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The effect of hydroxychloroquine ?n placental insufficiency

The effect of hydroxychloroquine ?n maternal and fetal outcomes in pregnant women with history of placental insufficiency

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250323065146N1
Enrollment
108
Registered
2025-10-26
Start date
2025-09-21
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

placental insufficiency. Maternal care for known or suspected placental insufficiency, third trimester

Interventions

Intervention 1: Control group: In this group, mothers receive low-dose aspirin, 160 mg daily, from 12 to 36 weeks of pregnancy, according to national and international protocols, due to a history of o

Sponsors

Yasouj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: single tone pregnancy past history of placental insufficiency no allergic reaction to Hydroxychloroquine no recent use of Hydroxychloroquine no retinopathy in mothers older than 40 y/o

Exclusion criteria

Exclusion criteria: past history of autoimmune and rheumatoid disease past history of hypertension or diabetes

Design outcomes

Primary

MeasureTime frame
Birth weight. Timepoint: Immediately after birth. Method of measurement: hospital scale.

Secondary

MeasureTime frame
NICU Admission. Timepoint: Immediately after birth until discharge. Method of measurement: Hospital records and NICU records.;Preeclampsia. Timepoint: Initially, at the first prenatal visit before 12 weeks and before the start of the intervention, and then every 4 weeks until week 28, every 2 weeks from 28 to 36 weeks, and weekly from 36 weeks until delivery, and an assessment is made at each visit. Method of measurement: Mercury or digital sphygmomanometer, dipstick urine test, 24-hour proteinuria, clinical symptom checklist.;Gestational hypertension. Timepoint: Initially, at the first prenatal visit before 12 weeks and before the start of the intervention, and then every 4 weeks until week 28, every 2 weeks from 28 to 36 weeks, and weekly from 36 weeks until delivery, and an assessment is made at each visit. Method of measurement: Mercury or digital sphygmomanometer, recorded in maternal record.;Placental abruption. Timepoint: Initially, at the first prenatal visit before 12 weeks and before the start of the intervention, and then every 4 weeks until week 28, every 2 weeks from 28 to 36 weeks, and weekly from 36 weeks until delivery, and an assessment is made at each visit. Method of measurement: Ultrasound, patient record, clinical examination based on American College of Obstetricians and Gynecologists criteria.;Intrauterine growth restriction. Timepoint: From the 20th week of pregnancy (8 weeks after the start of the intervention) every 2 to 4 weeks until delivery. Method of measurement: Ultrasound, maternal medical record, standard fetal growth curves based on ACOG criteria.;Preterm labor. Timepoint: From the 20th week of pregnancy (8 weeks after the start of the intervention) every 2 to 4 weeks until delivery. Method of measurement: Maternal medical record and study registration.;APGAR score at 1 and 5 minute. Timepoint: 1 and 5 minutes after birth. Method of measurement: Standard APGAR form.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRazie Vanda

Yasouj University of Medical Sciences

ra.vanda@yahoo.com+98 74 3334 6070

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026