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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
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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
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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
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
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
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
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
Email
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
Email
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
Email
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

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

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