Antiphospholipid Syndrome in PregnancyPhase 4NCT04274803
Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
A Phase 4 study testing Intralipid, 20% Intravenous Emulsion and Conventional therapy of antiphospholipis syndrome in people with Antiphospholipid Syndrome in Pregnancy, run by Tanta University at 1 site in Egypt.
Trial summary
This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Antiphospholipid Syndrome in Pregnancy
- What is being tested?
- Intralipid, 20% Intravenous Emulsion and Conventional therapy of antiphospholipis syndrome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 31 May 2021
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .
Who cannot join
- Patients with gestational age ≥ 9 weeks
- patients with diagnosed other auto-immune disorder
- patients with chronic hypertension, diabetes mellitus, thyroid disorders,
- patient with renal diseases
- patients who requested to withdraw from the study at any point .
Trial locations and contacts
1 site in 1 country.
About this study
This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome
Read the detailed description
This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria.
All women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.
- Conditions
- Antiphospholipid Syndrome in Pregnancy
- Being tested
- Intralipid, 20% Intravenous Emulsion, Conventional therapy of antiphospholipis syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid, 20% Intravenous EmulsionDrug
intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy.
Conventional therapy of antiphospholipis syndromeDrug
the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily.
| Study group | Role | What they receive |
|---|---|---|
| Intralipid group | Experimental | the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. In addition intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy. Receives: Drug: Intralipid, 20% Intravenous Emulsion |
| Standard care group | Active comparator | the patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. Receives: Drug: Conventional therapy of antiphospholipis syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal loss
Fetal demise
Measured: within 9 months
Premature delivery
occurrence of preterm labour before 37 weeks
Measured: Before 37 weeks
Preeclampsia
Hypertesion, proteiuria and or edema
Measured: > 20 weeks
fetal growth restriction
Fetal poderal index less than normal
Measured: within 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Apr 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Why it stopped: no patient enrolled
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.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274803
- Sponsor's protocol ID
- INTRALIPID-APS
- Status last verified
- Jun 2021
- First submitted
- 15 Feb 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: when approved by ethical committee
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
- ClinicalTrials.gov ID
- NCT04274803
- Acronym / sponsor ID
- INTRALIPID-APS
- Conditions
- Antiphospholipid Syndrome in Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 18 Feb 2020 (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.
This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome
Detailed description
This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria.
All women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid group | Experimental | Drug: Intralipid, 20% Intravenous Emulsionthe patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. In addition intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy. |
| Standard care group | Active comparator | Drug: Conventional therapy of antiphospholipis syndromethe patients will receive the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .
Key exclusion criteria (5 listed)
- Patients with gestational age ≥ 9 weeks
- patients with diagnosed other auto-immune disorder
- patients with chronic hypertension, diabetes mellitus, thyroid disorders,
- patient with renal diseases
- patients who requested to withdraw from the study at any point .
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 |
|---|---|---|
| Intralipid, 20% Intravenous Emulsionintralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy. | Drug | Intralipid group |
| Conventional therapy of antiphospholipis syndromethe conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily. | Drug | Standard care group |
Primary outcome
Fetal loss
Time frame: within 9 months
Fetal demise
Premature delivery
Time frame: Before 37 weeks
occurrence of preterm labour before 37 weeks
Preeclampsia
Time frame: > 20 weeks
Hypertesion, proteiuria and or edema
fetal growth restriction
Time frame: within 9 months
Fetal poderal index less than normal
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: Yes. when approved by ethical committee
Related trials for Antiphospholipid Syndrome in Pregnancy
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A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
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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?
A Phase 4 study testing Intralipid, 20% Intravenous Emulsion and Conventional therapy of antiphospholipis syndrome in people with Antiphospholipid Syndrome in Pregnancy, run by Tanta 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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Jun 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fetal loss (time frame: within 9 months). The study lists 4 primary outcomes in all. 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 14 Jun 2021.