PreeclampsiaNCT02699437
Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
An observational study of Preeclampsia, run by Mohamed Sayed Abdelhafez at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Testing for antiphospholipid antibodies
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department
Who may be able to join
- Pregnant women with preeclampsia.
Who cannot join
- Women with systemic autoimmune disease.
- Women with active thromboembolic disorders.
- Women with history of previous thromboembolic disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes
Read the detailed description
For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.
- Conditions
- Preeclampsia
- Being tested
- Testing for antiphospholipid antibodies
- Keywords
- Preeclampsia, Antiphospholipid 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.
Testing for antiphospholipid antibodiesOther
Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with preeclampsia | Testing for antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) will be performed in pregnant women with preeclampsia. Receives: Other: Testing for antiphospholipid antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive antiphospholipid antibodies
Number of women having positive antiphospholipid antibodies per total number of women
Measured: 20 weeks to 42 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Hanaa M El-Shafiey, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura UniversityAlaa El-Din M El-Gohary, Dr, Study director, Mansoura UniversityEl-Said M Abd El-Hady, Prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699437
- Sponsor's protocol ID
- HME
- Status last verified
- Oct 2023
- First submitted
- 26 Feb 2016
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT02699437
- Acronym / sponsor ID
- HME
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Antiphospholipid Antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 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 purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes
Detailed description
For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with preeclampsia | – | Other: Testing for antiphospholipid antibodiesTesting for antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant) will be performed in pregnant women with preeclampsia. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Attendants of Tertiary Hospital Obstetric Outpateint Clinics and Emergency Department
Key inclusion criteria (1 listed)
- Pregnant women with preeclampsia.
Key exclusion criteria (3 listed)
- Women with systemic autoimmune disease.
- Women with active thromboembolic disorders.
- Women with history of previous thromboembolic 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 |
|---|---|---|
| Testing for antiphospholipid antibodiesBlood samples will be tested for anticardiolipin antibodies and lupus anticoagulant | Other | Pregnant women with preeclampsia |
Primary outcome
Rate of positive antiphospholipid antibodies
Time frame: 20 weeks to 42 weeks gestational age
Number of women having positive antiphospholipid antibodies per total number of women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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
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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.
Hanaa M El-Shafiey principal investigator
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
Alaa El-Din M El-Gohary, Dr study director
Mansoura University
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 Preeclampsia, run by Mohamed Sayed Abdelhafez 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 30 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of positive antiphospholipid antibodies (time frame: 20 weeks to 42 weeks gestational age). 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 30 Oct 2023.