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Induction of Labor in Intrahepatic Cholestasis of Pregnancy (ILICP)

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01381939
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: March 2010
History of Changes
  Purpose

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.


Condition
Intrahepatic Cholestasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Cesarean section [ Time Frame: 32 to 40 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding [ Time Frame: 32 to 40 weeks ] [ Designated as safety issue: No ]
  • Abruptio placentae [ Time Frame: 32 to 40 weeks ] [ Designated as safety issue: No ]
  • APGAR [ Time Frame: 32 to 40 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: January 2000
Study Completion Date: April 2010
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Induction of labor in ICP
Induction of laborin women with ICP
Induction of labor in women with no ICP
No ICP
ICP and spontanius delivery

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Swedish women affected by ICP delivering at Danderyd Hospital between year 2000-2006.

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof Hanns-Ulrich Marschall, Sahlgrenska Academy, University of Gothenburg
ClinicalTrials.gov Identifier: NCT01381939     History of Changes
Other Study ID Numbers: 6647416
Study First Received: June 23, 2011
Last Updated: June 24, 2011
Health Authority: The National Board of Health and Welfare: Sweden

Keywords provided by Karolinska Institutet:
Intrahepatic Cholestasis of Pregnancy
Induction of labor
Pregnancy
 Caesarian section
Pruritus
IUFD

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
 Biliary Tract Diseases
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013