Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

March 11, 2020 updated by: Henriette Svarre Nielsen, MD, DMSc, Rigshospitalet, Denmark

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxychlorochine HCQ
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.
One tablet a day from inclusion until end of pregnancy or gestational age 28
Other Names:
  • Placebo
Placebo Comparator: Hydroxychlorochine HCQ 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.
One tablet a day from inclusion until end of pregnancy or gestational age 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth
Time Frame: At delivery
At delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2018

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

October 3, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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