In this study we will investigate the management of HCA during pregnancy based on a prospectively acquired online database in the Netherlands.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
*To investigate the proportion of patients in which HCA growth during pregnancy
occurs
Secondary outcome
*To investigate in which trimester of pregnancy growth of HCA occurs;
*To investigate the degree of growth of HCA during pregnancy;
*To investigate whether there is regression of HCA postpartum;
*To investigate the HCA-related interventions during pregnancy;
*To investigate the incidence of bleeding of HCA during pregnancy;
*To investigate liver-related clinical signs during pregnancy;
*To investigate elevated liver enzymes during pregnancy;
*To evaluate the quality of life of pregnant patients with HCA;
*To investigate whether there is a difference between quality of life of
pregnant patients with HCA and pregnant patients with other comorbidity that
have an indication for pregnancy care at the obstetrician in secondary care and
healthy pregnant patients.
Background summary
Hepatocellular adenoma (HCA) in pregnant women requires special considerations
because of the risk of hormone induced growth and spontaneous rupture, due to
increased levels of steroid hormones during pregnancy that may threaten the
life of both mother and child. Most experts advocate that women with HCA should
not get pregnant or advise surgical resection before pregnancy. We recently
proposed not to discourage all women with HCA from pregnancy, based on a study
in which we monitored twelve women with documented HCA during a total of 17
pregnancies. In 4 cases HCA*s grew during pregnancy, requiring a Caesarean
section in 1 patient (2 pregnancies) and radiofrequency ablation in 1 case
during the first trimester of pregnancy. All pregnancies had an uneventful
course with a successful maternal and fetal outcome. However, there is no
evidence-based algorithm for the evaluation and management of HCA during
pregnancy, due to scarcity of cases. The conclusion not to discourage all women
with HCA from pregnancy has, however, to be proven in a large multicentre study
in which we will closely monitor pregnant patient with a HCA in a prospectively
acquired database to give more insight in the behaviour of HCA during
pregnancy.
Study objective
In this study we will investigate the management of HCA during pregnancy based
on a prospectively acquired online database in the Netherlands.
Study design
In this study we will investigate the management of HCA during pregnancy based
on a prospectively acquired online database in the Netherlands. The PALM-study
is a multi-centre prospective case-control study.
Study group
Properly Dutch speaking, pregnant patients, 18 years of age or older with a
radiologically (MRI with liver specific contrast agent) and/or histologically
proven diagnosis of HCA can be included in the study. Radiological diagnosis of
HCA will be based on contrast enhanced magnetic resonance imaging (pre- or
postpartum). Lesions must not exceed 5 cm. These patients have an indication
for pregnancy care at obstetrician in secondary care.
In the first weeks of pregnancy patients will be referred to the obstetrician
for pregnancy care. Baseline starts at 14 (+/- 3) weeks of gestation. At this
day and every 6 weeks patients will undergo ultrasound (US) of the HCA lesion
at the hepatologist and patients will, if possible, undergo a venapunction at
14 and 32 weeks of pregnancy. Before US of the HCA lesions and 2 days
afterwards patients will be asked to fill out the Shortform 36 (SF-36)
questionnaire.
Study burden and risks
Patients will experience minimal impact of this study, without additional
risks. The study takes time from the patient.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Study groep: Properly Dutch speaking, pregnant patients, 18 years of age or older with a radiologically and/or histologically proven diagnosis of hepatocellular adenoma can be included in the study. Radiological diagnosis of HCA will be based on contrast enhanced magnetic resonance imaging (pre- or postpartum). Lesions must not exceed 5 cm. Informed consent must be signed.
Exclusion criteria
Dementia or impaired mental function that would counter the understanding of giving informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL36058.078.11 |