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

Primary Purpose

Preterm Birth, Preterm Labor, Intra-amniotic Infection

Status

Recruiting

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Steroid Drug

Tocolytic Agents

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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).

Sites / Locations

Fundació Recerca Biomèdica ClínicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

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

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.

Outcomes

Primary Outcome Measures

Antenatal steroid doses

Number of antenatal steroid doses administered

Secondary Outcome Measures

maternal stay length

Maternal length of hospital stay (in days).

Clinical chorioamnionitis

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

Full Information

NCT ID

NCT04831086

First Posted

March 24, 2021

Last Updated

May 11, 2022

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Collaborators

Hospital Vall d'Hebron, Hospital Universitario La Fe, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Consorci Sanitari de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Universitario Puerta del Mar, Hospital Sant Joan de Deu, Germans Trias i Pujol Hospital, University Hospital Virgen de las Nieves, Hospital Clínico Universitario Lozano Blesa, Parc Taulí Hospital Universitari

1. Study Identification

Unique Protocol Identification Number

NCT04831086

Brief Title

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

Acronym

OPTIM-PTL

Official Title

To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 5, 2021 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundacion Clinic per a la Recerca Biomédica

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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: Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes. It is a cost-effective strategy. It improves neonatal outcome (in premature newborns <30 weeks), and reduces infectious maternal morbility. It improves neurodevelopmental outcome at 1.2 and 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Steroid Drug

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tocolytic Agents

Intervention Description

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

Primary Outcome Measure Information:

Title

Antenatal steroid doses

Description

Number of antenatal steroid doses administered

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

maternal stay length

Description

Maternal length of hospital stay (in days).

Time Frame

through study completion, an average of 1 year

Title

Clinical chorioamnionitis

Description

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

Time Frame

through study completion, an average of 1 year

Other Pre-specified Outcome Measures:

Title

Tocolysis duration

Description

Tocolysis duration (in days)

Time Frame

through study completion, an average of 1 year

Title

Gestational age at delivery

Description

Gestational age at delivery

Time Frame

through study completion, an average of 1 year

Title

Spontaneous delivery within 7 days after admission

Description

Spontaneous delivery within 7 days after admission (yes/no),

Time Frame

through study completion, an average of 1 year

Title

Microbial invasion of amniotic cavity

Description

Microbial invasion of amniotic cavity (yes/no) defined by the presence of a positive amniotic fluid culture, detection of 16S rRNA gene or visualization of microorganisms at the Gram stain

Time Frame

through study completion, an average of 1 year

Title

Cost analyses

Description

Cost analyses: The following resource items will be collected: maternal and neonatal admissions, method of delivery, type of induction, outpatient visits, emergency visits, medication, surgical procedures, maternal stay length.

Time Frame

through study completion, an average of 1 year

Title

Maternal morbidity

Description

Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need for transfusion, maternal death.

Time Frame

through study completion, an average of 1 year

Title

Neonatal length of hospital stay

Description

Neonatal length of hospital stay (days)

Time Frame

through study completion, an average of 1 year

Title

Neonatal birthweight (in grams)

Description

Neonatal anthropometric measurements

Time Frame

through study completion, an average of 1 year

Title

height (in centimeters)

Description

Neonatal anthropometric measurements

Time Frame

through study completion, an average of 1 year

Title

cephalic, thoracic and abdominal perimeters (in millimeters)

Description

Neonatal anthropometric measurements

Time Frame

through study completion, an average of 1 year

Title

arm circumference (in centimeters)

Description

Neonatal anthropometric measurements

Time Frame

through study completion, an average of 1 year

Title

Adverse neonatal outcome

Description

A composite adverse neonatal outcome (yes/no) defined as the presence or one or more of the following outcomes: fetal or neonatal death, early onset sepsis, moderate/severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, periventricular leukomalacia, surgical necrotizing enterocolitis, retinopathy requiring laser treatment.

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Teresa Cobo, MD,PhD

Phone

+34 93 227 54 00

Ext

7281

tcobo@clinic.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Ana B Sánchez García, Bsc

Phone

+34 93 227 54 00

Ext

7281

absanchez@clinic.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teresa Cobo, MD, PhD

Organizational Affiliation

Fundació Recerca Biomèdica Clínica

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fundació Recerca Biomèdica Clínica

City

Barcelona

ZIP/Postal Code

08828

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Teresa Cobo, MD, PhD

Phone

34932275600

tcobo@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all collected IPD

IPD Sharing Time Frame

Data will be available after the end of the study

IPD Sharing Access Criteria

https://apps.sjdhospitalbarcelona.org/redcap/

Citations:

PubMed Identifier

32147290

Citation

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.

Results Reference

result

PubMed Identifier

34588268

Citation

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.

Results Reference

derived

Links:

URL

https://doi.org/10.1016/j.ajog.2020.02.049

Description

Predictive models of spontaneous delivery within 7 days and of intra-amniotic infections description

Learn more about this trial

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

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