NCT01408979

Brief Summary

Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

August 2, 2011

Last Update Submit

August 20, 2012

Conditions

Severe Preeclampsia

Keywords

Severe preeclampsiamagnesium sulfateanticonvulsivant

Outcome Measures

Primary Outcomes (1)

  • Need to continue therapy for another 12 hours.

    Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.

    24 hours

Secondary Outcomes (1)

  • Satisfaction

    24 hours

Study Arms (2)

12 hours of magnesium sulfate

EXPERIMENTAL

Patients in this group will have magnesium sulfate administered for 12 hours after delivery

Drug: Magnesium sulfate 12 hours

24 hours of magnesium sulfate

ACTIVE COMPARATOR

Patients in this group will have magnesium sulfate administered for 24 hours after delivery

Drug: Magnesium sulfate 24 hours

Interventions

Magnesium sulfate 12 hoursDRUG

Magnesium sulfate, 1g/h, (10% solution), for 12 hours

12 hours of magnesium sulfate
Magnesium sulfate 24 hoursDRUG

Magnesium sulfate, 1g/h, (10% solution), for 24 hours

24 hours of magnesium sulfate

Eligibility Criteria

Age11 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pre-eclampsia;
  • Puerperium.

You may not qualify if:

  • Associated maternal diseases;
  • Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
  • Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMIP

Recife, Pernambuco, 50.000, Brazil

Location

Related Publications (2)

  • Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

    PMID: 37815037DERIVED

  • Maia SB, Katz L, Neto CN, Caiado BV, Azevedo AP, Amorim MM. Abbreviated (12-hour) versus traditional (24-hour) postpartum magnesium sulfate therapy in severe pre-eclampsia. Int J Gynaecol Obstet. 2014 Sep;126(3):260-4. doi: 10.1016/j.ijgo.2014.03.024. Epub 2014 May 10.

    PMID: 24890747DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Melania M Amorim, MD; PhD

    IMIP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrical ICU obstetrical coordinator; MD , PhD

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-04

Locations

BR(1)