CA-125 and Severity of Pre-Eclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-30

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.

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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.

Conditions

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Pre-Eclampsia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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control patients

normal pregnant women, 3rd trimester

marker(CA-125)

Intervention Type OTHER

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

mild pre-eclampsia

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

marker(CA-125)

Intervention Type OTHER

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

sever pre-eclampsia

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

marker(CA-125)

Intervention Type OTHER

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

Interventions

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marker(CA-125)

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

Intervention Type OTHER

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes