CA-125 and Severity of Pre-Eclampsia

March 17, 2016 updated by: Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Although the source of CA-125 during pregnancy is the fetal chorion, amniotic fluid, and maternal decidua, the perinatal dynamics of maternal serum CA-125 requires clarification. Clinical studies of CA-125 levels and its function in hypertensive pregnant patients are limited and offered contradictory results (Cebesoy et al., 2009).

And so we investigate CA-125 in normal pregnancy and in pre-eclampsia, comparing mild and sever pre-eclampsia to determine relationship of CA-125 and severity of the disease.

Patients will be divided in three groups:

  • Control: 40 normal healthy pregnant women attending the ER in labor.

  • Mild pre-eclampsia: 40 patients fulfilling the following criteria.

    • Blood pressure: systolic blood pressure >140 and <160 , Diastolic blood pressure >90 and <110
    • Proteinuria: 300 mg (+) assessed by urine urignost 3A® (urine strips from DIALAB).
    • No symptoms of severity as headache.
    • Normal investigations for different organ function (as liver and kidney function).

  • Severe pre-eclampsia :40 patients fulfilling anyone or more of the following criteria (The American College of Obstetricians and Gynecologists, 2010)(ACOG):

    • Systolic blood pressure > 160 mmHg
    • Diastolic blood pressure > 110 mmHg (on two occasions at least 6 hours apart while the patient is on bed rest)
    • Proteinuria of 5000mg (5g) or higher on a 24-hour urine collection or at least 3+ on two random urine samples collected at least 4 hours apart
    • Oliguria < 500 mL urine output in 24 hours
    • Cerebral or visual functional disturbances (cns irritability)
    • Pulmonary edema or cyanosis (not due to excessive intravenous volume replacement)
    • Epigastric or right-upper quadrant abdominal pain
    • Impaired liver function on laboratory analysis (elevated aspartate aminotransferase (AST), alanine amino transferase(ALT), or lactate dehydrogenase(LDH))
    • Thrombocytopenia (platelet count < 150,000/uL)
    • Fetal growth restriction.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population comprises pregnant women once diagnosed pre-eclampsia, attending to Ain Shams University Maternity Hospital, or for antinatal care of the corrosponding gestational age.

Description

Inclusion criteria:

  • pregnant women 3rd trimester
  • any age
  • medically free at least by history
  • signs and or symptoms of pre-eclampsia

Exclusion Criteria:

  • Other causes elevate CA-125 as: ovarian cancer, endometrial cancer, breast cancer and benign conditions as: endometriosis and liver cirrhosis.

Chronic hypertension

  • Diabetes Mellitus (DM)
  • Liver diseases
  • Thyroid disorders
  • Kidney diseases
  • Cardiac diseases

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control patients
normal pregnant women, 3rd trimester
Other: marker(CA-125)
measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)
mild pre-eclampsia
patients with albuminuria +1 and blood pressure >140/90 and <160/110
Other: marker(CA-125)
measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)
sever pre-eclampsia
patients diagnosed as sever pre-eclampsia according to criteria done by ACOG
Other: marker(CA-125)
measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
increase serum CA-125 in pre-eclamptic patients
Time Frame: 1 year
measuring serum CA-125
1 year

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Hassan Tawfek, Pofessor, ain-shams university , cairo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 6, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 17, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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