Pre-EclampsiaNCT02704676
CA-125 and Severity of Pre-Eclampsia
An observational study of Pre-Eclampsia, run by Ain Shams Maternity Hospital.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- marker(CA-125)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- pregnant women 3rd trimester
- any age
- medically free at least by history
- signs and or symptoms of pre-eclampsia
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.
Read the 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.
- Conditions
- Pre-Eclampsia
- Being tested
- marker(CA-125)
- Keywords
- CA-125, Pre-Eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marker(CA-125)Other
measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)
| Study group | Role | What they receive |
|---|---|---|
| control patients | normal pregnant women, 3rd trimester Receives: Other: marker(CA-125) | |
| mild pre-eclampsia | patients with albuminuria +1 and blood pressure >140/90 and <160/110 Receives: Other: marker(CA-125) | |
| sever pre-eclampsia | patients diagnosed as sever pre-eclampsia according to criteria done by ACOG Receives: Other: marker(CA-125) |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase serum CA-125 in pre-eclamptic patients
measuring serum CA-125
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
- Investigators
- Hassan Tawfek, Pofessor, Study director, ain-shams university , cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704676
- Sponsor's protocol ID
- CA125
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 19437230
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CA-125 and Severity of Pre-Eclampsia
- ClinicalTrials.gov ID
- NCT02704676
- Acronym / sponsor ID
- CA125
- Conditions
- Pre-Eclampsia
- Keywords
- CA-125, Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control patients | – | Other: marker(CA-125)normal pregnant women, 3rd trimester |
| mild pre-eclampsia | – | Other: marker(CA-125)patients with albuminuria +1 and blood pressure >140/90 and <160/110 |
| sever pre-eclampsia | – | Other: marker(CA-125)patients diagnosed as sever pre-eclampsia according to criteria done by ACOG |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- pregnant women 3rd trimester
- any age
- medically free at least by history
- signs and or symptoms of pre-eclampsia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| marker(CA-125)measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia) | Other | control patients, mild pre-eclampsia, sever pre-eclampsia |
Primary outcome
increase serum CA-125 in pre-eclamptic patients
Time frame: 1 year
measuring serum CA-125
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Background: PubMed 19437230Cebesoy 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
RecruitingPhase 3
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
Preeclampsia
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Tawfek, Pofessor study director
ain-shams university , cairo
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Ain Shams Maternity Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Ibrahim, MBBCH (01007378387, dr.marwa_2010@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase serum CA-125 in pre-eclamptic patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704676, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.