Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Intrahepatic Cholestasis Clinical Trial

— ILICP  

Official title:

Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381939
• Other study ID #: 6647416
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: June 24, 2011
• Start date: January 2000
• Est. completion date: April 2010

Study information

• Verified date: March 2010
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: The National Board of Health and Welfare: Sweden
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: April 2010
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean section		32 to 40 weeks	No
Secondary	Bleeding		32 to 40 weeks	No
Secondary	Abruptio placentae		32 to 40 weeks	No
Secondary	APGAR		32 to 40 weeks	No