NCT02835339

Brief Summary

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Typical duration 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

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

July 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

July 7, 2016

Results QC Date

April 22, 2020

Last Update Submit

May 4, 2020

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Maternal Serum Magnesium Level at 4 Hours After Administration

    magnesium level in mg/dL

    4 hours

Secondary Outcomes (2)

  • Maternal Serum Magnesium Level at Time of Delivery

    Within 20 minutes of delivery

  • Maternal Side Effects

    4 hours

Study Arms (2)

MgSO4 4g load, 1g/hr infusion

ACTIVE COMPARATOR

Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.

Drug: Magnesium sulfate 4g loading dose, 1g/hr infusion

MgSO4 6g load, 2g/hr infusion

EXPERIMENTAL

Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.

Drug: Magnesium sulfate 6g loading dose, 2g/hr infusion

Interventions

Magnesium sulfate 4g loading dose, 1g/hr infusionDRUG
MgSO4 4g load, 1g/hr infusion
Magnesium sulfate 6g loading dose, 2g/hr infusionDRUG
MgSO4 6g load, 2g/hr infusion

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who are ages 18-45
  • weeks' pregnant
  • Prescribed magnesium sulfate for preeclampsia
  • BMI ≥35 kg/m2

You may not qualify if:

  • Pregnant women \< 32 weeks' pregnant
  • Women who are on dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science Univerity

Portland, Oregon, 97239, United States

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

  • Brookfield KF, Tuel K, Rincon M, Vinson A, Caughey AB, Carvalho B. Alternate Dosing Protocol for Magnesium Sulfate in Obese Women With Preeclampsia: A Randomized Controlled Trial. Obstet Gynecol. 2020 Dec;136(6):1190-1194. doi: 10.1097/AOG.0000000000004137.

    PMID: 33156201DERIVED

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

Results Point of Contact

Title
Kathleen Brookfield, MD, PhD, MPH
Organization
Oregon Health and Science University
brookfie@ohsu.edu
503-494-2101

Study Officials

  • Kathleen Brookfield, M.D., PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 18, 2016

Study Start

July 12, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

May 13, 2020

Results First Posted

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)