Induction of Labor in Intrahepatic Cholestasis of Pregnancy

NCT ID: NCT01381939

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Intrahepatic Cholestasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Induction of labor in ICP

Induction of laborin women with ICP

No interventions assigned to this group

Induction of labor in women with no ICP

No ICP

No interventions assigned to this group

ICP and spontanius delivery

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Sahlgrenska Academy, University of Gothenburg

Other Identifiers

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6647416

Identifier Type: -

Identifier Source: org_study_id

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