NCT01381939

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

June 27, 2011

Status Verified

March 1, 2010

Enrollment Period

6.9 years

First QC Date

June 23, 2011

Last Update Submit

June 24, 2011

Conditions

Intrahepatic Cholestasis

Keywords

Intrahepatic Cholestasis of PregnancyInduction of laborPregnancyCaesarian sectionPruritusIUFD

Outcome Measures

Primary Outcomes (1)

  • Cesarean section

    32 to 40 weeks

Secondary Outcomes (3)

  • Bleeding

    32 to 40 weeks

  • Abruptio placentae

    32 to 40 weeks

  • APGAR

    32 to 40 weeks

Study Arms (3)

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 Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No ICP spontaneous delivery
  • Elective caesarian section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholestasis, IntrahepaticIntrahepatic Cholestasis of PregnancyPruritus

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

January 1, 2000

Primary Completion

December 1, 2006

Study Completion

April 1, 2010

Last Updated

June 27, 2011

Record last verified: 2010-03