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OpenTrials
Completed

NCT Number: NCT04605172

Lockdown Impact on Spontaneous Premature Birth in a Level III NICU

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.

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hospitalization for premature birth

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: CONFINéo

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2020
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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