Evaluation of the Effect Of Sulfasalazine on Preeclampsia

Evaluation of the Effect Of Sulfasalazine on Maternal and Neonatal Outcomes in Pregnant Women with a History of Any Type of Hypertension or Fetal Growth Restriction (Randomized Clinical Trial).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250708066406N1

Enrollment

128

Registered

2025-07-18

Start date

2025-08-14

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Preeclampsia. Pre-eclampsia

Interventions

Intervention 1: Intervention group: Participants in the intervention group receive 80 mg of aspirin daily combined with 500 mg of sulfasalazine starting from 12–20 weeks of gestation. Both drugs are a

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant mothers aged 18-45 years. Gestational age between 12 and 20 weeks. Pregnant mothers with a history of any type of pregnancy-induced hypertension. Pregnant mothers with a history of previous FGR(Fetal Growth Restriction).

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to sulfasalazine. Currently taking medications that interact with sulfasalazine. Abnormal karyotype detected in CVS or amniocentesis. Major anomaly detected in the anomaly scan.

Design outcomes

Primary

Measure	Time frame
Incidence of preeclampsia during pregnancy. Timepoint: During all scheduled prenatal visits (every 4 weeks until 28 weeks, every 2 weeks until 36 weeks, and weekly until delivery), and in case of warning signs. Method of measurement: Blood pressure measurement by calibrated digital sphygmomanometer; 24-hour urine protein; CBC; liver enzymes; clinical evaluation of symptoms.;Occurrence of intrauterine growth restriction (IUGR). Timepoint: Every 3–4 weeks starting from 26 weeks of gestation until delivery. Method of measurement: Fetal growth ultrasound performed by a radiologist using standardized equipment; biometric data recorded in study forms.;Abnormal maternal weight gain (>2 kg in one week). Timepoint: At each routine prenatal visit from week 12 until delivery (every 4 weeks, every 2 weeks, then weekly). Method of measurement: Weighing with a digital calibrated scale in the clinic; data recorded in pregnancy visit forms.	—

Measure

Time frame

Incidence of preeclampsia during pregnancy. Timepoint: During all scheduled prenatal visits (every 4 weeks until 28 weeks, every 2 weeks until 36 weeks, and weekly until delivery), and in case of warning signs. Method of measurement: Blood pressure measurement by calibrated digital sphygmomanometer; 24-hour urine protein; CBC; liver enzymes; clinical evaluation of symptoms.;Occurrence of intrauterine growth restriction (IUGR). Timepoint: Every 3–4 weeks starting from 26 weeks of gestation until delivery. Method of measurement: Fetal growth ultrasound performed by a radiologist using standardized equipment; biometric data recorded in study forms.;Abnormal maternal weight gain (>2 kg in one week). Timepoint: At each routine prenatal visit from week 12 until delivery (every 4 weeks, every 2 weeks, then weekly). Method of measurement: Weighing with a digital calibrated scale in the clinic; data recorded in pregnancy visit forms.

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Secondary

Measure	Time frame
Maternal systolic blood pressure during pregnancy. Timepoint: At every routine visit (every 4 weeks until 28 weeks, every 2 weeks until 36 weeks, then weekly until delivery). Method of measurement: Digital sphygmomanometer in sitting position after 5 minutes of rest.;Incidence of warning signs of preeclampsia(headache, visual disturbances, epigastric pain, edema, sudden weight gain, and other clinical signs suspicious for preeclampsia). Timepoint: At each routine visit or emergency referral. Method of measurement: Clinical assessment and documentation using standardized checklist by a physician.;24-hour urine protein level in symptomatic participants. Timepoint: Whenever warning signs occur. Method of measurement: 24-hour urine collection and laboratory quantification (mg/24hr).;Gestational age at delivery. Timepoint: At the time of delivery. Method of measurement: Gestational age in weeks calculated based on last menstrual period (LMP) or early ultrasound.;Neonatal birth weight. Timepoint: Immediately after delivery. Method of measurement: Weight measurement using a precise digital neonatal scale.	—

Measure

Time frame

Maternal systolic blood pressure during pregnancy. Timepoint: At every routine visit (every 4 weeks until 28 weeks, every 2 weeks until 36 weeks, then weekly until delivery). Method of measurement: Digital sphygmomanometer in sitting position after 5 minutes of rest.;Incidence of warning signs of preeclampsia(headache, visual disturbances, epigastric pain, edema, sudden weight gain, and other clinical signs suspicious for preeclampsia). Timepoint: At each routine visit or emergency referral. Method of measurement: Clinical assessment and documentation using standardized checklist by a physician.;24-hour urine protein level in symptomatic participants. Timepoint: Whenever warning signs occur. Method of measurement: 24-hour urine collection and laboratory quantification (mg/24hr).;Gestational age at delivery. Timepoint: At the time of delivery. Method of measurement: Gestational age in weeks calculated based on last menstrual period (LMP) or early ultrasound.;Neonatal birth weight. Timepoint: Immediately after delivery. Method of measurement: Weight measurement using a precise digital neonatal scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Gholami

Yasouj University of Medical Sciences

gholami.368z@gmail.com+98 71 3872 5010

Outcome results

None listed

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