NCT05591599

Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 407 (estimated)
• Sponsor: Mỹ Đức Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Ectopic pregnancy (EP) is the implantation of a fertilized egg outside the main cavity of the uterus. EP is one of the most common gynecologic surgical emergencies , and one of leading causes of maternal mortality in the first trimester of pregnancy. Embryo implantation exerts different pressure on uterine and tubal epithelial and smooth muscle cells, calponin 2 (CNN2) expression at the implantation site would differ between intrauterine pregnancy and tubal pregnancy. The investigators conduct this study to find out the diagnostic value of CNN2 in identifying tubal pregnancies.

Detailed description

This is a case-control prospective study. Women age 18-35 years old, come to My Duc, My Duc phu Nhuan Hospital and Ngoc Lan Clinic and have the indication of testing beta human chorionic gonadotropin (hCG) for determining pregnancy status because of 1-14 days period delay with or without abdominal pain, vaginal bleeding or after assisted reproductive technology. Those women will be introduced about the study. If they agree to take part in and write the consent form, they will be taken 5ml of blood more at the same time of testing beta hCG. Blood sample will then be centrifuged and collected serum will then be stored at -80 celsius degree. Women with negative beta hCG will be excluded. Women with positive beta hCG will be followed-up pregnancy as routine until 12 6/7 weeks of gestational age (GA). At this time, those women will be screened using including and excluding criteria for each group. They then be put group into (1) tubal pregnancy, (2) viable pregnancy and (3) early pregnancy loss. Stored serum sample will be defrosted and measured CNN2 concentration.

Conditions

• Tubal Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	calponin 2	serum calponin 2 level

Timeline

• Start date: 2022-12-05
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2022-10-24
• Last updated: 2023-03-16

Locations

1 site across 1 country: Vietnam