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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2024-12-30

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

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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:

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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:

1. 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.
2. If high-risk: we will follow the standard management of each center and we will treat with antibiotics

Group Type EXPERIMENTAL

Steroid Drug

Intervention Type DRUG

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

Tocolytic Agents

Intervention Type DRUG

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Steroid Drug

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

Intervention Type DRUG

Tocolytic Agents

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes