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

Preterm Birth Clinical Trial

— RACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144141
• Other study ID #: PI2016_843_0011
• Status: Completed
• Phase: N/A
• Start date: September 12, 2017
• Est. completion date: February 13, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery		15 days