Preterm Birth, Preterm Labor, Intra-amniotic Infection, Amniocentesis Affecting Fetus or Newborn
Conditions
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: 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.
Interventions
DRUGSteroid Drug
Steroids doses will be optimized in the intervention group according the risk based on predictive models
DRUGTocolytic Agents
Tocolysis duration will be optimized in the intervention group according the risk based on predictive models
Sponsors
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
Complexo Hospitalario Universitario de A Coruña
Hospital Son Llatzer
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitario de Torrejón
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antenatal steroid doses | through study completion, an average of 1 year | Number of antenatal steroid doses administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maternal stay length | through study completion, an average of 1 year | Maternal length of hospital stay (in days). |
| Clinical chorioamnionitis | through study completion, an average of 1 year | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbial invasion of amniotic cavity | through study completion, an average of 1 year | 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 |
| Cost analyses | through study completion, an average of 1 year | 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. |
| Maternal morbidity | through study completion, an average of 1 year | Maternal morbidity (yes/no) including intrapartum fever, endometritis, infection of surgical wound, sepsis, curettage, admission to ICU, hysterectomy, need for transfusion, maternal death. |
| Neonatal length of hospital stay | through study completion, an average of 1 year | Neonatal length of hospital stay (days) |
| Tocolysis duration | through study completion, an average of 1 year | Tocolysis duration (in days) |
| height (in centimeters) | through study completion, an average of 1 year | Neonatal anthropometric measurements |
| cephalic, thoracic and abdominal perimeters (in millimeters) | through study completion, an average of 1 year | Neonatal anthropometric measurements |
| arm circumference (in centimeters) | through study completion, an average of 1 year | Neonatal anthropometric measurements |
| Adverse neonatal outcome | through study completion, an average of 1 year | 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. |
| Neonatal birthweight (in grams) | through study completion, an average of 1 year | Neonatal anthropometric measurements |
| Gestational age at delivery | through study completion, an average of 1 year | Gestational age at delivery |
| Spontaneous delivery within 7 days after admission | through study completion, an average of 1 year | Spontaneous delivery within 7 days after admission (yes/no), |
Countries
Spain
Outcome results
None listed