Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922580
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2021-06-05
Brief Title:
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Organization:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Overview
Official Title:
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of PregnancyICPSerum total bile acid level exceeding 40 µmolL has been associated with increased risk of meconium staining low Apgar scores preterm delivery and stillbirthOther predictors such as level of transaminases history of cholelithiasis and hepatitis virus infection have been studied but the results are inconclusiveA more comprehensive investigation involving multiple neonatal outcomes and a wide variety of outcome predictors is needed in order to establish guidelines for optimal timing of delivery in pregnancies complicated by ICP The aim of our study was to evaluate wide variety of predictors of adverse neonatal outcomes in a large cohort of women with ICP
Detailed Description:
We performed a retrospective cohort study of all women diagnosed with ICP Pregnancy outcomes including delivery gestational age spontaneous preterm delivery iatrogenic preterm delivery birth weight mode of delivery oligohydramnios intrauterine growth restriction IUGR placental abruption preterm premature rupture of membrane PPROM concerning fetal heart tracing chorioamnionitis endometritis postpartum hemorrhage transfusion stillbirth neonatal intensive care unit NICU admission hyperbilirubinemia meconium stained amniotic fluid respiratory distress syndromeRDS or transient tachypnea of newbornTTN transient tachypnea of the newborn and composite neonatal outcome were ascertained A composite adverse neonatal outcome was created and defined as any of the following NICU admission hypoglycemia hyperbilirubinemia RDS TTN mechanical ventilation use oxygen by nasal cannula pneumonia and stillbirth PPROM was defined by rupture of membrane before 37 weeks gestation Concerning fetal heart tracing was defined as recurrent variable or late decelerations with moderate variability prolonged decelerations or category 3 tracing Providers who were caring for the women reviewed and independently characterized fetal heart tracings Since fetal heart tracings were not accessible to authors authors accepted the providers interpretation For analysis of concerning fetal heart tracing women with non-labor cesarean section were excluded Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion Diagnosis of RDS and TTN were made by the managing neonatologist and based on standard clinical guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None