Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Phase 3

• Conditions: Recurrent Pregnancy Loss
• Interventions: Drug: Hydroxychloroquine placebo; Drug: Hydroxychloroquine

• Registration Number: NCT03305263
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Study Start: 2018-01-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12
• Primary Completion: 2022-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydroxychlorochine HCQ Placebo	Hydroxychloroquine placebo	Women in the experimental arm will take 200 mg HCQ placebo tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
Hydroxychlorochine HCQ	Hydroxychloroquine	Women in the experimental arm will take 200 mg HCQ tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.

Primary Outcome Measures

Name	Time	Method
Live birth	At delivery

Secondary Outcome Measures

Name	Time	Method
Admittance to neonatal unit	Within 28 days of delivery
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
Birth weight	At delivery
Gestational age	up to at delivery
Immunological status	Up to two years after end of study	Measuements of celllur and humoral immunity

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 København, Denmark