Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
RACE
Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
1 other identifier
interventional
100
1 country
1
Brief Summary
Preterm delivery accounts for about 10% of deliveries in France. Prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. Despite the development of therapeutics and paraclinic examinations, this rate of preterm delivery remains stable or even increases. The use of medically assisted procreation techniques alone can not explain this rate. The analysis of the electrical activity of the uterus (electrohysterograms) is a promising technique for early diagnosis of the risk of premature delivery, allowing better management of the patients. This study is part of a European theme to study risk factors for the prevention of prematurity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedStudy Start
First participant enrolled
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedNovember 19, 2025
November 1, 2025
1.4 years
May 2, 2017
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery
15 days
Study Arms (1)
Patients with the diagnosis of threat of uterine delivery
OTHERInterventions
Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
Eligibility Criteria
You may qualify if:
- Patients arriving at maternity emergency for threat of premature birth between 26 SA and 35 SA defined by uterine contractions and a cervical modification
- Patient affiliated to a social security scheme
You may not qualify if:
- Patient minor,
- Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
- Patient under tutelage or curatorship or deprived of public law
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens Picardie
Amiens, Picardie, 80054, France
Related Publications (1)
https://theses.fr/2019COMP2489 Évaluation de l'électrohystérogramme pour la surveillance et le diagnostic des femmes à risque d'accouchement prématuré
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 8, 2017
Study Start
September 12, 2017
Primary Completion
February 13, 2019
Study Completion
February 13, 2019
Last Updated
November 19, 2025
Record last verified: 2025-11