The STEP-Mag Trial

Phase 3

• Conditions: Pregnancy and Childbirth; Preeclampsia

• Registration Number: PACTR202112816270738
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 12000

Inclusion Criteria

To be eligible for inclusion into this trial, the women must fulfill all of the following criteria:

1.Be admitted with a diagnosis of pre-eclampsia and with clinical or laboratory indication(s) for magnesium sulfate treatment, as defined by any of the following: two readings of systolic blood pressure =160 mm Hg, or diastolic blood pressure =110 mm Hg along with =2+ proteinuria on urine dipstick; or the presence of symptoms, signs or laboratory findings suggestive of severe disease such as headache, visual disturbances, upper abdominal pain, pulmonary oedema, nausea and vomiting, hyperreflexia or clonus, elevated liver enzymes, raised serum creatinine, or thrombocytopenia. Women with HELLP syndrome, a severe form of pre-eclampsia characterized by Haemolysis, Elevated Liver enzymes, and Low Platelets (<100 cells/mcl) will be included if there is no clinical contraindication to IM injection.
2.Have not yet given birth but birth is planned or expected within the next 24 hours, or have given birth within the last 24 hours.
3.Provide written informed consent before any trial-related procedures are carried out.

Exclusion Criteria

Women are not eligible if they fulfill any of the following exclusion criteria:

1.Unable or unwilling to give informed consent (because the woman is too distressed or not capable to understand, confirm and give informed consent due to emergency or health condition, or does not wish to be randomized for whatever reason).
2.Are non-emancipated minors (as per local regulations) without a guardian.
3.History of hypersensitivity to magnesium sulfate.
4.Serious cardiovascular disorders (WHO classification III or IV or acute heart failure).
5.Serious hepatic (encephalopathy or coma) or renal disease.
6.History of epilepsy.
7.Myasthenia gravis or any muscular dystrophies.
8.Coagulopathy.
9.Have previously received magnesium sulfate for eclampsia prevention in the current pregnancy.
10.Planned to receive magnesium sulfate regimen other than the regimens specified for the trial on account of other medical indication(s) (e.g. fetal neuroprotection).
11.Known oliguria (<400mL urine in 24 hours) at the time of admission.

Study & Design

• Study Type: Interventional
• Study Design: Not specified