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Hydroxychloroquine in Prevention of Preeclampsia

Primary Purpose

Hydroxychloroquine

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydroxychloroquine
Folic acid
Low-dose aspirin
Placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hydroxychloroquine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Abdel-rahman Mahmoud MohammedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

hydroxychloroquine group

Placebo group

Arm Description

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

Folic Acid 5 mg+ Low-dose aspirin 75 mg+ Placebo oral tablet

Outcomes

Primary Outcome Measures

number of cases of preeclampsia

Secondary Outcome Measures

number of cases of intrauterine growth restriction

Full Information

First Posted
February 11, 2021
Last Updated
July 21, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04755322
Brief Title
Hydroxychloroquine in Prevention of Preeclampsia
Official Title
Hydroxychloroquine is an Immunomodulator for Improvement of Pregnancy Outcomes in Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydroxychloroquine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hydroxychloroquine group
Arm Type
Active Comparator
Arm Description
hydroxychloroquine 400 mg+ Folic Acid 5 mg+ Low-dose aspirin 75 mg
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Folic Acid 5 mg+ Low-dose aspirin 75 mg+ Placebo oral tablet
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
Hydroxychloroquine 400 mg at start of pregnancy
Intervention Type
Drug
Intervention Name(s)
Folic acid
Intervention Description
5 mg
Intervention Type
Drug
Intervention Name(s)
Low-dose aspirin
Intervention Description
75 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
number of cases of preeclampsia
Time Frame
9 month
Secondary Outcome Measure Information:
Title
number of cases of intrauterine growth restriction
Time Frame
8 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdel-rahman Mahmoud Mohammed
Phone
010063784448
Email
abdoelkady4ever@gmail.com
Facility Information:
Facility Name
Abdel-rahman Mahmoud Mohammed
City
Assiut
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Hydroxychloroquine in Prevention of Preeclampsia

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