Magnesium sulphate in continuous administration compare to discontinuous administration in the expectant management of severe preeclampsia: randomized controlled trial

Sulfato de magnesio en pauta continua versus discontinua en la conducta expectante de la preeclampsia grave: ensayo clínico aleatorizado

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002095-17-ES

Enrollment

Unknown

Registered

2011-07-19

Start date

2011-09-13

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Preeclampsia grave MedDRA version: 14.0 Level: LLT Classification code 10040445 Term: Severe pre-eclampsia, antepartum System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions

Interventions

Trade Name: Sulfate de Magnesium Lavoisier Product Name: Magnesium sulfate Pharmaceutical Form: Solution for infusion INN or Proposed INN: Magnesium sulphate CAS Number: 7487-88-9 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Pregnant women of 24.0 - 33.6 weeks with severe preeclampsia after 24 h of treatment with intravenous magnesium sulfate (4 g bolus followed by continuous infusion pump 1 g / h). They include multiple pregnancies, HELLP syndrome, oligohydramnios, intrauterine growth retardation (IUGR) and patients with associated medical conditions who don't meet the exclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Eclampsia, uncontrolled blood pressure at maximum doses of two antihypertensive drugs, acute pulmonary edema, abruptio placenta, fetal death on admission, suspected fetal welfare loss. Patients with myasthenia gravis, myocardial involvement or cardiac conduction defects

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether continuous administration of magnesium sulfate prolongs pregnancy more days compared to discontinuous administration;Secondary Objective: 1. To evaluate and compare the incidence of maternal complications according to treatment regimen: death, eclampsia, placental abruption usually inserted (abruptio placentae), hemorrhage, acute pulmonary edema, acute renal failure, cerebral edema. 2. To evaluate and compare the incidence of fetal complications (death, cerebral palsy, intraventricular hemorrhage, respiratory distress, persistent patent ductus arteriosus refractory to medical treatment). 3. To evaluate fetal hemodynamic evolution and its association with perinatal outcomes according to the prescription given. 4. To evaluate the prognostic role of angiogenic factors in the expectant management of severe preeclampsia;Primary end point(s): Days after inclusion in the study until delivery;Timepoint(s) of evaluation of this end point: Daily control	—

Measure

Time frame

Main Objective: To determine whether continuous administration of magnesium sulfate prolongs pregnancy more days compared to discontinuous administration;Secondary Objective: 1. To evaluate and compare the incidence of maternal complications according to treatment regimen: death, eclampsia, placental abruption usually inserted (abruptio placentae), hemorrhage, acute pulmonary edema, acute renal failure, cerebral edema. 2. To evaluate and compare the incidence of fetal complications (death, cerebral palsy, intraventricular hemorrhage, respiratory distress, persistent patent ductus arteriosus refractory to medical treatment). 3. To evaluate fetal hemodynamic evolution and its association with perinatal outcomes according to the prescription given. 4. To evaluate the prognostic role of angiogenic factors in the expectant management of severe preeclampsia;Primary end point(s): Days after inclusion in the study until delivery;Timepoint(s) of evaluation of this end point: Daily control

—

Secondary

Measure	Time frame
Secondary end point(s): Maternal complications: Placental abruption Acute pulmonary edema Eclampsia Renal insufficiency ICU admission Fetal/neonatal complications: Intrauterine death Perinatal death Intraventricular hemorrhage Respiratory Distress Retinopathy of prematurity Neonatal sepsis;Timepoint(s) of evaluation of this end point: Daily control	—

Countries

Spain

Contacts

Public ContactAnna Suy Franch

Anna Suy Franch

asuy@vhebron.net349327490254954

Outcome results

None listed

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