Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy

Intrahepatic Cholestasis of Pregnancy Clinical Trial

Official title:

Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922580
• Other study ID #: ICP
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

The newborns were born with severe congenital heart disease and deformities

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Intrahepatic
• Intrahepatic Cholestasis of Pregnancy
• Pregnancy Complications

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	maternal and child health hospital of Yong Chuan District

Country where clinical trial is conducted

China, 

Outcome

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