NCT04831086

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.5 years

First QC Date

March 24, 2021

Last Update Submit

March 11, 2025

Conditions

Preterm BirthPreterm LaborIntra-amniotic InfectionAmniocentesis Affecting Fetus or Newborn

Outcome Measures

Primary Outcomes (1)

  • Antenatal steroid doses

    Number of antenatal steroid doses administered

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • maternal stay length

    through study completion, an average of 1 year

  • Clinical chorioamnionitis

    through study completion, an average of 1 year

Other Outcomes (12)

  • Tocolysis duration

    through study completion, an average of 1 year

  • Gestational age at delivery

    through study completion, an average of 1 year

  • Spontaneous delivery within 7 days after admission

    through study completion, an average of 1 year

  • +9 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Steroid DrugDrug: Tocolytic Agents

Control

NO INTERVENTION

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.

Interventions

Steroid DrugDRUG

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

Intervention
Tocolytic AgentsDRUG

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

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació Recerca Biomèdica Clínica

Barcelona, 08828, Spain

Location

Related Publications (2)

  • Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martinez-Portilla RJ, Gratacos E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity in women with preterm labor. Am J Obstet Gynecol. 2020 Sep;223(3):421.e1-421.e14. doi: 10.1016/j.ajog.2020.02.049. Epub 2020 Mar 5.

    PMID: 32147290RESULT

  • Cobo T, Aldecoa V, Bartha JL, Bugatto F, Paz Carrillo-Badillo M, Comas C, Diago-Almeda V, Ferrero S, Goya M, Herraiz I, Marti-Malgosa L, Olivella A, Paules C, Vives A, Figueras F, Palacio M, Gratacos E; OPTIM-PTL group. Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study). BMJ Open. 2021 Sep 28;11(9):e054711. doi: 10.1136/bmjopen-2021-054711.

    PMID: 34588268DERIVED

Related Links

MeSH Terms

Conditions

Premature BirthObstetric Labor, Premature

Interventions

Tocolytic Agents

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • Teresa Cobo, MD, PhD

    Fundació Recerca Biomèdica Clínica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Specialist

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 5, 2021

Study Start

May 5, 2021

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available after the end of the study
Access Criteria
https://apps.sjdhospitalbarcelona.org/redcap/

Locations

ES(1)