To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis (OPTIM-PTL)
Preterm Birth, Preterm Labor, Intra-amniotic Infection
About this trial
This is an interventional treatment trial for Preterm Birth
Eligibility 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).
Sites / Locations
- Fundació Recerca Biomèdica ClínicaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Control
In the intervention arm, the management will be optimized according to the risk of the predictive model. The predictive model of intra-amniotic infection includes maternal C-reactive protein (CRP) (in mg/L) and amniotic fluid glucose (in mg/dL), and the predictive model of spontaneous preterm delivery within 7 days includes gestational age (in weeks), cervical length (in mm), amniotic fluid glucose (in mg/dL) and Interleukin (IL)-6 (in a log10 scale). High risk will be defined when the risk is > 10% in the predictive model of spontaneous delivery in 7 days and > 20% in the predictive model of intra-amniotic infection: If low-risk: we will optimize the standard management reducing the dose of steroids (e.g not administering second doses), tocolysis duration and facilitating discharge home. If high-risk: we will follow the standard management of each center and we will treat with antibiotics
In the control arm the standard management of each center will be followed regarding doses of steroids, duration of tocolysis or maternal stay length duration.