Clinical trial NCT02704676: CA-125 and Severity of Pre-Eclampsia
Official title: CA-125 and Severity of Pre-Eclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Keywords: CA-125
Pre-Eclampsia
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises pregnant women once diagnosed pre-eclampsia, attending to Ain Shams University Maternity Hospital, or for antinatal care of the corrosponding gestational age.

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.

Eligibility criteria: 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

Primary outcomes:
measure: increase serum CA-125 in pre-eclamptic patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ain-shams university , cairo
name: Hassan Tawfek, Pofessor
role: STUDY_DIRECTOR
References:
citation: Cebesoy FB, Balat O, Dikensoy E, Kalayci H, Ibar Y. CA-125 and CRP are elevated in preeclampsia. Hypertens Pregnancy. 2009 May;28(2):201-11. doi: 10.1080/10641950802601187.