Randomized Controlled Trial of N-Acetylcysteine in the Treatment of Early-Onset Preeclampsia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202603712049354

Enrollment

153

Registered

2026-03-24

Start date

2026-03-16

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Pregnancy and Childbirth

Interventions

N acetylcysteine

Placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant women aged 18 years or older Women diagnosed with early-onset preeclampsia at 24 to 34 weeks’ gestation.

Exclusion criteria

Exclusion criteria: Women who are unwilling to provide informed consent Those with known allergy or hypersensitivity to NAC or any of its components Women on current use of medications or supplements that could interfere with the effects of NAC, such as other antioxidants, nitro-glycerine, activated charcoal, and chloroquine Women receiving a long course of mineral supplements containing NAC during the 6 months before enrolment Women with bleeding disorders Women with bronchial asthma Women with a history of alcohol or drug abuse Women with active liver disease Women with significant chronic renal impairment Women with major fetal anomalies Women with preeclampsia with severe features or eclampsia at the time of randomisation.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the time-to-disease progression (in days) of women with early-onset preeclampsia. Preeclampsia with severe features is the presence of specific clinical features, which may include blood pressure readings consistently elevated to 160/110mmHg or higher; severe proteinuria of 3+ or a urine protein/creatinine ratio of 0.3 or higher; platelet counts less than 100,000/µL; elevated liver enzymes (AST/ALT) or evidence of hepatic dysfunction; serum creatinine level greater than 1.1mg/dL or doubling of baseline creatinine in the absence of other renal diseases; symptoms and signs of pulmonary oedema such as dyspnoea and crackles on lung auscultation; cerebral or visual disturbances such as headaches, visual disturbances, altered mental status, seizures (eclampsia), or other neurological symptoms; and evidence of placental dysfunction such as placental abruption, fetal growth restriction or oligohydramnios on ultrasound examination.	—

Measure

Time frame

The primary outcome measure is the time-to-disease progression (in days) of women with early-onset preeclampsia. Preeclampsia with severe features is the presence of specific clinical features, which may include blood pressure readings consistently elevated to 160/110mmHg or higher; severe proteinuria of 3+ or a urine protein/creatinine ratio of 0.3 or higher; platelet counts less than 100,000/µL; elevated liver enzymes (AST/ALT) or evidence of hepatic dysfunction; serum creatinine level greater than 1.1mg/dL or doubling of baseline creatinine in the absence of other renal diseases; symptoms and signs of pulmonary oedema such as dyspnoea and crackles on lung auscultation; cerebral or visual disturbances such as headaches, visual disturbances, altered mental status, seizures (eclampsia), or other neurological symptoms; and evidence of placental dysfunction such as placental abruption, fetal growth restriction or oligohydramnios on ultrasound examination.

—

Secondary

Measure	Time frame
Safety and treatment tolerability;Maternal outcome (maternal mortality);Composite neonatal outcomes, including as low birth weight in term neonates (baby's birth weight less than 2500g), IUGR, stillbirth, NICU admission, and perinatal and neonatal mortality.	—

Countries

Nigeria

Contacts

Public ContactKehinde Okunade

Professor

kehindeokunade@gmail.com+2348034728139

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Jun 29, 2026