CA-125 and Severity of Pre-Eclampsia

• Conditions: Pre-Eclampsia
• Interventions: Other: marker(CA-125)

• Registration Number: NCT02704676
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-06
• Study First Posted: 2016-03-10
• Last Update Submitted: 2016-03-17
• Last Update Posted: 2016-03-18
• Primary Completion: 2016-07
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
increase serum CA-125 in pre-eclamptic patients	1 year	measuring serum CA-125