Hydroxychloroquine in Prevention of Preeclampsia

Preeclampsia Clinical Trial

Official title:

Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755322
• Other study ID #: HPP_2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: December 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Pregnant women in 1st 6 weeks gestation.

2. History of preeclampsia in previous pregnancies.

3. Women who accepted to participate

Exclusion Criteria:

1. Risk factors (multiple gestation, chronic hypertension, chronic renal disease).

2. 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

3. Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine 400 mg at start of pregnancy
• Folic acid
5 mg
• Low-dose aspirin
75 mg

Locations

Country	Name	City	State
Egypt	Abdel-rahman Mahmoud Mohammed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of cases of preeclampsia		9 month
Secondary	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
Secondary	Number of pregnancies with fetal malformation		9 months
Secondary	number of live birth		9 months