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

NCT02854501 | Completed DMC

• 1 other identifier: 153
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Preeclampsia

Keywords

Homocysteine; Preeclampsia; poor placentation

Outcome Measures

Primary Outcomes (1)

• development of placentation disorders

  28-40 weeks gestational age

Study Arms (4)

Uncomplicated pregnancies

women who did not develop any of the complications

Preeclampsia

pregnant women who developed preeclampsia

Isolated IUGR

participants were those who had IUGR

Any complication

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Spontaneous pregnancies without history of risk factors for preeclampsia were enrolled in the current study

You may qualify if:

• Spontaneous pregnancies without history of previous risk factors for preeclampsia

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 28689278 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The plasma tHcy concentrations were measured by means of a fluorescence polarization immunoassay

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Maged

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 3, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share