NCT03661775

Brief Summary

Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

October 12, 2020

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

May 14, 2018

Last Update Submit

October 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • therapeutic level

    Serum magnesium level

    4 hours after infusion magnesium sulfate

Secondary Outcomes (1)

  • Outcome of pregnancy

    24 hours after delivery

Study Arms (2)

controlled group

EXPERIMENTAL

controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour

Drug: Magnesium sulfate administration

Experimental group

EXPERIMENTAL

group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour

Drug: Magnesium sulfate administration

Interventions

controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour Experimental group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour

Experimental groupcontrolled group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy women who have MBI ≥ 31kg/m2
  • Pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more.
  • Pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more.

You may not qualify if:

  • Pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl
  • Pregnancy women who have contraindication to use magnesium sulfate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Factorial 2-by-2 open labeled randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

September 7, 2018

Study Start

September 30, 2018

Primary Completion

December 30, 2018

Study Completion

May 31, 2019

Last Updated

October 12, 2020

Record last verified: 2018-09

Locations