Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Completed

• Conditions: Intrahepatic Cholestasis

• Registration Number: NCT01381939
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2006-12
• Status Verified: 2010-03
• Study Completion: 2010-04
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Last Update Submitted: 2011-06-24
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cesarean section	32 to 40 weeks

Secondary Outcome Measures

Name	Time	Method
Bleeding	32 to 40 weeks
Abruptio placentae	32 to 40 weeks
APGAR	32 to 40 weeks