Antiphospholipid Syndrome in PregnancyNCT03505840
The Value of Placental Vascularization and Placental Volume in Pregnancy in APLS
An observational study of Antiphospholipid Syndrome in Pregnancy, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Antiphospholipid antibodies are autoantibodies directed against phospholipid-binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid Syndrome in Pregnancy
- What is being tested?
- Ultrasound with Doppler and 3D technology
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Apr 2018to 10 Oct 2020
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Singleton pregnancy. * Gestational age of 34-37 weeks. * Pregnant women with antiphospholipid syndrome
Who may be able to join
- Singleton pregnancy.
- Gestational age of 34-37 weeks.
- Pregnant women with antiphospholipid syndrome
Who cannot join
- Twin or multiple pregnancies.
- Congenital fetal anomalies.
- Gestational age of less than 34.
- Gestational age of more than 37.
- Women with placental or umbilical artery anomalies.
- Antepartum hemorrhage (placental abruption, placenta previa and vasa previa).
Show all 9Show fewer
- Posterior placenta.
- History of rupture of membrane.
- Patient refusal or fall outs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome"
Antiphospholipid antibodies are autoantibodies directed against phospholipid-binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)
Read the detailed description
APLS can be primary when no evidence of autoimmune disease is found, or secondary to autoimmune processes like systemic lupus erythematous (SLE) in a 40% of the cases.
- Conditions
- Antiphospholipid Syndrome in Pregnancy
- Being tested
- Ultrasound with Doppler and 3D technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound with Doppler and 3D technologyDiagnostic test
ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology
| Study group | Role | What they receive |
|---|---|---|
| antiphospholipid group | pregnant ladies in the third trimester who have antiphospholipid syndrome Receives: Diagnostic Test: Ultrasound with Doppler and 3D technology | |
| control group | pregnant ladies in the third trimester who have no medical disorders with pregnancy Receives: Diagnostic Test: Ultrasound with Doppler and 3D technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who will have impaired placental doppler indices
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start24 Apr 2018
- Primary completion4 Sep 2020 (estimated)
- Study completion10 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Syndrome in PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505840
- Sponsor's protocol ID
- vocal in placenta
- Status last verified
- Jan 2020
- First submitted
- 13 Apr 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data will be published
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheValue of Placental Vascularization Indices and Placental Volume in Pregnancies With Antiphospholipid Syndrome for Prediction of Neonatal Outcome"
- ClinicalTrials.gov ID
- NCT03505840
- Acronym / sponsor ID
- vocal in placenta
- Conditions
- Antiphospholipid Syndrome in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 4 Sep 2020 (estimated)
- Study completion
- 10 Oct 2020 (estimated)
- First posted
- 23 Apr 2018 (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.
Antiphospholipid antibodies are autoantibodies directed against phospholipid-binding proteins. Among these groups of antibodies, lupus anticoagulant (LA) and anticardiolipin antibodies (aCL)
Detailed description
APLS can be primary when no evidence of autoimmune disease is found, or secondary to autoimmune processes like systemic lupus erythematous (SLE) in a 40% of the cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antiphospholipid group | – | Diagnostic Test: Ultrasound with Doppler and 3D technologypregnant ladies in the third trimester who have antiphospholipid syndrome |
| control group | – | Diagnostic Test: Ultrasound with Doppler and 3D technologypregnant ladies in the third trimester who have no medical disorders with pregnancy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Singleton pregnancy. * Gestational age of 34-37 weeks. * Pregnant women with antiphospholipid syndrome
Key inclusion criteria (3 listed)
- Singleton pregnancy.
Key exclusion criteria (9 listed)
- Twin or multiple pregnancies.
- Congenital fetal anomalies.
- Gestational age of less than 34.
- Gestational age of more than 37.
- Women with placental or umbilical artery anomalies.
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 |
|---|---|---|
| Ultrasound with Doppler and 3D technologyultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology | Diagnostic test | antiphospholipid group, control group |
Primary outcome
The number of participants who will have impaired placental doppler indices
Time frame: within 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No. The research data will be published
Related trials for Antiphospholipid Syndrome in Pregnancy
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
RecruitingPhase 1
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
RecruitingObservational study
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Systemic Lupus Erythematosus, Antiphospholipid Syndrome
RecruitingPhase 2
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
High Risk Pregnancy, Pregnancy Complications
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.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
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 Antiphospholipid Syndrome in Pregnancy, run by Aljazeera Hospital 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 9 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 27 Jan 2020. 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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who will have impaired placental doppler indices (time frame: within 2 months). 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 27 Jan 2020.