Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery

Not Applicable

Completed

• Conditions: Preterm Birth
• Interventions: Other: Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization

• Registration Number: NCT03144141
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Study Start: 2017-09-12
• Primary Completion: 2019-02-13
• Study Completion: 2019-02-13
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with the diagnosis of threat of uterine delivery	Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization	-

Primary Outcome Measures

Name	Time	Method
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery	15 days

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France