Chronic Pancreatitis, Genetic Mutation, Pregnancy Related
Conditions
Brief summary
To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.
Detailed description
The goal of this observational study is to explore the impact of CP susceptibility genes (SPINK1, PRSS1, CTRC, CFTR) on pregnancy outcomes (including both maternal and fetal outcomes) in a large Chinese cohort. Participants will be asked to provide their pregnancy-related data.
Interventions
DIAGNOSTIC_TESTgenetic sequencing
sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.
Sponsors
Changhai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* female patients with a diagnosis of chronic pancreatitis * have known genetic backgrounds and pregnancy history * agree to join the study and provide informed consent
Exclusion criteria
* patients without documented pregnancy * patients who denied to provide pregnancy-related information, or with incomplete pregnancy characteristics and/or outcomes * patients with other autoimmune comorbidities that might influence pregnancy outcomes, such as systemic lupus erythematosus, autoimmune thyroid diseases, etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse maternal outcomes of female CP patients | through study completion, an average of 1 year | * CP-associated caesarean delivery referred to caesarean deliveries which happened due to the attack of CP or comorbidities associated with CP such as GDM and HDP. * CP-associated preterm delivery was defined as preterm deliveries which happened due to the attack of CP or comorbidities associated with CP. * GDM was defined as the onset or first recognition of abnormal glucose tolerance during pregnancy. * Intrahepatic cholestasis of pregnancy was based on characteristic symptoms, as well as elevated serum bile acids, in the absence of other hepatobiliary disease. * HDP included preeclampsia/eclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, and gestational hypertension. |
| adverse fetal outcomes of female CP patients | through study completion, an average of 1 year | * Low birth weight was defined as weight at birth \<2500 g. * CP-associated abortion referred to abortions (i.e., a nonviable intrauterine pregnancy up to 20 weeks' gestation) which happened due to the attack of CP or comorbidities associated with CP. * Congenital anomaly referred to the inborn errors of development. * Stillbirth was defined as the delivery of a fetus ≥20 weeks of gestation with no signs of life. |
Countries
China
Outcome results
None listed