Preterm BirthRACENCT03144141
Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
A study testing Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization in people with Preterm Birth, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2017to 13 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient minor,
- Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
- Patient under tutelage or curatorship or deprived of public law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
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.
- Conditions
- Preterm Birth
- Being tested
- Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalizationOther
Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Patients with the diagnosis of threat of uterine delivery | Other | Not described Receives: Other: Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start12 Sep 2017
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144141
- Sponsor's protocol ID
- PI2016_843_0011
- Acronym
- RACE
- Status last verified
- Nov 2025
- First submitted
- 2 May 2017
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
https://theses.fr/2019COMP2489 Évaluation de l'électrohystérogramme pour la surveillance et le diagnostic des femmes à risque d'accouchement prématuré
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Holter Electro Hysterogram (EHG) and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery
- ClinicalTrials.gov ID
- NCT03144141
- Acronym / sponsor ID
- RACE / PI2016_843_0011
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patient minor,
- Associated Obstetric Pathology: Pre-Eclampsia, Premature Rupture of Membranes (RPM)
- Patient under tutelage or curatorship or deprived of public law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalizationElectrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization | Other | Patients with the diagnosis of threat of uterine delivery |
Primary outcome
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publicationhttps://theses.fr/2019COMP2489 Évaluation de l'électrohystérogramme pour la surveillance et le diagnostic des femmes à risque d'accouchement prématuré
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization in people with Preterm Birth, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the electrical activity of the uterus (electro hysterogram) for the early diagnosis of the risk of preterm delivery (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.