A Phase 3 interventional study of Hydroxychloroquine and Placebo in Recurrent Miscarriage and First Trimester Abortion, sponsored by University Hospital, Brest. Active, not recruiting at 18 sites in France. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment
Recurrent miscarriage (RM) defined by >=3 consecutive losses affects 1% of fertile couples. Most women have recurrent early loss with a failure of development before 10 weeks' gestation. Standard investigations fail to reveal any apparent cause in >50% of couples.
No study has demonstrated any benefit of any medication in women with Unexplained RM, in the presence or absence of an inherited thrombophilia.
Moreover, the benefit of aspirin and/or heparin has not been proved in women with Antiphospholipid (APL) antibody without other clinical manifestations of Antiphospholipid Syndrome.
Hydroxychloroquine (HQ) is a molecule whose properties (anti-thrombotic, vascular-protective, immunomodulatory, improved glucose tolerance, lipid-lowering, anti-infectious) could be useful against mechanisms of Unexplained RM.
There is no data concerning the benefit of HQ in RM in the presence or absence of antiphospholipid antibodies or any inherited thrombophilia.
Administration in (Systemic Lupus erythematosus (SLE) women and for Malaria prevention provides extensive safety data during pregnancy.
Oral administration makes possible treatment since the preconception period. For all of that and its low cost, hydroxychloroquine should be evaluated in RM whatever the woman thrombophilic status.
Regarding the mechanisms of unexplained RM, on the basis of animal models and clinical studies, many hypotheses were raised:
Except psychological support, there is no treatment whose benefit has been proved in unexplained RM, in the presence or in the absence of an inherited thrombophilia. Moreover the absence of benefit of some treatments has been clearly demonstrated. Although the prognostic is not so poor (live-birth rates around 70%), proposed therapeutic interventions are sometimes excessive (regarding possible side effects and cost): as intravenous immunoglobulins, assisted procreation ...anti-TNF.
Consequently, for the management of these distressed patients, investigating other therapeutic options is highly needed.
Regarding recurrent miscarriage in women with high titers of antiphospholipid but without any other previous clinical event listed in the antiphospholipid syndrome, the benefit of antithrombotic treatment remains controversial (negative results of the HepASA trial) and hydroxychloroquine has never been assessed, although retrospective studies are encouraging.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's planned enrollment of 300 is above the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment will be orally administrated, at a daily dose of 400 mg of hydroxychloroquine . The treatment will be started before conception and will be stopped at the end of the tenth week of gestation or before in case of pregnancy loss.
Drug: Hydroxychloroquine
A similar placebo will be orally administrated every day.
Drug: Placebo
Hydroxychloroquine : 200 mg twice a day
placebo of hydroxychloroquine
A live and viable birth
In case of preterm and/or low birth weight, we define the viability by the decision to transfer the newborn to a neonatal intensive care unit
Time frame: At delivery
a live and viable birth (for the subgroup analyses)
Time frame: At delivery
occurrence of pregnancy complications (Recurrent Miscarriage-any other premature termination of pregnancy-placental vascular disease)
Time frame: Since the beginning of pregnancy up to delivery
gestation time (in weeks of amenorrhea) at delivery,
Time frame: At delivery up
birth weight (in grams) at delivery
Time frame: At delivery
survival of the newborn
Time frame: At 28 days of the newborn
psychomotor development of the child (normal/abnormal)
Time frame: at 6 months of age
psychomotor development of the child (normal/abnormal)
Time frame: at 12 months of age
height (in centimeters)
Time frame: at 6 months of age
height (in centimeters)
Time frame: at 12 months of age
weight (in grams)
Time frame: at 6 months of age
weight (in grams)
Time frame: at 12 months of age
Cranial perimeter (in centimeters)
Time frame: at 6 months of age
Cranial perimeter (in centimeters)
Time frame: at 12 months of age
Plan to share: No
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University Hospital, Brest