To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis (NCT04831086) | Clinical Trial Compass
CompletedPhase 3
To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis
Spain247 participantsStarted 2021-05-05
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
Antenatal steroid doses
Timeframe: through study completion, an average of 1 year