Hydroxychloroquine in Prevention of Preeclampsia

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04755322
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hydroxychloroquine	Drug: Hydroxychloroquine; Drug: Folic acid; Drug: Low-dose aspirin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: hydroxychloroquine group hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg	Drug: Hydroxychloroquine; Hydroxychloroquine 400 mg at start of pregnancy; Drug: Folic acid; 5 mg; Drug: Low-dose aspirin; 75 mg
Placebo Comparator: Placebo group Folic Acid 5 mg+ Low-dose aspirin 75 mg+ Placebo oral tablet	Drug: Folic acid; 5 mg; Drug: Low-dose aspirin; 75 mg; Drug: Placebo; oral tablets

Outcome Measures

Primary Outcome Measures

1. number of cases of preeclampsia [9 month]

Secondary Outcome Measures

1. number of cases of intrauterine growth restriction [8 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women in 1st 6 weeks gestation.

• Women willing to participate.

Exclusion Criteria:

• Known contraindication to treatment by Hydroxychloroquine (

• Patients already using Hydroxychloroquine

• Impossible to follow-up.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abdel-rahman Mahmoud Mohammed	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdelrahman Mahmoud Mohammed, Assisstant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT04755322
• Other Study ID Numbers: HPP_2020
• First Posted: Feb 16, 2021
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pre-Eclampsia; Aspirin; Folic Acid; Hydroxychloroquine

Study Results

No Results Posted as of Jul 23, 2021