Unexplained Recurrent MiscarriageNCT04228263
Hydroxychloroquine and Unexplained Recurrent Miscarriage
A study testing Hydroxychloroquine, Folic Acid and Low-dose aspirin in people with Unexplained Recurrent Miscarriage, run by Assiut University at 1 site in Egypt.
Trial summary
Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Unexplained Recurrent Miscarriage
- 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
- 156 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 8 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
- 1. Women aged between 20- 40 years inclusive. 2. Body Mass Index (BMI) between 18.5 -35 Kg/m2 3. Had at least 2 previous miscarriage before 20 weeks 4. Women willing to conceive. 5. Regular Ovulatory cycles. 6. No anatomical or endocrine cause of recurrent pregnancy loss. 7. Women who have given their informed consent. 8. Negative antibody test for antiphospholipid syndrome (Lupus anticoagulant, Anticardiolipin IgM, IgG, B2glycoprotein) Exclusion criteria
- Women who are already pregnant.
- Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
- Patient already using HCQ
- Patient not get pregnant after 12 months of HCQ use.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. 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
- Unexplained Recurrent Miscarriage
- Being tested
- Hydroxychloroquine, Folic Acid, Low-dose aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400mg
Folic AcidDrug
5 mg
Low-dose aspirinDrug
75 mg
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine group | Other | hydroxychloroquine 400 mg preconceptional Receives: Drug: Hydroxychloroquine; Drug: Folic Acid; Drug: Low-dose aspirin |
| control group | Other | not receive hydroxychloroquine 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 viable fetuses at 20 weeks gestation
Measured: 5 months
Secondary outcomes (5)
Number of patients with miscarriage before 20 weeks
Measured: 5 months
Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)
Measured: 9 months
Number of fetus with Major congenital anmalies
Measured: 9 months
Number of Live birth
Measured: 9 months
Number of Preterm delivery before 37 week gestation.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jan 2020
- Primary completion10 Mar 2023
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained Recurrent MiscarriageStudies 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
- 156 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
- NCT04228263
- Sponsor's protocol ID
- HRP_2020
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine for Improvement of Pregnancy Outcome in Unexplained Recurrent Miscarriage
- ClinicalTrials.gov ID
- NCT04228263
- Acronym / sponsor ID
- HRP_2020
- Conditions
- Unexplained Recurrent Miscarriage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 14 Jan 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.
Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. 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 preconceptional |
| control group | Other | Drug: Folic Acid, Drug: Low-dose aspirinnot receive hydroxychloroquine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Women aged between 20- 40 years inclusive. 2. Body Mass Index (BMI) between 18.5 -35 Kg/m2 3. Had at least 2 previous miscarriage before 20 weeks 4. Women willing to conceive. 5. Regular Ovulatory cycles. 6. No anatomical or endocrine cause of recurrent pregnancy loss. 7. Women who have given their informed consent. 8. Negative antibody test for antiphospholipid syndrome (Lupus anticoagulant, Anticardiolipin IgM, IgG, B2glycoprotein) Exclusion criteria
- Women who are already pregnant.
- Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
- Patient already using HCQ
- Patient not get pregnant after 12 months of HCQ use.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hydroxychloroquine400mg | Drug | hydroxychloroquine group |
| Folic Acid5 mg | Drug | control group, hydroxychloroquine group |
| Low-dose aspirin75 mg | Drug | control group, hydroxychloroquine group |
Primary outcome
Number of viable fetuses at 20 weeks gestation
Time frame: 5 months
5 secondary outcomes
Number of patients with miscarriage before 20 weeks
Time frame: 5 months
Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)
Time frame: 9 months
Number of fetus with Major congenital anmalies
Time frame: 9 months
Number of Live birth
Time frame: 9 months
Number of Preterm delivery before 37 week gestation.
Time frame: 8 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 7 Dec 2023.
- 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?
A study testing Hydroxychloroquine, Folic Acid and Low-dose aspirin in people with Unexplained Recurrent Miscarriage, 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 5 inclusion and 0 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 7 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 viable fetuses at 20 weeks gestation (time frame: 5 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 7 Dec 2023.