Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

Recruiting

• Conditions: Tubal Pregnancy
• Interventions: Diagnostic Test: calponin 2

• Registration Number: NCT05591599
• Lead Sponsor: Mỹ Đức Hospital

Brief 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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-24
• Study Start: 2022-12-05
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 407

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	calponin 2	Women diagnosed with tubal pregnancy
Control group	calponin 2	Women with the age corresponding to the case group (matched with the same age or +/- 2 years difference compared with the case group), diagnosed with spontaneous abortion or viable intrauterine pregnancy

Primary Outcome Measures

Name	Time	Method
The average serum CNN2 level	Up to 12 6/7 weeks of gestational age	The average serum CNN2 level of each group

Secondary Outcome Measures

Name	Time	Method
The average beta hCG level	Up to 12 6/7 weeks of gestational age	The average beta hCG level of each group

Trial Locations

Locations (1)

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Vietnam