Lockdown Impact on Spontaneous Premature Birth in a Level III NICU

Premature Birth Clinical Trial

— CONFINéo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605172
• Other study ID #: 2020PI168
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: November 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Other:
• hospitalization for premature birth
Number of inborn and outborn infants prematurely born during a specific period of time

Locations

Country	Name	City	State
France	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evaluate the type of prematurity over the period of confinement	Diagnosis evaluation of prematurely born infants during lockdown period	baseline