NCT04228263

Brief Summary

Recurrent miscarriage affects women of childbearing age worldwide. Vascular endothelial dysfunction and immunological impairment are associated with recurrent miscarriage To date, there is no effective or optimal therapeutic approach for these condition. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2023

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

January 11, 2020

Last Update Submit

December 1, 2023

Conditions

Unexplained Recurrent Miscarriage

Outcome Measures

Primary Outcomes (1)

  • Number of viable fetuses at 20 weeks gestation

    5 months

Secondary Outcomes (5)

  • Number of patients with miscarriage before 20 weeks

    5 months

  • Number of pregnancy complications such as ( FGR or preeclampsia, IUFD after 20 week gestation)

    9 months

  • Number of fetus with Major congenital anmalies

    9 months

  • Number of Live birth

    9 months

  • Number of Preterm delivery before 37 week gestation.

    8 months

Study Arms (2)

hydroxychloroquine group

OTHER

hydroxychloroquine 400 mg preconceptional

Drug: HydroxychloroquineDrug: Folic AcidDrug: Low-dose aspirin

control group

OTHER

not receive hydroxychloroquine

Drug: Folic AcidDrug: Low-dose aspirin

Interventions

HydroxychloroquineDRUG

400mg

hydroxychloroquine group
Folic AcidDRUG

5 mg

control grouphydroxychloroquine group
Low-dose aspirinDRUG

75 mg

control grouphydroxychloroquine group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Women who are already pregnant.
  • Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, acute intermittent porphyria, chronic liver or kidney insufficiency, extensive cutaneous psoriasis not controlled by local treatment, significant chronic digestive , hematologic disease epilepsy or psychotic disorders.) or known rare disorder of lactose metabolism .
  • Patient already using HCQ
  • Patient not get pregnant after 12 months of HCQ use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdel-rahman Mahmoud Mohammed

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

HydroxychloroquineFolic AcidAspirin

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPterinsPteridinesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 14, 2020

Study Start

January 1, 2020

Primary Completion

March 10, 2023

Study Completion

July 8, 2023

Last Updated

December 7, 2023

Record last verified: 2023-12

Locations

EG(1)