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Tubal PregnancyCNN2NCT05591599

Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

An observational study of Tubal Pregnancy, run by Mỹ Đức Hospital at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Tubal Pregnancy
What is being tested?
calponin 2
How many people
407 participants
Where
1 siteVietnam
Study dates
5 Dec 2022to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • Patients aged 18 years to < 35 years old
  • Positive beta-hCG result
  • Diagnosed with tubal pregnancy based on pathological result.
  • 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.
  • 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)

Who cannot join

  • 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
  • BMI > 30 kg/m2
Show all 13Show fewer
  • A co-existing ectopic pregnancy
  • Refuse to participate in the study
  • Viable intrauterine pregnancy
  • BMI > 30 kg/m2
  • A co-existing ectopic pregnancy
  • Multiple pregnancies
  • Refuse to participate in the study

Trial locations and contacts

1 site in 1 country.

Minh N Chau, MD contact

903119996

bsminh.cn@myduchospital.vn

Trung T Ly, MD contact

901558786

bstrung.lt@myduchospital.vn

Vietnam1 site, 1 recruiting

  • My Duc Hospital

    Ho Chi Minh City

    Tuong M Ho, MD, MCE, +84903 633 377, tuongho.ivfmd@gmail.com

    Recruiting

Other trials in Vietnam

About this study

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.

Read the 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
Being tested
calponin 2
Keywords
CALPONIN 2, CNN2, ectopic pregnancy, tubal pregnancy
Medical subject headings
Pregnancy, Tubal, Pregnancy, Ectopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calponin 2Diagnostic test

    serum calponin 2 level

Study groups in NCT05591599
Study groupRoleWhat they receive
Case groupWomen diagnosed with tubal pregnancy
Receives: Diagnostic Test: calponin 2
Control groupWomen 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
Receives: Diagnostic Test: calponin 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The average serum CNN2 level

    The average serum CNN2 level of each group

    Measured: Up to 12 6/7 weeks of gestational age

Secondary outcomes (1)

  1. The average beta hCG level

    The average beta hCG level of each group

    Measured: Up to 12 6/7 weeks of gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start5 Dec 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
407 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591599
Sponsor's protocol ID
12/22/DD-BVMD
Acronym
CNN2
Status last verified
Oct 2022
First submitted
17 Oct 2022
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Barnhart KT. Clinical practice. Ectopic pregnancy. N Engl J Med. 2009 Jul 23;361(4):379-87. doi: 10.1056/NEJMcp0810384. No abstract available.

    PubMed 19625718

  • Shaw JL, Dey SK, Critchley HO, Horne AW. Current knowledge of the aetiology of human tubal ectopic pregnancy. Hum Reprod Update. 2010 Jul-Aug;16(4):432-44. doi: 10.1093/humupd/dmp057. Epub 2010 Jan 12.

    PubMed 20071358

  • Senapati S, Barnhart KT. Biomarkers for ectopic pregnancy and pregnancy of unknown location. Fertil Steril. 2013 Mar 15;99(4):1107-16. doi: 10.1016/j.fertnstert.2012.11.038. Epub 2013 Jan 3.

    PubMed 23290746

  • Bobdiwala S, Al-Memar M, Farren J, Bourne T. Factors to consider in pregnancy of unknown location. Womens Health (Lond). 2017 Aug;13(2):27-33. doi: 10.1177/1745505717709677. Epub 2017 Jun 29.

    PubMed 28660799

  • Wang DJ, Huang H, Wang HY, Yuan H, Du P, Wang CY, Wang YF. Association study of vascular endothelial growth factor gene polymorphisms with ectopic pregnancy in Chinese women. Clin Exp Obstet Gynecol. 2014;41(6):665-70.

    PubMed 25551960

  • Felemban A, Sammour A, Tulandi T. Serum vascular endothelial growth factor as a possible marker for early ectopic pregnancy. Hum Reprod. 2002 Feb;17(2):490-2. doi: 10.1093/humrep/17.2.490.

    PubMed 11821301

  • Rausch ME, Barnhart KT. Serum biomarkers for detecting ectopic pregnancy. Clin Obstet Gynecol. 2012 Jun;55(2):418-23. doi: 10.1097/GRF.0b013e31825109f6.

    PubMed 22510623

  • Mueller MD, Raio L, Spoerri S, Ghezzi F, Dreher E, Bersinger NA. Novel placental and nonplacental serum markers in ectopic versus normal intrauterine pregnancy. Fertil Steril. 2004 Apr;81(4):1106-11. doi: 10.1016/j.fertnstert.2003.08.049.

    PubMed 15066471

  • Senapati S, Sammel MD, Butts SF, Takacs P, Chung K, Barnhart KT. Predicting first trimester pregnancy outcome: derivation of a multiple marker test. Fertil Steril. 2016 Dec;106(7):1725-1732.e3. doi: 10.1016/j.fertnstert.2016.08.044. Epub 2016 Oct 26.

    PubMed 28340932

  • Rausch ME, Sammel MD, Takacs P, Chung K, Shaunik A, Barnhart KT. Development of a multiple marker test for ectopic pregnancy. Obstet Gynecol. 2011 Mar;117(3):573-582. doi: 10.1097/AOG.0b013e31820b3c61.

    PubMed 21343760

  • Wijayarathna R, de Kretser DM. Activins in reproductive biology and beyond. Hum Reprod Update. 2016 Apr;22(3):342-57. doi: 10.1093/humupd/dmv058. Epub 2016 Feb 15.

    PubMed 26884470

  • Florio P, Severi FM, Bocchi C, Luisi S, Mazzini M, Danero S, Torricelli M, Petraglia F. Single serum activin a testing to predict ectopic pregnancy. J Clin Endocrinol Metab. 2007 May;92(5):1748-53. doi: 10.1210/jc.2006-2188. Epub 2007 Mar 6.

    PubMed 17341564

  • Zhao Z, Zhao Q, Warrick J, Lockwood CM, Woodworth A, Moley KH, Gronowski AM. Circulating microRNA miR-323-3p as a biomarker of ectopic pregnancy. Clin Chem. 2012 May;58(5):896-905. doi: 10.1373/clinchem.2011.179283. Epub 2012 Mar 6.

    PubMed 22395025

  • Zhang R, Li S, Wang Y, Cai W, Liu Q, Zhang J. Serum calponin 2 is a novel biomarker of tubal ectopic pregnancy. Fertil Steril. 2021 Oct;116(4):1020-1027. doi: 10.1016/j.fertnstert.2021.05.101. Epub 2021 Jul 1.

    PubMed 34217487

  • Liu R, Jin JP. Calponin isoforms CNN1, CNN2 and CNN3: Regulators for actin cytoskeleton functions in smooth muscle and non-muscle cells. Gene. 2016 Jul 1;585(1):143-153. doi: 10.1016/j.gene.2016.02.040. Epub 2016 Mar 10.

    PubMed 26970176

Questions about this trial

What is this clinical trial studying?

An observational study of Tubal Pregnancy, run by Mỹ Đức Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Minh N Chau, MD (903119996, bsminh.cn@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The average serum CNN2 level (time frame: Up to 12 6/7 weeks of gestational age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05591599, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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