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OpenTrials
Completed

NCT Number: NCT04755322

Hydroxychloroquine in Prevention of Preeclampsia

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Abdel-rahman Mahmoud Mohammed

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine 400 mg at start of pregnancy

Folic Acid

Drug

5 mg

Low-dose aspirin

Drug

75 mg

Primary outcomes

  1. number of cases of preeclampsia

    Time frame: 9 month

Secondary outcomes

  1. 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

    Time frame: 9 month

  2. Number of pregnancies with fetal malformation

    Time frame: 9 months

  3. number of live birth

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2021
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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