CA-125 and Severity of Pre-Eclampsia

Pre-Eclampsia Clinical Trial

Official title:

CA-125 and Severity of Pre-Eclampsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02704676
• Other study ID #: CA125
• Status: Not yet recruiting
• Phase: N/A
• First received: March 3, 2016
• Last updated: March 17, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Ain Shams Maternity Hospital
• Contact: Marwa M Ibrahim, MBBCH
• Phone: 01007378387
• Email: dr.marwa_2010[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase serum CA-125 in pre-eclamptic patients	measuring serum CA-125	1 year	Yes