Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Women diagnosed with tubal pregnancy |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calponin 2 | Diagnostic Test | serum calponin 2 level |
|
| Measure | Description | Time Frame |
|---|---|---|
| The average serum CNN2 level | The average serum CNN2 level of each group | Up to 12 6/7 weeks of gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| The average beta hCG level | The average beta hCG level of each group | Up to 12 6/7 weeks of gestational age |
Not provided
Case: tubal pregnancy
Inclusion criteria
Exclusion criteria
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
Exclusion criteria
Viable intrauterine pregnancy
Inclusion criteria
Exclusion criteria
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minh N Chau, MD | Contact | 903119996 | bsminh.cn@myduchospital.vn | |
| Trung T Ly, MD | Contact | 901558786 | bstrung.lt@myduchospital.vn |
| Name | Affiliation | Role |
|---|---|---|
| Minh N Chau, MD | Mỹ Đức Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Duc Hospital | Recruiting | Ho Chi Minh City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19625718 | Result | Barnhart KT. Clinical practice. Ectopic pregnancy. N Engl J Med. 2009 Jul 23;361(4):379-87. doi: 10.1056/NEJMcp0810384. No abstract available. | |
| 20071358 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011274 | Pregnancy, Tubal |
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Use blood test to measure serum calponin 2 level
| 23290746 | Result | 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. |
| 28660799 | Result | 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. |
| 25551960 | Result | 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. |
| 11821301 | Result | 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. |
| 22510623 | Result | Rausch ME, Barnhart KT. Serum biomarkers for detecting ectopic pregnancy. Clin Obstet Gynecol. 2012 Jun;55(2):418-23. doi: 10.1097/GRF.0b013e31825109f6. |
| 15066471 | Result | 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. |
| 28340932 | Result | 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. |
| 21343760 | Result | 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. |
| 26884470 | Result | 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. |
| 17341564 | Result | 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. |
| 22395025 | Result | 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. |
| 34217487 | Result | 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. |
| 26970176 | Result | 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. |
| 16236705 | Result | 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. |