Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler

Preeclampsia Clinical Trial

Official title:

Second Trimester Maternal Serum Homocysteine Level & Uterine Artery Doppler for Prediction of Preeclampsia , Intra-Uterine Growth Retardation (IUGR) & Other Obstetric Complications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02541110
• Other study ID #: Obgyn. .
• Status: Not yet recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: September 3, 2015
• Start date: September 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2015
• Source: Kasr El Aini Hospital
• Contact: suzy abdelaziz, M.D.
• Phone: 01003726195
• Email: suzyabdelaziz92[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial Summary

Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) & other obstetric complications.

Description:

Spontaneous pregnancies with no risk factors will be included. Fasting plasma total homocysteine level samples will be collected between 15th & 19th weeks.

Uterine artery doppler between 18th & 22nd weeks.

Method 1: Screen positive cases will be considered if homocysteine level above 6.3umol/l

Method 2: Screen positive cases will be considered if they had bilateral notches and a mean resistivity index (RI) above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7.

Method 3: Screen positive cases will be considered if they had bilateral notches and a mean RI above 0.55, or unilateral notches and a mean RI above 0.65, or absence of notches and a mean RI above 0.7 combined with homocysteine cut off value of 6.3umol / l.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• spontaneous pregnancies with no risk factors

Exclusion Criteria:

• multiple pregnancies

• non intact renal function

• hypertension

• diabetes

• folic acid supplements

• antifolate drugs

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Growth Retardation
• IUGR
• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption		4 months	Yes