Hydroxychloroquine May be Beneficial for Preeclampsia

NCT06020378 | Active Not Recruiting

• 1 other identifier: IIT-2022-0186
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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).

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Composite morbidity

  Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension

  Gestational period

Secondary Outcomes (3)

• fetal growth restriction

  37 weeks of gestational age

• Preterm delivery

  37 weeks of gestational age

• Abruptio placenta

  37 weeks of gestational age

Study Arms (2)

Hydroxychloroquine treatment group

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

Drug: Hydroxychloroquine

Hydroxychloroquine nontreatment group

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

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine was administered during pregnancy

Also known as: Plaquenil

Hydroxychloroquine treatment group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with RSA who delivered after 28 weeks from November 2016 to August 2022 at Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

You may qualify if:

• singleton pregnant women
• with a history of two or more miscarriages

You may not qualify if:

• 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,
• major malformation of the fetus diagnosed at 11-13 weeks of gestation.
• Known paternal, maternal, or embryo chromosome abnormality;
• Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain RM in the first trimester of pregnancy;
• Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine，Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 31, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

CN (1)