Lockdown Impact on Spontaneous Premature Birth in a Level III NICU

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of the SARS CoV-2 Lockdown Policy on Spontaneous Premature Birth at the Regional University Maternity Hospital of Nancy

Conditions
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Premature Birth, Preterm Labor

Intervention / Treatment
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* Other: hospitalization for premature birth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lockdown Group<br>newborn born prematurely during confinement (1st March - 1st June 2020) | Other: hospitalization for premature birth<br>* Number of inborn and outborn infants prematurely born during a specific period of time<br>|
| Control group<br>newborn born prematurely in comparative years over the same period (1st March - 1st June from 2015 to 2019) | Other: hospitalization for premature birth<br>* Number of inborn and outborn infants prematurely born during a specific period of time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of confinement on the type of prematurity rate: spontaneous or not | Number of infants born by vaginal delivery or cesarean section | 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 | baseline | 
| Evaluate the type of prematurity over the period of confinement | Diagnosis evaluation of prematurely born infants during lockdown period | baseline |