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

NCT ID: NCT02854501

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

Brief 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).

Detailed 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

Conditions

Preeclampsia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Uncomplicated pregnancies

women who did not develop any of the complications

No interventions assigned to this group

Preeclampsia

pregnant women who developed preeclampsia

No interventions assigned to this group

Isolated IUGR

participants were those who had IUGR

No interventions assigned to this group

Any complication

participants who developed other complications (abruptio placentae, stillbirth, or preterm labor).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

References

Maged AM, Saad H, Meshaal H, Salah E, Abdelaziz S, Omran E, Deeb WS, Katta M. Maternal serum homocysteine and uterine artery Doppler as predictors of preeclampsia and poor placentation. Arch Gynecol Obstet. 2017 Sep;296(3):475-482. doi: 10.1007/s00404-017-4457-y. Epub 2017 Jul 8.

Reference Type: DERIVED

PMID: 28689278 (View on PubMed)

Other Identifiers

153

Identifier Type: -

Identifier Source: org_study_id