Hydroxychloroquine May be Beneficial for Preeclampsia

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06020378
Collaborator
(none)
359
12

Study Details

Study Description

Brief Summary

The purpose of this research is to investigate the impact of hydroxychloroquine on the incidence of hypertensive pregnancy disorders in women with a history of recurrent spontaneous abortion (RSA).

Condition or Disease Intervention/Treatment Phase

Detailed Description

Preeclampsia affects about 3-5% of all pregnancies and is estimated to cause at least 42 000 maternal deaths annually, remaining an important cause of death and complications for the mother and baby. However, no treatment yet has been found that affects disease progression except for termination of pregnancy which may cause iatrogenic preterm labor. Therefore, keenly sought for approaches to improving clinical outcomes in pre-eclampsia would be needed.

Hydroxychloroquine (HCQ), an antimalarial drug, is commonly used in the treatment of pregnant women with RSA and has proven to be safe for both the mother and the fetus. Because of the antioxidant effect, anti-inflammatory effect, and vasculoprotective effect of HCQ, it has been thought to be beneficial in the prevention of preeclampsia.

Therefore, we conducted a retrospective cohort study to evaluate the impact of HCQ treatment on the prevention of preeclampsia in RSA pregnancies.

Study Design

Study Type:
Observational
Anticipated Enrollment :
359 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Hydroxychloroquine treatment group

The Hydroxychloroquine treatment group was defined as having exposure to Hydroxychloroquine during pregnancy.

Drug: Hydroxychloroquine
Hydroxychloroquine was administered during pregnancy
Other Names:
  • Plaquenil
  • Hydroxychloroquine nontreatment group

    The Hydroxychloroquine nontreatment group was defined as having no exposure to Hydroxychloroquine during pregnancy.

    Outcome Measures

    Primary Outcome Measures

    1. Composite morbidity [Gestational period]

      Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension

    Secondary Outcome Measures

    1. fetal growth restriction [37 weeks of gestational age]

      <10th percentile for gestational age

    2. Preterm delivery [37 weeks of gestational age]

      Delivery before 37 weeks

    3. Abruptio placenta [37 weeks of gestational age]

      The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. singleton pregnant women

    2. with a history of two or more miscarriages

    Exclusion Criteria:
    1. indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, malignancy,

    2. major malformation of the fetus diagnosed at 11-13 weeks of gestation.

    3. Known paternal, maternal, or embryo chromosome abnormality;

    4. Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain RM in the first trimester of pregnancy;

    5. Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT06020378
    Other Study ID Numbers:
    • IIT-2022-0186
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    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:

    Study Results

    No Results Posted as of Aug 31, 2023