PreeclampsiaNCT04755322
Hydroxychloroquine in Prevention of Preeclampsia
A study testing Hydroxychloroquine, Folic acid and Low-dose aspirin in people with Preeclampsia, run by Assiut University at 1 site in Egypt.
Trial summary
Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Hydroxychloroquine, Folic acid and Low-dose aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 Jul 2023
- Phase
- Interventional
- 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 in 1st 6 weeks gestation.
- History of preeclampsia in previous pregnancies.
- Women who accepted to participate
Who cannot join
- Risk factors (multiple gestation, chronic hypertension, chronic renal disease).
- Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism
- Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia
Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.
- Conditions
- Preeclampsia
- Being tested
- Hydroxychloroquine, Folic acid, Low-dose aspirin
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 400 mg at start of pregnancy
Folic acidDrug
5 mg
Low-dose aspirinDrug
75 mg
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine group | Other | hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg Receives: Drug: Hydroxychloroquine; Drug: Folic acid; Drug: Low-dose aspirin |
| control group | Other | Folic Acid 5 mg+ Low-dose aspirin 75 mg Receives: Drug: Folic acid; Drug: Low-dose aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cases of preeclampsia
Measured: 9 month
Secondary outcomes (3)
number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema
Measured: 9 month
Number of pregnancies with fetal malformation
Measured: 9 months
number of live birth
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Mar 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
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.
- More trials run by Assiut 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mahmoud Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755322
- Sponsor's protocol ID
- HPP_2020
- Status last verified
- Dec 2023
- First submitted
- 11 Feb 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia
- ClinicalTrials.gov ID
- NCT04755322
- Acronym / sponsor ID
- HPP_2020
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 16 Feb 2021 (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.
Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroxychloroquine group | Other | Drug: Hydroxychloroquine, Drug: Folic acid, Drug: Low-dose aspirinhydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg |
| control group | Other | Drug: Folic acid, Drug: Low-dose aspirinFolic Acid 5 mg+ Low-dose aspirin 75 mg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women in 1st 6 weeks gestation.
- History of preeclampsia in previous pregnancies.
- Women who accepted to participate
Key exclusion criteria (3 listed)
- Risk factors (multiple gestation, chronic hypertension, chronic renal disease).
- Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism
- Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up
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 |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 400 mg at start of pregnancy | Drug | hydroxychloroquine group |
| Folic acid5 mg | Drug | control group, hydroxychloroquine group |
| Low-dose aspirin75 mg | Drug | control group, hydroxychloroquine group |
Primary outcome
number of cases of preeclampsia
Time frame: 9 month
3 secondary outcomes
number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema
Time frame: 9 month
Number of pregnancies with fetal malformation
Time frame: 9 months
number of live birth
Time frame: 9 months
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 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Preeclampsia
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.
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 study testing Hydroxychloroquine, Folic acid and Low-dose aspirin in people with Preeclampsia, run by Assiut 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 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 8 Dec 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?
number of cases of preeclampsia (time frame: 9 month). 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 8 Dec 2023.