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

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.

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 Overview

• Status: Completed
• Conditions: Premature Birth; Preterm Labor
• Intervention / Treatment: Other: hospitalization for premature birth

• Study Type: Observational
• Enrollment (Actual): 812

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54035
      • Maternite Regionale Universitaire CHRU NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (ACTUAL): October 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 2020PI168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No