Prediction of Preeclampsia (PE) at 11-13 Week

Pre-Eclampsia Clinical Trial

Official title:

Prospective Validation of Prediction Algorithms for Preeclampsia in the First-trimester of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554681
• Other study ID #: 2016.152
• Status: Completed
• Start date: December 2016
• Est. completion date: September 2019

Study information

• Verified date: December 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an international multicentre prospective cohort study to validate the Bayes theorem based algorithms for the screening of pre-eclampsia (PE) in the first-trimester of pregnancy.

Description:

The investigators have previously constructed Bayes model in the first-trimester which combines maternal characteristics and medical history (Mat-CH) together with mean arterial pressure (MAP), uterine artery pulsatility index (PI), and serum placental growth factor (PlGF) with a plan to assess the predictive performance.

The reference standards will be PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists. The systolic blood pressure should be >140 mm Hg and/or the diastolic blood pressure should be >90 mmHg on at least two occasions four hours apart developing after 20 weeks' gestation in previously normotensive women and there should be proteinuria (>300 mg in 24 hours or two readings of at >2+ on dipstick analysis of midstream or catheter urine specimens if no 24-hour collection is available). In the absence of proteinuria, new onset of any of the following systemic findings: a) thrombocytopaenia (platelet counts <100,000 µL); b) renal insufficiency (creatinine >1.1 mg/dL or 2-fold increase in creatinine in the absence of underlying renal disease); c) abnormal liver function (ie, hepatic transaminase levels twice normal); d) pulmonary oedema; or e) cerebral or visual symptoms. Preterm-PE is PE that requires delivery before 37 weeks' gestation. If a participant fulfills the criteria for PE by one definition and not the other she will be considered to have developed PE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10935
• Est. completion date: September 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged = 18 years

• Singleton pregnancy

• Live fetus

• Provide Informed and written consent in the official language of the country

Exclusion Criteria:

• Unable to provide written Informed consent learning difficulties or serious mental illness or an inability to understand spoken and written the official language of the country.

• Multiple Pregnancy

• Non-viable fetus (missed spontaneous abortion or stillbirth)

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Locations

Country	Name	City	State
China	First Affiliated Hospital of Kunming Medical University	Kunming
China	Nanjing Drum Tower Hospital	Nanjing
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong
India	Mediscan Chennai	Chennai	Tamil Nadu
Japan	Clinical Research Institute of Fetal Medicine PMC	Osaka
Japan	Affiliated hospitals within The Japan Society for the Study of Hypertension in Pregnancy (JSSHP)	Tokyo
Japan	Showa University Hospital	Tokyo
Japan	Toyama University Hospital	Toyama	Toyama Prefecture
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital	Singapore
Taiwan	Taipei Chang Gung Memorial Hospital	Taipei
Thailand	Chulalongkorn University Bangkok	Bangkok
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chiu Yee Liona Poon

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Japan,  Singapore,  Taiwan,  Thailand, 

References & Publications (15)

Acharya G, Wilsgaard T, Berntsen GK, Maltau JM, Kiserud T. Reference ranges for serial measurements of umbilical artery Doppler indices in the second half of pregnancy. Am J Obstet Gynecol. 2005 Mar;192(3):937-44. — View Citation

American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-31. doi: 10.1097/01.AOG.0000437382.03963.88. — View Citation

Andrietti S, Silva M, Wright A, Wright D, Nicolaides KH. Competing-risks model in screening for pre-eclampsia by maternal factors and biomarkers at 35-37 weeks' gestation. Ultrasound Obstet Gynecol. 2016 Jul;48(1):72-9. doi: 10.1002/uog.15812. Epub 2016 May 30. — View Citation

Askie LM, Duley L, Henderson-Smart DJ, Stewart LA; PARIS Collaborative Group. Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data. Lancet. 2007 May 26;369(9575):1791-1798. doi: 10.1016/S0140-6736(07)60712-0. Review. — View Citation

Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. Review. — View Citation

Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguère Y. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):402-14. doi: 10.1097/AOG.0b013e3181e9322a. — View Citation

Gallo DM, Wright D, Casanova C, Campanero M, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 19-24 weeks' gestation. Am J Obstet Gynecol. 2016 May;214(5):619.e1-619.e17. doi: 10.1016/j.ajog.2015.11.016. Epub 2015 Nov 25. — View Citation

National Collaborating Centre for Women's and Children's Health (UK). Hypertension in Pregnancy: The Management of Hypertensive Disorders During Pregnancy. London: RCOG Press; 2010 Aug. — View Citation

O'Gorman N, Wright D, Syngelaki A, Akolekar R, Wright A, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks gestation. Am J Obstet Gynecol. 2016 Jan;214(1):103.e1-103.e12. doi: 10.1016/j.ajog.2015.08.034. Epub 2015 Aug 19. — View Citation

Roberge S, Giguère Y, Villa P, Nicolaides K, Vainio M, Forest JC, von Dadelszen P, Vaiman D, Tapp S, Bujold E. Early administration of low-dose aspirin for the prevention of severe and mild preeclampsia: a systematic review and meta-analysis. Am J Perinatol. 2012 Aug;29(7):551-6. doi: 10.1055/s-0032-1310527. Epub 2012 Apr 11. Review. Erratum in: Am J Perinatol. 2014 Jun;31(6):e3. von Dadelzen, Peter [corrected to von Dadelszen, Peter]. — View Citation

Roberge S, Villa P, Nicolaides K, Giguère Y, Vainio M, Bakthi A, Ebrashy A, Bujold E. Early administration of low-dose aspirin for the prevention of preterm and term preeclampsia: a systematic review and meta-analysis. Fetal Diagn Ther. 2012;31(3):141-6. doi: 10.1159/000336662. Epub 2012 Mar 21. Review. — View Citation

Snijders RJ, Nicolaides KH. Fetal biometry at 14-40 weeks' gestation. Ultrasound Obstet Gynecol. 1994 Jan 1;4(1):34-48. — View Citation

Tsiakkas A, Saiid Y, Wright A, Wright D, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 30-34 weeks' gestation. Am J Obstet Gynecol. 2016 Jul;215(1):87.e1-87.e17. doi: 10.1016/j.ajog.2016.02.016. Epub 2016 Feb 12. — View Citation

Vyas S, Campbell S, Bower S, Nicolaides KH. Maternal abdominal pressure alters fetal cerebral blood flow. Br J Obstet Gynaecol. 1990 Aug;97(8):740-2. — View Citation

Wright D, Syngelaki A, Akolekar R, Poon LC, Nicolaides KH. Competing risks model in screening for preeclampsia by maternal characteristics and medical history. Am J Obstet Gynecol. 2015 Jul;213(1):62.e1-62.e10. doi: 10.1016/j.ajog.2015.02.018. Epub 2015 Feb 25. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods		At delivery
Secondary	The false positive and true positive frequencies for screening of delivery of all-Small for Gestational Age (SGA) neonates and preterm-SGA neonates (delivery before 37 weeks), with or without PE		At delivery