Systemic Lupus ErythematosusNCT03171103
Systemic Lupus and Adverse Pregnancy Outcome
An observational study of Systemic Lupus Erythematosus and Pregnancy Complications, run by Beni-Suef University at 1 site in Egypt.
Trial summary
prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus, Pregnancy Complications
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 1 May 2020
- How long will I take part?
- 3 Years
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All pregnant ladies in Beni-suef localities diagnosed as systemic lupus
Who may be able to join
- all pregnant ladies with settled diagnosis of systemic lupus
- all pregnant ladies who first diagnosed as systemic lupus during current pregnancy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Lupus and Pregnancy Outcome in Benisuef Localities
prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities
- Medical subject headings
- Lupus Erythematosus, Systemic, Pregnancy Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal outcome
Number of patients who have abortion,preterm labor,preeclampsia,eclampsia,accidental hemorrhage,oligohydramnios
Measured: 3 years
Secondary outcomes (1)
fetal outcome
Number of patients who have abortion,prematurity,Intrauterine growth restriction,intrauterine fetal death,still birth,low birth weight,neonatal death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 May 2017
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momen Zakaria Mohammed mohammed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171103
- Sponsor's protocol ID
- 2505
- Status last verified
- May 2017
- First submitted
- 25 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Lupus and Pregnancy Outcome in Benisuef Localities
- ClinicalTrials.gov ID
- NCT03171103
- Acronym / sponsor ID
- 2505
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 31 May 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.
prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All pregnant ladies in Beni-suef localities diagnosed as systemic lupus
Key inclusion criteria (2 listed)
- all pregnant ladies with settled diagnosis of systemic lupus
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
maternal outcome
Time frame: 3 years
Number of patients who have abortion,preterm labor,preeclampsia,eclampsia,accidental hemorrhage,oligohydramnios
1 secondary outcome
fetal outcome
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Lupus Erythematosus and Pregnancy Complications, run by Beni-Suef 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 2 inclusion and 1 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 31 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal outcome (time frame: 3 years). 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 31 May 2017.