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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04374916
Other study ID # 7353
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 11, 2020
Est. completion date August 25, 2022

Study information

Verified date September 2021
Source University Hospital, Strasbourg, France
Contact Antoine KOCH, PHD
Phone +33 3 88 12 75 03
Email antoine.koch@chru-strabourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 25, 2022
Est. primary completion date August 25, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Twin pregnancy - 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
France Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome measure will be the occurrence of a premature delivery within 7 days after patient's inclusion. The outcome measure is assessed at visit 2 (day 7), 7 days after the inclusion visit.
Secondary Collection of the occurrence of a premature delivery within 7 days of inclusion, then calculation of specificity, positive and negative predictive values. At visit 2, Day 7 (7 days after inclusion visit V0)
Secondary 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. At visit 1, Day 2 (2 days after inclusion visit ) and D14 (14 days after inclusion visit )
Secondary Collection of the number of invalid results requiring restarting the Premaquick test. At the Inclusion visit Visit 0 (Day 0)
Secondary 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. At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
Secondary a new calculation algorithm to predict the risk of preterm delivery, based on the results observed in this study. At visit 1 (Day 2) - Visit 2 (Day 7) and after end of research visit (Day 14)
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