NCT05591599

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
407

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 16, 2023

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

October 17, 2022

Last Update Submit

March 15, 2023

Conditions

Tubal Pregnancy

Keywords

CALPONIN 2CNN2ectopic pregnancytubal pregnancy

Outcome Measures

Primary Outcomes (1)

  • The average serum CNN2 level

    The average serum CNN2 level of each group

    Up to 12 6/7 weeks of gestational age

Secondary Outcomes (1)

  • The average beta hCG level

    Up to 12 6/7 weeks of gestational age

Study Arms (2)

Case group

Women diagnosed with tubal pregnancy

Diagnostic Test: calponin 2

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

Interventions

calponin 2DIAGNOSTIC_TEST

serum calponin 2 level

Case groupControl group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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
  • 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.
  • BMI \> 30 kg/m2
  • A co-existing ectopic pregnancy
  • Refuse to participate in the study
  • Viable intrauterine pregnancy
  • 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)
  • BMI \> 30 kg/m2
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Vietnam

RECRUITING

Related 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.

    PMID: 19625718RESULT

  • 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.

    PMID: 20071358RESULT

  • 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.

    PMID: 23290746RESULT

  • 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.

    PMID: 28660799RESULT

  • 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.

    PMID: 25551960RESULT

  • 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.

    PMID: 11821301RESULT

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

    PMID: 22510623RESULT

  • 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.

    PMID: 15066471RESULT

  • 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.

    PMID: 28340932RESULT

  • 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.

    PMID: 21343760RESULT

  • 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.

    PMID: 26884470RESULT

  • 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.

    PMID: 17341564RESULT

  • 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.

    PMID: 22395025RESULT

  • 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.

    PMID: 34217487RESULT

  • 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.

    PMID: 26970176RESULT

  • 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.

    PMID: 16236705RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Use blood test to measure serum calponin 2 level

MeSH Terms

Conditions

Pregnancy, TubalPregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Minh N Chau, MD

    Mỹ Đức Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh N Chau, MD

CONTACT

903119996bsminh.cn@myduchospital.vn

Trung T Ly, MD

CONTACT

901558786bstrung.lt@myduchospital.vn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 24, 2022

Study Start

December 5, 2022

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

March 16, 2023

Record last verified: 2022-10

Locations

VN(1)