To individualise management of women in preterm labor

OPTIM-PTL study: Optimization of the treatment of pregnant women with preterm labor and intact membranes applying multivariate prediction models - OPTIM-PTL

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005202-26-ES

Enrollment

370

Registered

2026-01-22

Start date

2021-02-12

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth

Interventions

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Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 370 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1- women who do not accept to be part of the study; 2- maternal age 160 heart beat per minute > 10 minutes), maternal White blood cells > 15000/mm3 (not justified by the administration of antenatal steroids) 5- cervical dilatation > 3 cm; 6- major structural malformations of fetal complications that are related to neurodevelopmental impairment, 7- technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: 2. It is a cost-effective strategy. 3. It improves neonatal outcome (in premature newborns < 30 weeks), and reduces infectious maternal morbidity. 4. It improves neurodevelopmental outcome at 1, 2 and 5 years.;Primary end point(s): 1- Number of antenatal steroid dosed administered. 2- Maternal hospital length stay (days).;Timepoint(s) of evaluation of this end point: We planned duration of the study around 2 years for objectives 1-3 and 7 years for objective 4.	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection: 2. It is a cost-effective strategy. 3. It improves neonatal outcome (in premature newborns < 30 weeks), and reduces infectious maternal morbidity. 4. It improves neurodevelopmental outcome at 1, 2 and 5 years.;Primary end point(s): 1- Number of antenatal steroid dosed administered. 2- Maternal hospital length stay (days).;Timepoint(s) of evaluation of this end point: We planned duration of the study around 2 years for objectives 1-3 and 7 years for objective 4.

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Secondary

Measure	Time frame
Secondary end point(s): 3- Gestational age at delivery. 4- Spontaneous delivery within 7 days from admission (yes/no), defined as the latency from admission to delivery less or equal to 7 days. 5- Intra-amniotic infection (yes/no), defined as the presence of microorganisms in the amniotic fluid identified using aerobic/anaerobic/genital mycoplasma cultures or 16S rRNA gene sequencing. 6- Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need of transfusion, maternal death. 7- Neonatal stay length duration (days). 8- Neonatal anthropometric data: birthweight, height, cephalic, thoracic and abdominal perimeters, arm circumference 9- Major neonatal outcome (yes/no) defined as the presence or one or more of the following outcomes: fetal or neonatal dead, early onset sepsis, moderate/severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, periventricular leukomalacia, surgical necrotising enterocolitis, retinopathy that needs laser. 10- Neurodevelopmental impairment (yes/no) and definition of the domains involved: communication, fine motor, gross motor, problem solving and personal-social. 11- Cost analysis: costs were calculated as the product of resource use and unit costs. Resource use during the study period was documented. The following resource items were collected: maternal and neonatal admissions, method of delivery, type of induction, outpatient visits, medication, maternal laboratory tests, neonatal monitoring. Maternal admissions were differentiated into three levels of care (intensive, medium, ward). Neonatal admissions were divided into four levels of care (intensive, high, medium ward). Ward admissions of newborns were not calculated; these costs were already incorporated in costs of maternal ward admissions. Use of the labor room was calculated as hours between admission to labor room and birth plus 1 h extra for extended recovery care.;	—

Measure

Time frame

Secondary end point(s): 3- Gestational age at delivery. 4- Spontaneous delivery within 7 days from admission (yes/no), defined as the latency from admission to delivery less or equal to 7 days. 5- Intra-amniotic infection (yes/no), defined as the presence of microorganisms in the amniotic fluid identified using aerobic/anaerobic/genital mycoplasma cultures or 16S rRNA gene sequencing. 6- Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need of transfusion, maternal death. 7- Neonatal stay length duration (days). 8- Neonatal anthropometric data: birthweight, height, cephalic, thoracic and abdominal perimeters, arm circumference 9- Major neonatal outcome (yes/no) defined as the presence or one or more of the following outcomes: fetal or neonatal dead, early onset sepsis, moderate/severe bronchopulmonary dysplasia, severe intraventricular haemorrhage, periventricular leukomalacia, surgical necrotising enterocolitis, retinopathy that needs laser. 10- Neurodevelopmental impairment (yes/no) and definition of the domains involved: communication, fine motor, gross motor, problem solving and personal-social. 11- Cost analysis: costs were calculated as the product of resource use and unit costs. Resource use during the study period was documented. The following resource items were collected: maternal and neonatal admissions, method of delivery, type of induction, outpatient visits, medication, maternal laboratory tests, neonatal monitoring. Maternal admissions were differentiated into three levels of care (intensive, medium, ward). Neonatal admissions were divided into four levels of care (intensive, high, medium ward). Ward admissions of newborns were not calculated; these costs were already incorporated in costs of maternal ward admissions. Use of the labor room was calculated as hours between admission to labor room and birth plus 1 h extra for extended recovery care.;

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Countries

Spain

Contacts

Public Contactmpalacio

Fundació de Recerca Clínic Barcelona_ Institut d'Investigacions Biomèdiques Augustí Pi i Sunyer Barcelona

mpalacio@clinic.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026