Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

STATUS

Recruiting
End date

Jan 24, 2023
participants needed

186
sponsor

Rigshospitalet, Denmark

Updated on 1 March 2022

See if I qualify

malaria

discoid lupus erythematosus

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.

Details

Condition	Recurrent Pregnancy Loss
Treatment	hydroxychloroquine, Hydroxychloroquine Placebo
Clinical Study Identifier	NCT03305263
Sponsor	Rigshospitalet, Denmark
Last Modified on	1 March 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL
	3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss
Exclusion Criteria
	Age below 18 years or above 39 at inclusion
	Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography
	Chromosomal abnormalities within the couple
	Menstrual cycle below 23 days or above 35 days
	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
	HIV or Hepatitis B or C positive
	Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)
	Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents
	Hemoglobin 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion
	Previous treatment with HCQ in pregnancy
	>1previous live birth
	previous participation in this trial

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

malaria

discoid lupus erythematosus

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss