NCT03305263

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

3.9 years

First QC Date

September 12, 2017

Last Update Submit

March 11, 2020

Conditions

Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

  • Live birth

    At delivery

Secondary Outcomes (5)

  • 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

  • Admittance to neonatal unit

    Within 28 days of delivery

  • Immunological status

    Up to two years after end of study

Study Arms (2)

Hydroxychlorochine HCQ

EXPERIMENTAL

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.

Drug: Hydroxychloroquine

Hydroxychlorochine HCQ Placebo

PLACEBO COMPARATOR

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.

Drug: Hydroxychloroquine placebo

Interventions

HydroxychloroquineDRUG

One tablet a day from inclusion until end of pregnancy or gestational age 28

Also known as: Placebo
Hydroxychlorochine HCQ
Hydroxychloroquine placeboDRUG

One tablet a day from inclusion until end of pregnancy or gestational age 28

Hydroxychlorochine HCQ Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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
  • Previous treatment with HCQ in pregnancy
  • \>1previous live birth
  • previous participation in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Henriette Svarre Nielsen, MD, DMSc

CONTACT

+4535457515henriette.svarre.nielsen@regionh.dk

Louise Lunøe, Nurse

CONTACT

+4535458486anne.louise.lunoee@regionh.dk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Head of Recurrent Pregnancy Loss Unit, Associate Professor

Study Record Dates

First Submitted

September 12, 2017

First Posted

October 9, 2017

Study Start

January 25, 2018

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

DK(1)