Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

NCT04021680 — Unknown, 2000 participants, Far Eastern Memorial Hospital

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Far Eastern Memorial Hospital

RegistryNCT04021680
StatusUnknown
Study typeObservational
Enrollment2000 (Estimated)
SponsorFar Eastern Memorial Hospital (Other); collaborators: Gynecologic Oncology Group
ConditionsPre-eclampsia
Interventionspre-eclampsia screening program (Other)
Datesstart 2019-06-10, primary completion 2025-06-20 (estimated), completion 2025-06-20 (estimated), first posted 2019-07-16, last updated 2023-03-29
Locations1 site in Taiwan

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-Summary

To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

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+Detailed description

The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.

In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

+Arms and interventions

  • pre-eclampsia screening program (Other): This screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia.

+Outcome measures

Primary outcomes

  • The sensitivity and specificity of this screening program to detect preeclampsia [5 years]

+Eligibility

Sex: Female, ages: 20 Years to any

Inclusion Criteria:

\- Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.

Exclusion Criteria:

* Women who are not regularly inspected or not receiving prenatal care in this institution.
* Women who received first trimester pre-eclampsia screening test at other institution

+Locations (1)

FacilityCityCountryStatus
Department of Obstetrics and Gynecology, Far-Eastern Memorial HospitalBanqiao District, New TaipeiTaiwanRecruiting