Status:
COMPLETED
To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Collaborating Sponsors:
Hospital Vall d'Hebron
Hospital Universitario La Fe
Conditions:
Preterm Birth
Preterm Labor
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes
Detailed Description
To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: 1. Optimises antenatal management (regarding steroids, tocoly...
Eligibility Criteria
Inclusion
- Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
Exclusion
- Women who do no accept to be part of the study
- Maternal age \< 18 years
- Multiple gestations
- Clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºC), fetal tachycardia (\>160 heart beat per minute \>10 minutes), maternal White blood cells \> 15000/mm3 (not justified by the administration of antenatal steroids).
- Cervical dilatation \> 3 cm
- Major structural malformations of fetal complications that are related to neurodevelopmental impairment.
- Technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration).
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT04831086
Start Date
May 5 2021
End Date
December 30 2024
Last Update
March 12 2025
Active Locations (1)
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1
Fundació Recerca Biomèdica Clínica
Barcelona, Spain, 08828