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NCT04605172: CONFINéo
Lockdown Impact on Spontaneous Premature Birth in a Level III NICU
trial testing hospitalization for premature birth in Premature Birth in 812 participants. Completed in 30 November 2021.
30 April 2021
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 812 |
| Start date | 2 November 2020 |
| Primary completion | 30 April 2021 |
| Estimated completion | 30 November 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- hospitalization for premature birth
Conditions studied
- Premature Birth — all drugs for Premature Birth →
- Preterm Labor — all drugs for Preterm Labor →
Sponsor
Central Hospital, Nancy, France
Who can join
Adults 0 Days to 28 Days, any sex, with Premature Birth or Preterm Labor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04605172
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04605172 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 10 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04605172.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing