To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis (OPTIM-PTL)

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Completed; Phase 3

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

Treatments: Drug: Tocolytic Agents; Drug: Steroid Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT04831086

OPTIM-PTL

Details and patient eligibility

About

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

Full 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.

Enrollment: 247 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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247 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Steroid Drug

Drug: Tocolytic Agents

Control

No Intervention group

Description:

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.