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CA-125 and Severity of Pre-Eclampsia

CA-125 and Severity of Pre-Eclampsia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02704676
Enrollment
120
Registered
2016-03-10
Start date
2016-03-31
Completion date
2016-09-30
Last updated
2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Keywords

CA-125, Pre-Eclampsia

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.

Interventions

OTHERmarker(CA-125)

measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
increase serum CA-125 in pre-eclamptic patients1 yearmeasuring serum CA-125

Contacts

Primary ContactMarwa M Ibrahim, MBBCH
dr.marwa_2010@yahoo.com01007378387
Backup ContactAhmed M Bahaa eldin, A.Professor
abahaa0503@med.asu.edu.eg+20 1111700556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026