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

NCT ID: NCT03144141

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-12

Study Completion Date

2019-02-13

Brief Summary

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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

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Conditions

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Preterm Birth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with the diagnosis of threat of uterine delivery

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status

Countries

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France

References

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https://theses.fr/2019COMP2489 Évaluation de l'électrohystérogramme pour la surveillance et le diagnostic des femmes à risque d'accouchement prématuré

Reference Type RESULT

Other Identifiers

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PI2016_843_0011

Identifier Type: -

Identifier Source: org_study_id

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