Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy

NCT04922580 | Completed

• 1 other identifier: ICP
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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 .

Conditions

Intrahepatic Cholestasis of Pregnancy

Outcome Measures

Primary Outcomes (9)

• Hypoglycemia

  Hypoglycemia was defined by neonatal hypoglycemia that required intravenous infusion

  up to 28 days

• Hyperbilirubinemia

  Hyperbilirubinemia was defined by neonatal hyperbilirubinemia that required phototherapy

  up to 28 days

• NICU admission

  Newborns required hospitalization in the NICU after birth

  up to 28 days

• RDS

  Newborns were diagnosed with respiratory distress syndrome

  up to 28 days

• TTN

  Newborns were diagnosed with transient tachypnea of the newborn

  up to 28 days

• mechanical ventilation use

  Newborns required mechanical ventilation

  up to 28 days

• oxygen by nasal cannula

  Newborns required oxygen by nasal cannula

  up to 28 days

• pneumonia

  Newborns were diagnosed with pneumonia

  up to 28 days

• stillbirth

  newborns died after birth

  up to 1 day

Study Arms (2)

Hospitalization group

Newborns of ICP mothers require hospitalization after birth

without Hospitalization group

Newborns of ICP mothers don't require hospitalization after birth

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

neonates

You may qualify if:

• 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.

You may not qualify if:

• The newborns were born with severe congenital heart disease and deformities

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• maternal and child health hospital of Yong Chuan District: collaborator

Study Sites (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 10, 2021
• Study Start: January 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

CN (1)