Clinical Trials Logo
  1. Home
  2. Pre-eclampsia
  3. NCT04021680
  4. Details
NCT04021680 Clinical Trial

Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

Pre-eclampsia Clinical Trial

Official title:
Far Eastern Memorial Hospital

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04021680
Other study ID # 108051-F
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 10, 2019
Est. completion date June 20, 2025

Study information
Verified date March 2023
Source Far Eastern Memorial Hospital
Contact Sheng-Mou Hsiao, MD
Phone +88689667000
Email smhsiao2@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date June 20, 2025
Est. primary completion date June 20, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital Banqiao New Taipei

Sponsors (2)
Lead Sponsor Collaborator
Far Eastern Memorial Hospital Gynecologic Oncology Group

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The sensitivity and specificity of this screening program to detect preeclampsia 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT03299777 - Correlation Between Changes in Liver Stiffness and Preeclampsia as Shown by Fibroscan N/A
Completed NCT03650790 - C1q/TNF-related Protein 9 (CTRP 9) Level in Preeclamptic Obese and Non-obese Pregnancies N/A
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Not yet recruiting NCT03302260 - Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial N/A
Completed NCT02911701 - Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features Phase 4
Completed NCT01911494 - Community Level Interventions for Pre-eclampsia N/A
Terminated NCT02025426 - Phenylephrine Versus Ephedrine in Pre-eclampsia Phase 4
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Active, not recruiting NCT02031393 - Establishing First Trimester Markers for the Identification of High Risk Twin N/A
Terminated NCT00141310 - Sildenafil Citrate for the Treatment of Established Pre-Eclampsia Phase 2
Completed NCT00157521 - L-Arginine in Pre-Eclampsia Phase 3
Completed NCT04795154 - Prenatal Yoga as Complementary Therapy of Preeclampsia N/A
Completed NCT00004399 - Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia N/A
Completed NCT00005207 - Renin and Prorenin in Pregnancy N/A
Recruiting NCT04551807 - Natural Versus Programmed Frozen Embryo Transfer (NatPro) Phase 3
Terminated NCT04092829 - Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer N/A
Recruiting NCT06067906 - Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients N/A
Recruiting NCT06317467 - Role of Anti-C1q Autoantibodies in Pregnancy
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Active, not recruiting NCT04484766 - Preeclampsia Associated Vascular Aging