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CA-125 and Severity of Pre-Eclampsia

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ClinicalTrials.gov Identifier: NCT02704676
Recruitment Status : Unknown
Verified March 2016 by Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 18, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

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.

Condition or disease Intervention/treatment
Pre-Eclampsia Other: marker(CA-125)

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: CA-125 and Severity of Pre-Eclampsia
Study Start Date : March 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control patients
normal pregnant women, 3rd trimester
Other: marker(CA-125)
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
Other: marker(CA-125)
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
Other: marker(CA-125)
measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)




Primary Outcome Measures :
  1. increase serum CA-125 in pre-eclamptic patients [ Time Frame: 1 year ]
    measuring serum CA-125



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704676


Contacts
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Contact: Marwa M Ibrahim, MBBCH 01007378387 dr.marwa_2010@yahoo.com
Contact: Ahmed M Bahaa eldin, A.Professor +20 1111700556 abahaa0503@med.asu.edu.eg

Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Director: Hassan Tawfek, Pofessor ain-shams university , cairo

Publications:
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Responsible Party: Ahmed Mohamed Bahaa Eldin Ahmed, Clinical professor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02704676     History of Changes
Other Study ID Numbers: CA125
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital:
CA-125
Pre-Eclampsia
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications