To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica
• Collaborators: Consorci Sanitari de Terrassa; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Hospital Sant Joan de Deu; Hospital Universitario 12 de Octubre; Hospital Universitario La Fe; Hospital Universitario La Paz; Hospital Universitario Puerta del Mar; Hospital Vall d'Hebron
• Treatments: Tocolytic Agents

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).