Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

Tubal Pregnancy Clinical Trial

— CNN2  

Official title:

Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591599
• Other study ID #: 12/22/DD-BVMD
• Status: Recruiting
• Start date: December 5, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2022
• Source: M? Ð?c Hospital
• Contact: Minh N Chau, MD
• Phone: 903119996
• Email: bsminh.cn[@]myduchospital.vn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 407
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Tubal Pregnancy

Intervention

Diagnostic Test:
• calponin 2
serum calponin 2 level

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
M? Ð?c Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (16)

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

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. — View Citation

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. — View Citation

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. — View Citation

Hossain MM, Crish JF, Eckert RL, Lin JJ, Jin JP. h2-Calponin is regulated by mechanical tension and modifies the function of actin cytoskeleton. J Biol Chem. 2005 Dec 23;280(51):42442-53. doi: 10.1074/jbc.M509952200. Epub 2005 Oct 18. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average serum CNN2 level	The average serum CNN2 level of each group	Up to 12 6/7 weeks of gestational age
Secondary	The average beta hCG level	The average beta hCG level of each group	Up to 12 6/7 weeks of gestational age