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

To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)

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

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, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes.
2. It is a cost-effective strategy.
3. It improves neonatal outcome (in premature newborns <30 weeks), and reduces infectious maternal morbility.
4. It improves neurodevelopmental outcome at 1.2 and 5 years.

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).