Genetic Factors and CP Pregnancy Outcomes

NCT06055595 | Unknown DMC

• 1 other identifier: CP-gene-pregnancy outcomes
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the impact of chronic pancreatitis (CP) susceptibility genes on pregnancy outcomes.

Conditions

Chronic Pancreatitis; Genetic Mutation; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• adverse maternal outcomes of female CP patients

  * 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.

  through study completion, an average of 1 year

• adverse fetal outcomes of female CP patients

  * 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.

  through study completion, an average of 1 year

Interventions

genetic sequencing DIAGNOSTIC_TEST

sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There were 292 female patients diagnosed with CP and underwent genetic testing from January 2010 to December 2014 in this cohort. After application of exclusion criteria, a total of 160 patients who had known genetic backgrounds and pregnancy history were enrolled in this study.

You may qualify if:

• female patients with a diagnosis of chronic pancreatitis
• have known genetic backgrounds and pregnancy history
• agree to join the study and provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• Wu D, Ru N, Wang YC, Ma GX, Shi TY, Xiong SH, You AJ, Wang L, Hu LH, Li ZS, Zou WB, Liao Z. Genetic Factors Associated With Adverse Pregnancy Outcomes in Chronic Pancreatitis. Clin Transl Gastroenterol. 2024 Apr 1;15(4):e00691. doi: 10.14309/ctg.0000000000000691.

  PMID: 38334943 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The remained peripheral blood sample after laboratory examinations.

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2010
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)