Threatened Preterm LaborPREMAQUICKNCT04374916
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
A study testing Premaquick® and PARTOSURE® in people with Threatened Preterm Labor and Preterm Delivery, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Threatened preterm labor (TPL) is defined by cervical changes and regular and painful uterine contractions occurring between 24 and 36 + 6 weeks of gestation that may or may not lead to premature labor and delivery. There is no reliable way to predict preterm delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Threatened Preterm Labor, Preterm Delivery
- What is being tested?
- Premaquick® and PARTOSURE®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2020to Sep 2026
- 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
- Patient aged > 18 years (with no upper age limit)
- 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
Who cannot join
- Twin pregnancy
- Sexual intercourse less than 24 hours from inclusion
- Cervical cerclage
- Abundant metrorrhagia
- Premature rupture of membranes
- Pre-eclampsia
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Antoine KOCH, PHD, 03 88 12 75 03
About this study
Threatened preterm labor (TPL) is defined by cervical changes and regular and painful uterine contractions occurring between 24 and 36 + 6 weeks of gestation that may or may not lead to premature labor and delivery. There is no reliable way to predict preterm delivery.
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.
- Conditions
- Threatened Preterm Labor, Preterm Delivery
- Being tested
- Premaquick®, PARTOSURE®
- Keywords
- Threatened preterm labor, Preterm Delivery, Preterm birth, IGFBP-1
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premaquick®Device
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®Device
An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.
| Study group | Role | What they receive |
|---|---|---|
| Partosure® test + Premaquick® test | Experimental | All patients will have the same 2 tests. Receives: Device: Premaquick®; Device: PARTOSURE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion.
Measured: The outcome measure is assessed at visit 2 (day 7), 7 days after the inclusion visit.
Secondary outcomes (5)
Collection of the occurrence of a premature delivery within 7 days of inclusion, then calculation of specificity, positive and negative predictive values.
Measured: At visit 2, Day 7 (7 days after inclusion visit V0)
Collection of the occurrence of a premature delivery on Day 2 and Day 14 following the inclusion, then calculation of the sensitivities, specificities, positive and negative predictive values.
Measured: At visit 1, Day 2 (2 days after inclusion visit ) and D14 (14 days after inclusion visit )
Collection of the number of invalid results requiring restarting the Premaquick test.
Measured: At the Inclusion visit Visit 0 (Day 0)
Collection of premature deliveries at different times (2, 7 and 14 days after inclusion visit), then comparison of the sensitivities and specificities of the two tests at different times.
Measured: At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
a new calculation algorithm to predict the risk of preterm delivery, based on the results observed in this study.
Measured: At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start11 Aug 2020
- Primary completion4 Apr 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened Preterm LaborStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374916
- Sponsor's protocol ID
- 7353
- Acronym
- PREMAQUICK
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided