Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
NCT ID: NCT04374916
Last Updated: 2021-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-08-11
2022-08-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study's hypothesis is that the Premaquick® test can improve the prediction of preterm delivery.
The investigators also want to compare this test with the Partosure® (Placental alpha microglobulin-1) test.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cervical Softening and the Prediction of Preterm Birth
NCT05477381
Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?
NCT05837390
Aspiration Technique-based Device for Preterm Labor
NCT05355649
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
NCT02716909
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
NCT03418012
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Partosure® test + Premaquick® test
All patients will have the same 2 tests.
Premaquick®
Vaginal secretions are collected prior to any vaginal or endovaginal ultrasound examination to avoid false positives, with the nylon swab provided with the test (placed in the posterior fornix of the vagina for 10 seconds).Then the samples are tested with the Premaquick test. Results are obtained in 10 minutes.
PARTOSURE®
An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Premaquick®
Vaginal secretions are collected prior to any vaginal or endovaginal ultrasound examination to avoid false positives, with the nylon swab provided with the test (placed in the posterior fornix of the vagina for 10 seconds).Then the samples are tested with the Premaquick test. Results are obtained in 10 minutes.
PARTOSURE®
An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient affiliated to a social security health regime
* Between 24 and 33 + 6 weeks of gestation (amenorrhea)
* Singleton pregnancy
* Patient with a TPL: Uterine contractions during the last 24 hours felt by the patient, painful or not, and cervix less than or equal to 25 mm on endovaginal ultrasound
* Having signed an informed consent form
Exclusion Criteria
* Sexual intercourse less than 24 hours from inclusion
* Cervical cerclage
* Abundant metrorrhagia
* Premature rupture of membranes
* Pre-eclampsia
* Congenital malformation
* Presence of a placenta previa
* Pelvic examination in the previous 24 hours (compared to inclusion)
* Patient under guardianship, curatorship or safeguard of justice
* Persons deprived of their liberty by judicial or administrative decision
* Persons under psychiatric care under duress
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Strasbourg, France
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Antoine KOCH, PHD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7353
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.