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Withdrawn study: could hydroxychloroquine help High-Risk pregnancies?

NCT ID NCT04275778

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to see if adding hydroxychloroquine to standard treatment (aspirin and heparin) could help women with antiphospholipid syndrome have a healthy full-term pregnancy. It planned to enroll pregnant women before 14 weeks of gestation. However, the trial was withdrawn before any participants were enrolled, so no conclusions can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxychloroquine
What this could lead to
If it had succeeded, this could have pointed toward a way to improve the chance of a healthy full-term pregnancy for women with antiphospholipid syndrome.
What could go wrong
The trial was withdrawn before enrolling anyone, so no results are available. Even if conducted, the benefit of adding hydroxychloroquine was uncertain and the study was small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Jul 2021

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 48 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \>18 years * Spontaneous consecutive pregnancy ongoing before the 14th week of gestation \-- SAPL obstetrics (modified Sapporo criteria = Sydney criteria) with fetal death ≥10 weeks of gestation without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity \<34SA with placental insufficiency (with or without thrombotic SAPL) * Signed informed consent Exclusion Criteria: * Other SAPL subgroups: early isolated miscarriages \<10 weeks * Contraindication to hydroxychloroquine: * retinopathy, * hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients especially lactose * Associated systemic lupus, associated Sjogren syndrome * Treatment with hydroxychloroquine in progress * Patient under guardianship or curatorship * Patient deprived of liberty * Lack of Social Insurance

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome primary antiphospholipid syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anticoagulants Antiphospholipid syndrome in pregnancy

Contacts and locations

Locations

  • Hopital Saint Antoine

    Paris, 75012, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.