Pre-EclampsiaNCT03214393
Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy
An observational study of Pre-Eclampsia, run by Cairo University at 1 site in Egypt.
Trial summary
Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Doppler and serum antibodies
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 30 Aug 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant females 32 weeks gestation or more with pre-eclampsia
Who may be able to join
- Pregnant women 32 weeks or more gestational age
- Pre-eclampsia
- Singleton pregnancy
Who cannot join
- Intrauterine fetal death
- Fetus with apparent congenital anomalies
- Pregnant females with other medical disorders
- History of essential hypertension.
- History of antepartum hemorrhage.
- History of rupture of membranes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology
Cairo, Greater Cairo, 11956
Doaa Belal, MD, 0020223682030, doaash@live.com
About this study
Official title: Role of Maternal Anticardiolipin and Anti-B2 Glycoprotein I Antibodies in Correlation With Fetal Doppler in Prediction of Adverse Pregnancy Outcome in Patients With Preeclampsia
Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.
Read the detailed description
Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.
- Conditions
- Pre-Eclampsia
- Being tested
- Doppler, serum antibodies
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopplerDiagnostic test
Doppler will be done to pregnant women with Pre-Eclampsia
serum antibodiesDiagnostic test
serum antibodies will be measured for pregnant women with Pre-Eclampsia
| Study group | Role | What they receive |
|---|---|---|
| Pre-Eclampsia | pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler Receives: Diagnostic Test: Doppler; Diagnostic Test: serum antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of cases that develop severe pre-eclampsia
percentage of cases that develop severe pre-eclampsia will be assessed by an investigator
Measured: It will be calculated after 1 year from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Shafie Belal, Cairo University
- Investigators
- Doaa Sh Belal, MD, Principal investigator, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214393
- Sponsor's protocol ID
- 3650
- Status last verified
- Jul 2017
- First submitted
- 10 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Maternal Anticardiolipin and Anti-B2 Glycoprotein I Antibodies in Correlation With Fetal Doppler in Prediction of Adverse Pregnancy Outcome in Patients With Preeclampsia
- ClinicalTrials.gov ID
- NCT03214393
- Acronym / sponsor ID
- 3650
- Conditions
- Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- 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.
Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.
Detailed description
Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-Eclampsia | – | Diagnostic Test: Doppler, Diagnostic Test: serum antibodiespregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant females 32 weeks gestation or more with pre-eclampsia
Key inclusion criteria (3 listed)
- Pregnant women 32 weeks or more gestational age
- Pre-eclampsia
- Singleton pregnancy
Key exclusion criteria (6 listed)
- Intrauterine fetal death
- Fetus with apparent congenital anomalies
- Pregnant females with other medical disorders
- History of essential hypertension.
- History of antepartum hemorrhage.
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 |
|---|---|---|
| DopplerDoppler will be done to pregnant women with Pre-Eclampsia | Diagnostic test | Pre-Eclampsia |
| serum antibodiesserum antibodies will be measured for pregnant women with Pre-Eclampsia | Diagnostic test | Pre-Eclampsia |
Primary outcome
percentage of cases that develop severe pre-eclampsia
Time frame: It will be calculated after 1 year from the start of the study
percentage of cases that develop severe pre-eclampsia will be assessed by an investigator
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Doaa Sh Belal, MD principal investigator
Cairo U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 6 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Doaa Sh Belal, MD (0020223682030, doaash@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of cases that develop severe pre-eclampsia (time frame: It will be calculated after 1 year from the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2017.