Intrahepatic cholestasis of pregnancy Pregnancy and Childbirth Liver disorders in pregnancy, childbirth and the puerperium
Conditions
Interventions
Pregnant women are evaluated. The cases are divided into two groups: group 1, in which the pregnancy is complicated by ICP, and group 2 which covers the women without ICP.
The study involves a conver
Sponsors
Nicolae Testemi?anu State University of Medicine and Pharmacy
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. ICP (pruritus with a raised serum bile acid above 10 µmol/l) for the main group 2. Absence of ICP (absence of pruritus and normal serum bile acid (below 10 µmol/l)) for the control group 3. At least 22+0 weeks of gestation on day of recruitment 4. No known lethal fetal anomaly 5. Aged 18 years or over 6. Able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Women with known liver disease: acute viral hepatitis, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis, primary biliary cirrhosis, symptomatic cholelithiasis, cytomegalovirus, Epstein-Barr virus, acute fatty liver of the pregnancy, drug-induced hepatitis 2. Women diagnosed with preeclampsia, HELLP syndrome and congenital thrombophilia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of perinatal morbidity and mortality, preterm delivery or neonatal admission for at least 4 hours; measured from patient medical notes between randomisation and 7 days post-delivery (death), or to discharge (neonatal unit admission) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peak maternal serum concentration (between recruitment and delivery) of the following biochemical indices of disease: 1.1. Bile acids measured using blood test 1.2. Aspartate transaminase measured using blood test 1.3 Alanine transaminase measured using blood test 2. Vitamin K serum level measured using blood test 3. Prothrombin, fibrinogen, INR serum levels measured using blood test 4. Change of itch between recruitment and delivery, measured by the worst episode of itch over past 24 hours (mm on visual analogue scale, assessed at clinic visits) 5. Mode of delivery classified as spontaneous vaginal, instrumental vaginal or caesarean 6. In utero fetal death after recruitment 7. Preterm delivery – less than 37 weeks’ gestation 8. Known neonatal death up to 7 days 9. Birth weight (g) 10. Newborn assessed using Apgar Score at 1 and 5 minutes postpartum 11. Gestational age at delivery 12. Estimate maternal blood loss at delivery Measured from patient medical notes where not otherwise stated at the clinic visits and during admission for delivery up to the discharge of mother and infant | — |
Countries
Moldova
Contacts
Public ContactMaria Cemortan
Outcome results
None listed