Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Recurrent Pregnancy Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03305263
• Other study ID #: HCQDenmark
• Secondary ID: 2016-004981-24
• Status: Recruiting
• Phase: Phase 3
• Start date: January 25, 2018
• Est. completion date: January 2023

Study information

• Verified date: March 2020
• Source: Rigshospitalet, Denmark
• Contact: Henriette Svarre Nielsen, MD, DMSc
• Phone: +4535457515
• Email: henriette.svarre.nielsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: January 2023
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

1. = 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL

2. = 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss.

Exclusion Criteria:

1. Age below 18 years or above 39 at inclusion

2. Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography

3. Chromosomal abnormalities within the couple

4. Menstrual cycle below 23 days or above 35 days

5. Lupusantikoagulans positivity or immunoglobulin (Ig)G/IgM anticardiolipinantibodies (=10 GPL kU/l at Rigshospitalets Laboratorium) or plasma homocystein =25 mikrogr./l at repeated measurement with 12 weeks interval.

6. HIV or Hepatitis B or C positive

7. Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)

8. Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents

9. Hemoglobin = 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion

10. Previous treatment with HCQ in pregnancy

11. >1previous live birth

12. previous participation in this trial

Related Conditions & MeSH terms

• Abortion, Habitual
• Recurrent Pregnancy Loss

Intervention

Drug:
• Hydroxychloroquine
One tablet a day from inclusion until end of pregnancy or gestational age 28
• Hydroxychloroquine placebo
One tablet a day from inclusion until end of pregnancy or gestational age 28

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth		At delivery
Secondary	Live birth after exclusion of patients with a chromosomal abnormal pregnancy loss, extrauterine pregnancy loss, intended abortion or patients with insufficient intake of study medicine		At delivery
Secondary	Birth weight		At delivery
Secondary	Gestational age		up to at delivery
Secondary	Admittance to neonatal unit		Within 28 days of delivery
Secondary	Immunological status	Measuements of celllur and humoral immunity	Up to two years after end of study