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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with the diagnosis of threat of uterine delivery

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 2, 2017
Last Updated
July 15, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03144141
Brief Title
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
Acronym
RACE
Official Title
Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with the diagnosis of threat of uterine delivery
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
Intervention Description
Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
Primary Outcome Measure Information:
Title
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery
Time Frame
15 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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

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