Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Induction of Labour in Intrahepatic Cholestasis of Pregnancy (ICP) has become a common procedure in management of ICP to avoid fetal complications. Surprisingly, this empirical approach has not been evaluated as to delivery complications and fetal outcome as yet. The investigators now examine weather ICP affects (i) delivery procedures chosen, in particular the incidence of caesarian section, (ii)fetal and maternal outcome in induced labor, and (iii)possible impact of bile acids and UDCA treatment in a retrospective cohort study based on approximately 5000 induced deliveries at Danderyd Hospital, Karolinska Institutet, Stockholm. The investigators analyze data on on previous deliveries, BMI, medical history and medical book data. Primary endpoint is the risk of caesarian section.

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Key information

Conditions

Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Intrahepatic Cholestasis of Pregnancy Liver Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ICP during pregnancy and induction of labor ICP and spontaneous delivery No ICP but induction of labor

Exclusion criteria

No ICP spontaneous delivery
Elective caesarian section

Treatment and study plan

Primary outcomes

Cesarean section

Time frame: 32 to 40 weeks

Secondary outcomes

Bleeding

Time frame: 32 to 40 weeks
Abruptio placentae

Time frame: 32 to 40 weeks
APGAR

Time frame: 32 to 40 weeks

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: ILICP

Important dates

Study start: 2000
Primary completion: 2006
Study completion: 2010
First posted: Jun 27, 2011
Registry last updated: Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed