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| Name | Class |
|---|---|
| Hospital Vall d'Hebron | OTHER |
| Hospital Universitario La Fe | OTHER |
| Hospital Universitario La Paz | OTHER |
| Hospital Universitario 12 de Octubre |
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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
To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid Drug | Drug | Steroids doses will be optimized in the intervention group according the risk based on predictive models |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antenatal steroid doses | Number of antenatal steroid doses administered | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| maternal stay length | Maternal length of hospital stay (in days). | through study completion, an average of 1 year |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tocolysis duration | Tocolysis duration (in days) | through study completion, an average of 1 year |
| Gestational age at delivery | Gestational age at delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Cobo, MD, PhD | Fundació Recerca Biomèdica Clínica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Recerca Biomèdica Clínica | Barcelona | 08828 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32147290 | Result | 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. | |
| 34588268 |
| Label | URL |
|---|---|
| Predictive models of spontaneous delivery within 7 days and of intra-amniotic infections description | View source |
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all collected IPD
Data will be available after the end of the study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2021 | Mar 31, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015149 | Tocolytic Agents |
| ID | Term |
|---|---|
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| OTHER |
| Consorci Sanitari de Terrassa | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
| Hospital Universitario Puerta del Mar | OTHER |
| Hospital Sant Joan de Deu | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
| Hospital Clínico Universitario Lozano Blesa | OTHER |
| Parc Taulí Hospital Universitari | OTHER |
| Complexo Hospitalario Universitario de A Coruña | OTHER |
| Hospital Son Llatzer | OTHER |
| Hospital Universitari Joan XXIII de Tarragona. | OTHER |
| Hospital Universitario de Torrejón | UNKNOWN |
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.
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| Tocolytic Agents | Drug | Tocolysis duration will be optimized in the intervention group according the risk based on predictive models |
|
| through study completion, an average of 1 year |
| through study completion, an average of 1 year |
| Spontaneous delivery within 7 days after admission | Spontaneous delivery within 7 days after admission (yes/no), | through study completion, an average of 1 year |
| 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 |
| 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 |
| 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 |
| Neonatal length of hospital stay | Neonatal length of hospital stay (days) | through study completion, an average of 1 year |
| Neonatal birthweight (in grams) | Neonatal anthropometric measurements | through study completion, an average of 1 year |
| height (in centimeters) | Neonatal anthropometric measurements | through study completion, an average of 1 year |
| cephalic, thoracic and abdominal perimeters (in millimeters) | Neonatal anthropometric measurements | through study completion, an average of 1 year |
| arm circumference (in centimeters) | Neonatal anthropometric measurements | through study completion, an average of 1 year |
| 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 |
| Derived |
| 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. |
| D045506 | Therapeutic Uses |