Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies (CNN2)

March 15, 2023 updated by: Mỹ Đức Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

407

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • My Duc Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged 18 to <35 years old, coming to the clinic because their period is 1-14 days delay with or without abdominal pain, vaginal bleeding, or women at this age come to the clinic for follow-up after assisted reproductive technology at Ngoc Lan clinic, My Duc hospital, My Duc Phu Nhuan; and had a positive beta-hCG result.

Description

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.

  • Exclusion criteria

    • BMI > 30 kg/m2
    • A co-existing ectopic pregnancy
    • Refuse to participate in the study

Viable intrauterine pregnancy

  • Inclusion criteria

    • Patients aged 18 years old to < 35 years old
    • Transvaginal ultrasound records images of a living fetus in the uterine with embryos and fetal heart activity until 12 6/7 weeks of gestation (ultrasound or last menstrual period)

  • Exclusion criteria

    • BMI > 30 kg/m2
    • A co-existing ectopic pregnancy
    • Multiple pregnancies
    • Refuse to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
Women diagnosed with tubal pregnancy
Diagnostic test: calponin 2
serum calponin 2 level
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 spontaneous abortion or viable intrauterine pregnancy
Diagnostic test: calponin 2
serum calponin 2 level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average serum CNN2 level
Time Frame: Up to 12 6/7 weeks of gestational age
The average serum CNN2 level of each group
Up to 12 6/7 weeks of gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average beta hCG level
Time Frame: Up to 12 6/7 weeks of gestational age
The average beta hCG level of each group
Up to 12 6/7 weeks of gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mỹ Đức Hospital

Investigators

  • Principal Investigator: Minh N Chau, MD, Mỹ Đức Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/22/DD-BVMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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