Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy

Completed

• Conditions: Intrahepatic Cholestasis of Pregnancy

• Registration Number: NCT04922580
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of meconium staining, low Apgar scores, preterm delivery, and stillbirth.Other predictors such as level of transaminases, history of cholelithiasis, and hepatitis virus infection have been studied but the results are inconclusive.A 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 syndrome(RDS) or transient tachypnea of newborn(TTN) (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 Timeline

• Study Start: 2012-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2021-06-05
• Study First Submitted QC: 2021-06-05
• Study First Posted: 2021-06-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Newborns were born in maternal and child health hospital of Yong Chuan District from January 2012 to December 2020;②all Newborns' mothers diagnosed intrahepatic cholestasis of pregnancy.

Exclusion Criteria

The newborns were born with severe congenital heart disease and deformities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stillbirth	up to 1 day	newborns died after birth
NICU admission	up to 28 days	Newborns required hospitalization in the NICU after birth
Hypoglycemia	up to 28 days	Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion
Hyperbilirubinemia	up to 28 days	Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy
oxygen by nasal cannula	up to 28 days	Newborns required oxygen by nasal cannula
RDS	up to 28 days	Newborns were diagnosed with respiratory distress syndrome
pneumonia	up to 28 days	Newborns were diagnosed with pneumonia
TTN	up to 28 days	Newborns were diagnosed with transient tachypnea of the newborn
mechanical ventilation use	up to 28 days	Newborns required mechanical ventilation

Trial Locations

Locations (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China