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

Phase 3

Completed

• Conditions: Preterm Birth; Amniocentesis Affecting Fetus or Newborn; Preterm Labor; Intra-amniotic Infection
• Interventions: Drug: Steroid Drug; Drug: Tocolytic Agents

• Registration Number: NCT04831086
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-05
• Study Start: 2021-05-05
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 247

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Steroid Drug	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
Intervention	Tocolytic Agents	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

Primary Outcome Measures

Name	Time	Method
Antenatal steroid doses	through study completion, an average of 1 year	Number of antenatal steroid doses administered

Secondary Outcome Measures

Name	Time	Method
maternal stay length	through study completion, an average of 1 year	Maternal length of hospital stay (in days).
Clinical chorioamnionitis	through study completion, an average of 1 year	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

Trial Locations

Locations (1)

Fundació Recerca Biomèdica Clínica; 🇪🇸 Barcelona, Spain