Induction of Labor in Intrahepatic Cholestasis of Pregnancy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01381939

Acronym

ILICP

Enrollment

5000

Registered

2011-06-27

Start date

2000-01-31

Completion date

2010-04-30

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholestasis

Keywords

Intrahepatic Cholestasis of Pregnancy, Induction of labor, Pregnancy, Caesarian section, Pruritus, IUFD

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cesarean section	32 to 40 weeks

Secondary

Measure	Time frame
Bleeding	32 to 40 weeks
Abruptio placentae	32 to 40 weeks
APGAR	32 to 40 weeks

Outcome results