NCT02704676

CA-125 and Severity of Pre-Eclampsia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Ain Shams Maternity Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pre-Eclampsia

Interventions

Type	Name	Description
OTHER	marker(CA-125)	measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2016-03-10
• Last updated: 2016-03-18