Genetic Factors and CP Pregnancy Outcomes

Pregnancy Related Clinical Trial

Official title:

The Impact of Genetic Factors on Pregnancy Outcomes in Chronic Pancreatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06055595
• Other study ID #: CP-gene-pregnancy outcomes
• Status: Active, not recruiting
• Start date: January 2010
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Genetic Mutation
• Pancreatitis
• Pancreatitis, Chronic
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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