown Group |
Primary outcome
Evaluate the impact of confinement on the rate of spontaneous prematurity at the Regional University Maternity Hospital of Nancy (MRUN)
Time frame: baseline
Number of prematurely born infants
3 secondary outcomes
Evaluate the impact of confinement on the type of prematurity rate: spontaneous or not
Time frame: baseline
Evaluate the impact of confinement on the outborn rate managed by the Regional Neonatal transport team for prematurity
Time frame: baseline
Evaluate the type of prematurity over the period of confinement
Time frame: baseline
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 10 Mar 2022.
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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 Premature Birth and Preterm Labor, run by Central Hospital, Nancy, France 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 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: finished, as of the sponsor's last update on 10 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?
Evaluate the impact of confinement on the rate of spontaneous prematurity at the Regional University Maternity Hospital of Nancy (MRUN) (time frame: baseline). 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 10 Mar 2022.