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

Fundacion Clinic per a la Recerca Biomédica247 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

247

Conditions

Preterm Birth Preterm Labor Intra-amniotic Infection Amniocentesis Affecting Fetus or Newborn

Interventions

Steroid DrugDRUG

Steroids doses will be optimized in the intervention group according the risk based on predictive models

Tocolytic AgentsDRUG

Tocolysis duration will be optimized in the intervention group according the risk based on predictive models

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Fundació Recerca Biomèdica Clínica

Barcelona, Spain

Outcomes

Primary Outcomes

Antenatal steroid doses

Number of antenatal steroid doses administered

Time frame: through study completion, an average of 1 year

Secondary Outcomes

maternal stay length

Maternal length of hospital stay (in days).

Time frame: through study completion, an average of 1 year

Clinical chorioamnionitis

Clinical chorioamnionitis occurrence defined by the presence of maternal fever \>=38ºC, fetal tachycardia \> 160 bpm, leukocytes \> 14000/m2 without steroids effect and cervical purulent fluid

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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