Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders

Preeclampsia Clinical Trial

Official title:

Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Poor Placentation Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854501
• Other study ID #: 153
• Status: Completed
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current study included the singleton pregnancies (without history of previous risk factors), had their homocysteine measured as part of a serum-screening program in addition to uterine artery Doppler. Sensitivity, specificity, positive and negative predictive values, for development of preeclampsia and other adverse pregnancy outcomes were assessed as follows; (1) Homocysteine cutoff level at 6.3 µmol/l; (2) Bilateral notches on Doppler with a mean RI >0.5, all unilateral notches with a mean RI >0.6, in addition, absence of notches with a mean RI >0.7; (3) Doppler assessment combined with the homocysteine cutoff (6.3 µmol/l).

Description:

These participants had uterine artery Doppler investigations, as part of a routine scan between the 18th and the 22nd week of pregnancy. The investigators were blinded to the results of the biochemistry results.

All samples of the tHcy measurement were collected between 15 and 19 weeks of gestational age, as calculated from the last menstrual period or from early ultrasound dates (when the menstrual dates differed from the specified gestation). The plasma tHcy concentrations were measured by means of a fluorescence polarization immunoassay (9).

Uterine artery flow velocity waveforms were obtained using an SD 800 Doppler system (Philips Medical Systems, Gland, Switzerland) with a 3.5/5-MHz linear array probe. The high-pass filter was set at 100 Hz. One operator performed the measurements. The use of mean resistance index (RI) cutoff points with bilateral and unilateral notches has already been shown to improve the efficacy of uterine artery Doppler screening using qualitative assessment (10). A screen-positive or abnormal result was defined as bilateral notches and a mean RI >0.55 (50th centile), unilateral notches and a mean RI >0.65 (80th centile), and absence of notches and a mean RI >0.7 (95th centile) (11). Women with these abnormal results were offered growth scans, amniotic fluid volume assessment, and umbilical artery Doppler every 4 weeks until 36 weeks in view of the recognized increased risk of isolated IUGR (12), unless there were other clinical indications, which necessitated closer surveillance

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Spontaneous pregnancies without history of previous risk factors for preeclampsia

Exclusion Criteria:

• multiple pregnancy, non-intact renal function, and hypertension before 20 weeks of gestation, diabetes mellitus and/or chronic diseases, women taking folic acid supplementations, women using antifolate drugs, and maternal age more than 40 years

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of placentation disorders		28-40 weeks gestational age