NCT03144141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 12, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

May 2, 2017

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    15 days

Study Arms (1)

Patients with the diagnosis of threat of uterine delivery

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

Interventions

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

Patients with the diagnosis of threat of uterine delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient minor,
  • Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
  • Patient under tutelage or curatorship or deprived of public law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Related Publications (1)

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

    RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 8, 2017

Study Start

September 12, 2017

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations