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New Magnesium Sulphate Protocol for Pre-eclampsia

Primary Purpose

Pre-eclampsia

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
MgSO4
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-eclampsia focused on measuring convulsion rate

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant females β‰₯20 weeks of gestation.
  • Pregnant females with criteria of severe pre-eclampsia.
  • Single or multi-fetal pregnancy.
  • Primigravida or Multigravida.

Exclusion Criteria:

  • Pregnant females < 20 weeks gestation.
  • Pregnant females with history of epilepsy.
  • Pregnant females with diabetes.
  • Pregnant females with chronic hypertension.
  • Pregnant females with renal disease.

Sites / Locations

  • Kasr Alainy hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Abrreviated MgSO4 protocol

No maintenance protocol

standard MgSO4 protocol

Arm Description

- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.

- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate

- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.

Outcomes

Primary Outcome Measures

duration of MgSo4 treatment
treatment duration

Secondary Outcome Measures

ICU admission
ICU admission

Full Information

First Posted
May 1, 2013
Last Updated
August 21, 2014
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01846156
Brief Title
New Magnesium Sulphate Protocol for Pre-eclampsia
Official Title
The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol
Detailed Description
The aim of our study is to assess the comparative effects of three regimens for the administration of magnesium sulfate when used for the care of women with severe pre-eclampsia. The study will include 240 pregnant women presenting to the casualty unit with criteria of severe preeclampsia in the form of one of the criteria:- Systolic blood pressure β‰₯ 160. Diastolic blood pressure β‰₯ 110. Proteinuria > +2 by dip stick. Presence of alarming symptoms (headache, visual disturbance, epigastric pain, vaginal bleeding). Fetal growth restriction (IUGR). After obtaining an informed consent the patients will be subjected to the following: Careful history taking including age, parity, gestational age. Complete physical examination and assessment of the blood pressure. Urine analysis by dipstick. All women will take initial MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes by IV drip) . Using Random Number Table, the sample size will be divided into three categories:- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period. Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period. Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate. Inclusion criteria: Pregnant females β‰₯20 weeks of gestation. Pregnant females with criteria of severe pre-eclampsia. Single or multi-fetal pregnancy. Primigravida or Multigravida. Exclusion criteria: Pregnant females < 20 weeks gestation. Pregnant females with history of epilepsy. Pregnant females with diabetes. Pregnant females with chronic hypertension. Pregnant females with renal disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-eclampsia
Keywords
convulsion rate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abrreviated MgSO4 protocol
Arm Type
Experimental
Arm Description
- Category B : 80 patients given abbreviated doses of MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip only for 12 hours) in the postpartum period.
Arm Title
No maintenance protocol
Arm Type
Experimental
Arm Description
- Category C : 80 patients who will take only loading dose of MgSO4 (6 grams of MgSO4 on 250 ml ringer solutions over 20 minutes) with no postpartum maintenance sulfate
Arm Title
standard MgSO4 protocol
Arm Type
Active Comparator
Arm Description
- Category A : 80 patients given full dose of maintenance MgSO4 (4 grams of MgSO4 on 250 ml ringer solution over 4 hours every 4 hours by IV drip for 24 hours) in the postpartum period.
Intervention Type
Drug
Intervention Name(s)
MgSO4
Intervention Description
A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
Primary Outcome Measure Information:
Title
duration of MgSo4 treatment
Description
treatment duration
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ICU admission
Description
ICU admission
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant females β‰₯20 weeks of gestation. Pregnant females with criteria of severe pre-eclampsia. Single or multi-fetal pregnancy. Primigravida or Multigravida. Exclusion Criteria: Pregnant females < 20 weeks gestation. Pregnant females with history of epilepsy. Pregnant females with diabetes. Pregnant females with chronic hypertension. Pregnant females with renal disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-khayat, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy hospital
City
Cairo
ZIP/Postal Code
12311
Country
Egypt

12. IPD Sharing Statement

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