Lockdown Impact on Spontaneous Premature Birth in a Level III NICU

NCT ID: NCT04605172

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

812 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-02

Study Completion Date

2021-11-30

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.

Detailed Description

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Conditions

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Premature Birth Preterm Labor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lockdown Group

newborn born prematurely during confinement (1st March - 1st June 2020)

hospitalization for premature birth

Intervention Type OTHER

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)

hospitalization for premature birth

Intervention Type OTHER

Number of inborn and outborn infants prematurely born during a specific period of time

Interventions

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hospitalization for premature birth

Number of inborn and outborn infants prematurely born during a specific period of time

Intervention Type OTHER

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
Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel HASCOET

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, France

Site Status

Countries

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France

Other Identifiers

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2020PI168

Identifier Type: -

Identifier Source: org_study_id

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