Hydroxychloroquine May be Beneficial for Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:

Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06020378
• Other study ID #: IIT-2022-0186
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 359
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine was administered during pregnancy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite morbidity	Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension	Gestational period
Secondary	fetal growth restriction	<10th percentile for gestational age	37 weeks of gestational age
Secondary	Preterm delivery	Delivery before 37 weeks	37 weeks of gestational age
Secondary	Abruptio placenta	The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy	37 weeks of gestational age