Prenatal Care
Conditions
Interventions
This is a randomized, 2-arm, non-blind, non-inferiority clinical trial. A total of 80 participants who meet the eligibility criteria will be probabilistically allocated to one of the groups. The inter
Sponsors
Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Pregnant patients, diagnosed with pre-eclampsia, with indication for the use of magnesium sulfate due to maternal cause, as assessed by the care team; start using magnesium sulfate before delivery, with a schedule for maintaining the medication after delivery
Exclusion criteria
Exclusion criteria: Patient unable to understand the informed consent form, due to cognitive incapacity, definitive or temporary, as a result of pre-eclampsia itself (suspected bleeding in the central nervous system) or due to a cause prior to pregnancy. Patients unable to read the informed consent form (because they are intubated or have clinical or imaging evidence of neurological involvement) will not be invited to participate in this study, as they are considered to be in a vulnerable situation that prevents their participation in this protocol; gestational age is less than 24 weeks; diagnosis of fetal death before delivery (i.e., ultrasound diagnosis of absence of fetal heartbeat upon admission for delivery); presence of multiple pregnancy (more than one fetus); patient with antenatal diagnosis of fetal malformation incompatible with extrauterine life; indication for the use of magnesium sulfate was made exclusively for fetal neuroprotection due to the risk of premature birth, without any maternal clinical indication that would justify its use; magnesium sulfate treatment was suspended before delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repeated use of magnesium sulfate after the end of the first cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of maternal magnesium sulfate intoxication, identified based on: use of calcium gluconate; maternal clinical signs of magnesium sulfate poisoning (reduction in osteotendinous reflexes, reduction in respiratory rate less than 16 inspirations per minute, reduction in heart rate less than 60 heartbeats per minute, lasting more than 30 minutes); serum magnesium dosage;;Assessment of the patient's satisfaction level concerning health care received during hospitalization: assessed through an interview before patient's hospital discharge, on a scale from 0 to 10, in which 0 means very unsatisfied and 10 means very satisfied.;Occurrence of maternal complications, such as: eclampsia; HELLP syndrome; renal failure (increase in creatinine or urea greater than 2 times the admission value); oliguria/anuria (urinary volume less than 15ml/h during the sulfation period); maternal admission to intensive care unit; | — |
Countries
Brazil
Contacts
Public ContactJosé Paulo Guida
Universidade Estadual de Campinas
Outcome results
None listed