Intrahepatic CholestasisILICPNCT01381939
Induction of Labor in Intrahepatic Cholestasis of Pregnancy
An observational study of Intrahepatic Cholestasis, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intrahepatic Cholestasis
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Swedish women affected by ICP delivering at Danderyd Hospital between year 2000-2006.
Who may be able to join
- ICP during pregnancy and induction of labor ICP and spontaneous delivery No ICP but induction of labor
Who cannot join
- No ICP spontaneous delivery
- Elective caesarian section
About this study
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.
- Conditions
- Intrahepatic Cholestasis
- Keywords
- Intrahepatic Cholestasis of Pregnancy, Induction of labor, Pregnancy, Caesarian section, Pruritus, IUFD
- Medical subject headings
- Cholestasis, Intrahepatic, Intrahepatic Cholestasis of Pregnancy, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section
Measured: 32 to 40 weeks
Secondary outcomes (3)
Bleeding
Measured: 32 to 40 weeks
Abruptio placentae
Measured: 32 to 40 weeks
APGAR
Measured: 32 to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2000
- Primary completionDec 2006
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholestasisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381939
- Sponsor's protocol ID
- 6647416
- Acronym
- ILICP
- Status last verified
- Mar 2010
- First submitted
- 23 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labor in Intrahepatic Cholestasis of Pregnancy
- ClinicalTrials.gov ID
- NCT01381939
- Acronym / sponsor ID
- ILICP / 6647416
- Conditions
- Intrahepatic Cholestasis
- Keywords
- Intrahepatic Cholestasis of Pregnancy, Induction of labor, Pregnancy, Caesarian section, Pruritus, IUFD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Swedish women affected by ICP delivering at Danderyd Hospital between year 2000-2006.
Key inclusion criteria (1 listed)
- ICP during pregnancy and induction of labor ICP and spontaneous delivery No ICP but induction of labor
Key exclusion criteria (2 listed)
- No ICP spontaneous delivery
- Elective caesarian section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cesarean section
Time frame: 32 to 40 weeks
3 secondary outcomes
Bleeding
Time frame: 32 to 40 weeks
Abruptio placentae
Time frame: 32 to 40 weeks
APGAR
Time frame: 32 to 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
Related trials for Intrahepatic Cholestasis
Active, not recruitingPhase 3
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cirrhosis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholestasis, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section (time frame: 32 to 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.