NCT03305263

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) - et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious). There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy. This study has the potential to establish support for a new treatment option for unexplained RPL.

Conditions

• Recurrent Pregnancy Loss

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	One tablet a day from inclusion until end of pregnancy or gestational age 28
DRUG	Hydroxychloroquine placebo	One tablet a day from inclusion until end of pregnancy or gestational age 28

Timeline

• Start date: 2018-01-25
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2017-10-09
• Last updated: 2020-03-12

Locations

1 site across 1 country: Denmark