Status:
UNKNOWN
Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Threatened Preterm Labor
Preterm Delivery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 labo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04374916
Start Date
August 11 2020
End Date
August 25 2022
Last Update
October 7 2021
Active Locations (1)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091