Premature DeliveryPROTEOMAPNCT04067908
New Biomarkers Associated With the Risk of Premature Delivery.
A study testing 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling in people with Premature Delivery, run by University Hospital, Bordeaux.
Trial summary
Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Delivery
- What is being tested?
- 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2011to 28 Dec 2013
- Phase
- Interventional
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
- Pregnant women over 18 years of age
- Term from 22 to 33 and 6 amenorrhea weeks
- Single or twin pregnancy
- Emergency consultant, in participating centers, for a threat of premature labor defined by:
- Uterine contractions greater than or equal to 3 in 30 minutes Clinical modification of the cervix Ultrasound collar less than 25 mm
- Free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research.
- Patient affiliated to a Social Security scheme.
Who cannot join
- Premature rupture of membranes
- Placenta previa
- Vaginal haemorrhage at the time of sampling
- Uterine malformation
- Strapping, open bite
- History of strapping and or open bite
Show all 16Show fewer
- Conization
- Fetal malformation
- Associated vasorenal pathology
- Sexual intercourse less than 24h
- Gynecological examination less than 48h
- Vaginal treatment in progress
- Polyhydramnios
- Transfused-transfused syndrome
- Twin Anemia Polycythemia syndrome
- Fetoscopy during pregnancy
About this study
Official title: Study of New Biomarkers Associated With the Risk of Premature Delivery During Spontaneous Work With Intact Membranes Before 37 Weeks of Amenorrhea.
Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality.
This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.
Read the detailed description
Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. With 7.2% of premature deliveries in France, threat of premature labor remains the leading cause of maternal transfer and hospitalization. In terms of mortality, morbidity and cost, the fight against prematurity remains a national priority in terms of public health.
The diagnosis of threat of premature labor at high risk of preterm labor is difficult and clinical and laboratory criteria often remain insufficient. Measurement of the cervix by endovaginal ultrasound lacks sensitivity and specificity. Among the biological criteria, only fibronectin, which has a good negative predictive value, is used in current practice. Despite the use of these two prognostic criteria, only 40% of hospitalized patients will give birth prematurely.
Recent advances in proteomics allow us to study complex proteomes and compare them. Preliminary studies already carried out have revealed families of proteins expressed differently in situations of work or premature delivery. We therefore hypothesize that the study of a woman's vaginal proteome with threat of premature labor may reveal new markers of preterm labor. These markers could help the clinician in its therapeutic management and thus reduce hospitalizations, better target patients requiring tocolytic treatment and optimize the use of corticosteroids. In addition, variations in the proteome may help to understand the physiopathological mechanisms of premature delivery, which are necessary for the development of effective therapeutics.
- Conditions
- Premature Delivery
- Being tested
- 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling
- Keywords
- Biological markers
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 tubes of 5ml during the blood collection and 2 swabs during vaginal samplingOther
The samples taken during this study are taken at the same time as those taken in routine during the diagnosis of threat of premature labor. There are added 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling.
| Study group | Role | What they receive |
|---|---|---|
| woman giving birth prematurely | Experimental | Proteome: by liquid chromatography coupled with tandem mass spectrometry. Fibronectin: by vaginal sampling. Ultrasound of the cervix. Cytokines: ELISA kit of a panel of several cytokines. Receives: Other: 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature delivery yes/no
Premature labor is defined as a pregnancy duration of less than 37 weeks. For this study, cases of interest are : premature labor before 33 amenorrhea weeks + 6 days.
Measured: Premature delivery before 33 amenorrhea weeks + 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start7 Jun 2011
- Primary completion28 Dec 2013
- Study completion28 Dec 2013
Why it stopped: target number of subjects not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature DeliveryStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique DALLAY, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067908
- Sponsor's protocol ID
- CHUBX 2010/19
- Acronym
- PROTEOMAP
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No