NCT02307201

Brief Summary

There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,114

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
5 countries

9 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

First Submitted

Initial submission to the registry

November 24, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

November 24, 2014

Last Update Submit

January 31, 2017

Conditions

Post Partum Severe Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Eclampsia

    Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.

    24 hours postpartum

Secondary Outcomes (4)

  • Postpartum hemorrhage

    24 hours postpartum

  • Maternal respiratory distress

    24 hours postpartum

  • Grams of magnesium sulfate before delivery

    8 to 72 hours with magnesium sulfate before delivery

  • Severe hypertension postpartum

    72 hours postdelivery

Study Arms (2)

Postpartum Magnesium sulfate

EXPERIMENTAL

The patient will receive magnesium sulfate as usual for 24 hours postpartum

Drug: Magnesium Sulfate

No postpartum treatment

NO INTERVENTION

The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum

Interventions

Magnesium SulfateDRUG

The patient will receive magnesium sulfate for 24 hours postpartum

Also known as: No postpartum treatment
Postpartum Magnesium sulfate

Eligibility Criteria

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

You may qualify if:

  • Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with \> 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery
  • The study begins to terminate pregnancy

You may not qualify if:

  • HELLP syndrome
  • Eclampsia
  • Renal insufficiency
  • Diabetes mellitus
  • Disease of collagen
  • Heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hospital Materno Infantil san Lorezo de las Minas

Santo Domingo, Santo Domingo Province, Dominican Republic

Location

Hospital Universitario Maternidad Nuestra señoa de Alta Gracia

Santo Domingo, Santo Domingo Province, Dominican Republic

Location

Hospital Teodoro Maldonado De Guayaquil

Guayaquil, Ecuador

Location

Hospital Primero de Mayo

San Salvador, El Salvador

Location

Hospital Jose Domingo De Obaldia

Chiriquí, Chiriquí Province, 507, Panama

Location

Complejo Hospitalario Caja de Seguro Social

Panama City, Provincia de Panamá, 507, Panama

Location

Hospital Santo Tomás

Panama City, Provincia de Panamá, 507, Panama

Location

Hospital Regional de Cojamarca, Perú,

Cajamarca, Cajamarca Department, Peru

Location

Instituto Materno perinatal, Maternidad de Lima

Lima, Lima Province, Peru

Location

Related Publications (2)

  • 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

  • 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: 12057549RESULT

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Paulino Vigil De Gracia

    Complejo Hospitalario Dr. Arnulfo Arias Madrid

    PRINCIPAL INVESTIGATOR

  • Jack Ludmir, MD

    School of medicine, Pennsylvania Hospital. University de Pennsylvania. Philadelphia

    STUDY CHAIR

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
MEDICAL DOCTOR, GYNECOLOGY AND OBSTETRIC

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 4, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

PE(2)DO(2)EC(1)EL(1)PA(3)