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Lockdown Impact on Spontaneous Premature Birth in a Level III NICU (CONFINéo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605172
Recruitment Status : Completed
First Posted : October 27, 2020
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Jean-Michel HASCOET, Central Hospital, Nancy, France

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment
Premature Birth Preterm Labor Other: hospitalization for premature birth

Study Design
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Study Type : Observational
Actual Enrollment : 812 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Impact of the SARS CoV-2 Lockdown Policy on Spontaneous Premature Birth at the Regional University Maternity Hospital of Nancy
Actual Study Start Date : November 2, 2020
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : November 30, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Lockdown Group
newborn born prematurely during confinement (1st March - 1st June 2020)
 Other: hospitalization for premature birth
Number of inborn and outborn infants prematurely born during a specific period of time
Control group
newborn born prematurely in comparative years over the same period (1st March - 1st June from 2015 to 2019)
 Other: hospitalization for premature birth
Number of inborn and outborn infants prematurely born during a specific period of time


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluate the impact of confinement on the type of prematurity rate: spontaneous or not [ Time Frame: baseline ]
    Number of infants born by vaginal delivery or cesarean section

  2. Evaluate the impact of confinement on the outborn rate managed by the Regional Neonatal transport team for prematurity [ Time Frame: baseline ]
    Number of infants transferred from referring hospitals to the level III NICU for prematurity

  3. Evaluate the type of prematurity over the period of confinement [ Time Frame: baseline ]
    Diagnosis evaluation of prematurely born infants during lockdown period


Eligibility Criteria
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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Any prematurely born infant before 37 SA and care for by the level III NICU, over the predefined periods.

Exclusion Criteria:

  • non premature newborn
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605172


Locations
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France
Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, France, 54035
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Responsible Party: Jean-Michel HASCOET, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04605172    
Other Study ID Numbers: 2020PI168
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications