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

NCT04831086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2025-03-12

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Steroid Drug

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

DRUG

Tocolytic Agents

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

Sponsors & Collaborators

  • Hospital Vall d'Hebron

    collaborator OTHER
  • Hospital Universitario La Fe

    collaborator OTHER
  • Hospital Universitario La Paz

    collaborator OTHER
  • Hospital Universitario 12 de Octubre

    collaborator OTHER
  • Consorci Sanitari de Terrassa

    collaborator OTHER
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    collaborator OTHER
  • Hospital Universitario Puerta del Mar

    collaborator OTHER
  • Hospital Sant Joan de Deu

    collaborator OTHER
  • Germans Trias i Pujol Hospital

    collaborator OTHER
  • University Hospital Virgen de las Nieves

    collaborator OTHER
  • Hospital Clínico Universitario Lozano Blesa

    collaborator OTHER
  • Parc Taulí Hospital Universitari

    collaborator OTHER
  • Complexo Hospitalario Universitario de A Coruña

    collaborator OTHER
  • Hospital Son Llatzer

    collaborator OTHER
  • Hospital Universitari Joan XXIII de Tarragona.

    collaborator OTHER
  • Hospital Universitario de Torrejón

    collaborator UNKNOWN
  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Principal Investigators

  • Teresa Cobo, MD, PhD · Fundació Recerca Biomèdica Clínica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2024-10-30
Completion
2024-12-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831086 on ClinicalTrials.gov