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

NCT ID: NCT02541110

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preeclampsia IUGR

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* spontaneous pregnancies with no risk factors

Exclusion Criteria

* multiple pregnancies
* non intact renal function
* hypertension
* diabetes
* folic acid supplements
* antifolate drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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suzy abdelaziz Abdelhamid

lecturer of Obgyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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suzy abdelaziz, M.D.

Role: PRINCIPAL_INVESTIGATOR

kasrelaini hospital

Central Contacts

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suzy abdelaziz, M.D.

Role: CONTACT

01003726195

Other Identifiers

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Obgyn. .

Identifier Type: -

Identifier Source: org_study_id

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