CA-125 and Severity of Pre-Eclampsia

Ain Shams Maternity Hospital

Status: Unknown

Conditions: Pre-Eclampsia

Treatments: Other: marker(CA-125)

Study type: Observational

Funder types: Other

Identifiers

NCT02704676

CA125

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

control patients

Description:

normal pregnant women, 3rd trimester

Treatment:

Other: marker(CA-125)

mild pre-eclampsia

Description:

patients with albuminuria +1 and blood pressure \>140/90 and \<160/110

Treatment:

Other: marker(CA-125)

sever pre-eclampsia

Description:

patients diagnosed as sever pre-eclampsia according to criteria done by ACOG

Treatment:

Other: marker(CA-125)