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Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05591599
Acronym
CNN2
Enrollment
407
Registered
2022-10-24
Start date
2022-12-05
Completion date
2025-01-31
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tubal Pregnancy

Keywords

CALPONIN 2, CNN2, ectopic pregnancy, tubal pregnancy

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.

Interventions

DIAGNOSTIC_TESTcalponin 2

serum calponin 2 level

Sponsors

Mỹ Đức Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

Case: tubal pregnancy * Inclusion criteria * Patients aged 18 years to \< 35 years old * Positive beta-hCG result * Diagnosed with tubal pregnancy based on pathological result. *

Exclusion criteria

* BMI \> 30 kg/m2 * A co-existing additional pregnancy * Refuse to participate in the study Control group: 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 early pregnancy loss or viable intrauterine pregnancy. Early pregnancy loss * Inclusion criteria * Patients aged 18 years old to \< 35 years old * Positive beta-hCG result * Pregnancy outcome recorded as early pregnancy loss: ultrasound shows an empty gestational sac in the uterus or a gestational sac with embryos but no fetal cardiac activity within the first 12 weeks 6/7 days of pregnancy. Or there is pathological pathology of the specimen taken from the uterine lumen as placenta or fetal tissue. *

Design outcomes

Primary

MeasureTime frameDescription
The average serum CNN2 levelUp to 12 6/7 weeks of gestational ageThe average serum CNN2 level of each group

Secondary

MeasureTime frameDescription
The average beta hCG levelUp to 12 6/7 weeks of gestational ageThe average beta hCG level of each group

Countries

Vietnam

Contacts

Primary ContactMinh N Chau, MD
bsminh.cn@myduchospital.vn903119996
Backup ContactTrung T Ly, MD
bstrung.lt@myduchospital.vn901558786

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026