CA-125 and Severity of Pre-Eclampsia

Study Overview
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Brief Summary
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The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.

Detailed Description
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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.

Official Title
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CA-125 and Severity of Pre-Eclampsia

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Other: marker(CA-125)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CA-125, Pre-Eclampsia