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CompletedNCT01381939ILICPUpdated Jun 27, 2011

Induction of Labor in Intrahepatic Cholestasis of Pregnancy

An observational study in Intrahepatic Cholestasis, sponsored by Karolinska Institutet. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2011-06-27.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,000
Sex
Female
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Study 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.

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Conditions studied

  • Intrahepatic Cholestasis

Keywords

  • Intrahepatic Cholestasis of Pregnancy
  • Induction of labor
  • Pregnancy
  • Caesarian section
  • Pruritus
  • IUFD
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In context

Cholestasis

220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 100 across 65 observational studies indexed under Cholestasis.

Browse Cholestasis studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No ICP spontaneous delivery
  • Elective caesarian section
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,000 participants (estimated)

Groups and 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
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What researchers measure

Primary outcomes

  1. Cesarean section

    Time frame: 32 to 40 weeks

Secondary outcomes

  1. Bleeding

    Time frame: 32 to 40 weeks

  2. Abruptio placentae

    Time frame: 32 to 40 weeks

  3. APGAR

    Time frame: 32 to 40 weeks

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01381939
Lead sponsor
Karolinska Institutet
First posted
Jun 27, 2011
Start date
Jan 2000
Primary completion
Dec 2006
Completion
Apr 2010
Last update
Jun 27, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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