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

September 3, 2015 updated by: suzy abdelaziz Abdelhamid, Kasr El Aini Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Spontaneous pregnancies with no risk factors

Description

Inclusion Criteria:

  • spontaneous pregnancies with no risk factors

Exclusion Criteria:

  • multiple pregnancies
  • non intact renal function
  • hypertension
  • diabetes
  • folic acid supplements
  • antifolate drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of pregnants who developed preeclampsia, those who developed IUGR alone and those who developed other obstetric complications as preterm labour and placental abruption
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Principal Investigator: suzy abdelaziz, M.D., kasrelaini hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obgyn. .

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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