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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04831086
Other study ID # OPTIM-PTL
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 5, 2021
Est. completion date December 30, 2023

Study information

Verified date May 2022
Source Fundacion Clinic per a la Recerca Biomédica
Contact Teresa Cobo, MD,PhD
Phone +34 93 227 54 00
Email tcobo@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date December 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Steroid Drug
Steroids doses will be optimized in the intervention group according the risk based on predictive models
Tocolytic Agents
Tocolysis duration will be optimized in the intervention group according the risk based on predictive models

Locations

Country Name City State
Spain Fundació Recerca Biomèdica Clínica Barcelona

Sponsors (13)

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

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martínez-Portilla RJ, Gratacós E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microb — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Tocolysis duration Tocolysis duration (in days) through study completion, an average of 1 year
Other Gestational age at delivery Gestational age at delivery through study completion, an average of 1 year
Other Spontaneous delivery within 7 days after admission Spontaneous delivery within 7 days after admission (yes/no), through study completion, an average of 1 year
Other Microbial invasion of amniotic cavity 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 through study completion, an average of 1 year
Other Cost analyses 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. through study completion, an average of 1 year
Other Maternal morbidity Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need for transfusion, maternal death. through study completion, an average of 1 year
Other Neonatal length of hospital stay Neonatal length of hospital stay (days) through study completion, an average of 1 year
Other Neonatal birthweight (in grams) Neonatal anthropometric measurements through study completion, an average of 1 year
Other height (in centimeters) Neonatal anthropometric measurements through study completion, an average of 1 year
Other cephalic, thoracic and abdominal perimeters (in millimeters) Neonatal anthropometric measurements through study completion, an average of 1 year
Other arm circumference (in centimeters) Neonatal anthropometric measurements through study completion, an average of 1 year
Other Adverse neonatal outcome 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. through study completion, an average of 1 year
Primary Antenatal steroid doses Number of antenatal steroid doses administered through study completion, an average of 1 year
Secondary maternal stay length Maternal length of hospital stay (in days). through study completion, an average of 1 year
Secondary 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 through study completion, an average of 1 year
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