Genetic Factors and CP Pregnancy Outcomes

Sponsor
Changhai Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06055595
Collaborator
(none)
160
1
180
0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: genetic sequencing

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of Genetic Factors on Pregnancy Outcomes in Chronic Pancreatitis
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhai Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Principal Investigator: Zhuan Liao, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT06055595
Other Study ID Numbers:
  • CP-gene-pregnancy outcomes
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023