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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT02854501
Collaborator
(none)
230
18

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    230 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Poor Placentation Disorders
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Uncomplicated pregnancies

    Preeclampsia

    Isolated IUGR

    Any complication

    Outcome Measures

    Primary Outcome Measures

    1. development of placentation disorders [28-40 weeks gestational age]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Maged, Kasr Alainy medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02854501
    Other Study ID Numbers:
    • 153
    First Posted:
    Aug 3, 2016
    Last Update Posted:
    Aug 3, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Ahmed Maged, Assistant professor, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2016