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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT03144141

Collaborator

(none)

100

Enrollment

Location

Arm

17.1

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Other: Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 12, 2017

Actual Primary Completion Date :

Feb 13, 2019

Actual Study Completion Date :

Feb 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with the diagnosis of threat of uterine delivery	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

Arm

Intervention/Treatment

Other: Patients with the diagnosis of threat of uterine delivery

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

Outcome Measures

Primary Outcome Measures

Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT03144141

Other Study ID Numbers:

PI2016_843_0011

First Posted:

May 8, 2017

Last Update Posted:

Jul 16, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jul 16, 2020