NCT02317146

Brief Summary

There are huge doubts as to how long to keep postpartum magnesium sulfate. Studies demonstrating the usefulness for 24, 12 or 6 hours are of little evidence and do not take into account the use of magnesium sulphate before delivery. Termination of pregnancy is the best option to prevent eclampsia and magnesium sulphate has proven effective, but do not know the minimum effective dose.The investigators believe that if the patient has received less than 8 continuous hours of magnesium sulphate before delivery, maintain magnesium sulfate for 6 hours is as effective as keeping it for 24 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

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

November 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

December 11, 2014

Last Update Submit

January 31, 2017

Conditions

Severe Pre-eclampsia With Postnatal Complication

Outcome Measures

Primary Outcomes (1)

  • Seizure (Eclampsia)

    Seizure during the first 72 hours post delivery

    72 hours postpartum

Secondary Outcomes (2)

  • Diuresis postpartum

    72 hours postpartum

  • Persistent symptomatology

    24 hours postpartum

Study Arms (2)

Six Hours Postpartum

EXPERIMENTAL

The woman received magnesium sulfate for 6 hours after delivery as prophylaxis to eclampsia.

Drug: Magnesium Sulfate

Twenty-four hours Postpartum

ACTIVE COMPARATOR

The woman received magnesium sulfate for 24 hours after delivery as prophylaxis to eclampsia.

Drug: Magnesium Sulfate

Interventions

Magnesium SulfateDRUG

Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia

Also known as: anticonvulsivant
Six Hours PostpartumTwenty-four hours Postpartum

Eligibility Criteria

Age14 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Severe hypertensive disorder receiving magnesium sulfate prophylaxis for less than 8 hours at birth.

You may not qualify if:

  • Complications such as: HELLP syndrome, renal failure, eclampsia, retinal detachment, cerebral edema, pulmonary edema, hypertensive encephalopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Jose Domingo de Obaldia

Chiriquí, Chiriquí Province, Panama

Location

Hospital Manuel Amador Guerrero

Colón, Provincia de Colón, Panama

Location

Complejo Hospitalario Caja de Seguro Social

Panama City, Provincia de Panamá, Panama

Location

Related Publications (5)

  • Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.

    PMID: 12057549BACKGROUND

  • Ascarelli MH, Johnson V, May WL, Martin RW, Martin JN Jr. Individually determined postpartum magnesium sulfate therapy with clinical parameters to safely and cost-effectively shorten treatment for pre-eclampsia. Am J Obstet Gynecol. 1998 Oct;179(4):952-6. doi: 10.1016/s0002-9378(98)70195-4.

    PMID: 9790377BACKGROUND

  • Belfort MA, Anthony J, Saade GR, Allen JC Jr; Nimodipine Study Group. A comparison of magnesium sulfate and nimodipine for the prevention of eclampsia. N Engl J Med. 2003 Jan 23;348(4):304-11. doi: 10.1056/NEJMoa021180.

    PMID: 12540643BACKGROUND

  • 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

  • Vigil-De Gracia P, Ramirez R, Duran Y, Quintero A. Magnesium sulfate for 6 vs 24 hours post delivery in patients who received magnesium sulfate for less than 8 hours before birth: a randomized clinical trial. BMC Pregnancy Childbirth. 2017 Jul 24;17(1):241. doi: 10.1186/s12884-017-1424-3.

    PMID: 28738788DERIVED

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Roberto Lewis, MD

    Caja de seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 15, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(3)