Clinical trial NCT03554681: Prediction of Preeclampsia (PE) at 11-13 Week
Official title: Prospective Validation of Prediction Algorithms for Preeclampsia in the First-trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Keywords: Bayes Model
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 10935
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible women attending for their hospital visit at 11-13 weeks will be invited to participate.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The false positive and true positive frequencies for screening for PE using the Bayes theorem based methods
timeFrame: At delivery
Secondary outcomes:
measure: 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
timeFrame: At delivery
Other outcomes:
Locations:
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Hong Kong
country: Hong Kong
facility: Kwong Wah Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Chennai
country: India
facility: Mediscan Chennai
state: Tamil Nadu
city: Toyama
country: Japan
facility: Toyama University Hospital
state: Toyama Prefecture
city: Osaka
country: Japan
facility: Clinical Research Institute of Fetal Medicine PMC
city: Tokyo
country: Japan
facility: Affiliated hospitals within The Japan Society for the Study of Hypertension in Pregnancy (JSSHP)
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Taipei
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University Bangkok
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Liona CY Poon
role: PRINCIPAL_INVESTIGATOR
References:
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. Available from http://www.ncbi.nlm.nih.gov/books/NBK62652/
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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.
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