NCT04755322

Brief Summary

Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. 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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration 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

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

2.4 years

First QC Date

February 11, 2021

Last Update Submit

December 1, 2023

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • number of cases of preeclampsia

    9 month

Secondary Outcomes (3)

  • number of cases of Number of pregnancy complications such as FGR, IUFD, and gestational hypertension, HELLP syndrome, placental abruption, eclampsia, ICU admission and pulmonary edema

    9 month

  • Number of pregnancies with fetal malformation

    9 months

  • number of live birth

    9 months

Study Arms (2)

hydroxychloroquine group

OTHER

hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg

Drug: HydroxychloroquineDrug: Folic acidDrug: Low-dose aspirin

control group

OTHER

Folic Acid 5 mg+ Low-dose aspirin 75 mg

Drug: Folic acidDrug: Low-dose aspirin

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine 400 mg at start of pregnancy

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 qualify if:

  • Pregnant women in 1st 6 weeks gestation.
  • History of preeclampsia in previous pregnancies.
  • Women who accepted to participate

You may not qualify if:

  • Risk factors (multiple gestation, chronic hypertension, chronic renal disease).
  • Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism
  • Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdel-rahman Mahmoud Mohammed

Asyut, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

HydroxychloroquineFolic AcidAspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

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
Assisstant lecturer

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

March 1, 2021

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

EG(1)