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Clinical Trials/NCT03144141
NCT03144141
Completed
Not Applicable

Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

Centre Hospitalier Universitaire, Amiens1 site in 1 country100 target enrollmentSeptember 12, 2017
ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
100
Locations
1
Primary Endpoint
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2017
End Date
February 13, 2019
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Patient minor,
  • Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
  • Patient under tutelage or curatorship or deprived of public law

Outcomes

Primary Outcomes

Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery

Time Frame: 15 days

Study Sites (1)

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