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

Study Overview
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Brief Summary
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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
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To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes. It is a cost-effective strategy. It improves neonatal outcome (in premature newborns <30 weeks), and reduces infectious maternal morbility. It improves neurodevelopmental outcome at 1.2 and 5 years.

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

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

Intervention / Treatment
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* Drug: Steroid Drug
* Drug: Tocolytic Agents


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor and intact membranes between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Drug: Steroid Drug<br>* Steroids doses will be optimized in the intervention group according the risk based on predictive models<br>Drug: Tocolytic Agents<br>* Tocolysis duration will be optimized in the intervention group according the risk based on predictive models<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antenatal steroid doses | Number of antenatal steroid doses administered | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal stay length | Maternal length of hospital stay (in days). | 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 | through study completion, an average of 1 year |