Back to resultsHydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Primary Purpose
Recurrent Pregnancy Loss
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Hydroxychloroquine
Hydroxychloroquine placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Pregnancy Loss
Eligibility Criteria
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
Sites / Locations
- RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydroxychlorochine HCQ
Hydroxychlorochine HCQ Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Live birth
Secondary Outcome Measures
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
Birth weight
Gestational age
Admittance to neonatal unit
Immunological status
Measuements of celllur and humoral immunity
Full Information
NCT ID
NCT03305263
First Posted
September 12, 2017
Last Updated
March 11, 2020
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03305263
Brief Title
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Official Title
Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) - et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydroxychlorochine HCQ
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydroxychlorochine HCQ Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Placebo
Intervention Description
One tablet a day from inclusion until end of pregnancy or gestational age 28
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine placebo
Intervention Description
One tablet a day from inclusion until end of pregnancy or gestational age 28
Primary Outcome Measure Information:
Title
Live birth
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
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
Title
Birth weight
Time Frame
At delivery
Title
Gestational age
Time Frame
up to at delivery
Title
Admittance to neonatal unit
Time Frame
Within 28 days of delivery
Title
Immunological status
Description
Measuements of celllur and humoral immunity
Time Frame
Up to two years after end of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henriette Svarre Nielsen, MD, DMSc
Phone
+4535457515
Email
henriette.svarre.nielsen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Lunøe, Nurse
Phone
+4535458486
Email
anne.louise.lunoee@regionh.dk
Facility Information:
Facility Name
Rigshospitalet
City
København
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Lunøe, Nurse
Phone
+4535458486
Email
anne.louise.lunoee@regionh.dk
First Name & Middle Initial & Last Name & Degree
Henriette S Nielsen, MD
Phone
+4535457515
Email
henriette.svarre.nielsen@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
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