New Magnesium Sulphate Protocol for Pre-eclampsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01846156
First received: May 1, 2013
Last updated: April 7, 2014
Last verified: April 2014

May 1, 2013
April 7, 2014
May 2013
April 2014   (final data collection date for primary outcome measure)
convulsion rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
convulsion
Same as current
Complete list of historical versions of study NCT01846156 on ClinicalTrials.gov Archive Site
ICU admission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
ICU admission
Same as current
Not Provided
Not Provided
 
New Magnesium Sulphate Protocol for Pre-eclampsia
The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial

there is a standard magnesium sulphate protocol and newer protocols for pre-eclampsia, we need to make a trial to find the best protocol

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 ≥ 160.
  • Diastolic blood pressure ≥ 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 ≥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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Pre-eclampsia
Drug: MgSO4
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
  • Experimental: Abrreviated MgSO4 protocol
    - 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.
    Intervention: Drug: MgSO4
  • Experimental: No maintenance protocol
    - 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
    Intervention: Drug: MgSO4
  • Active Comparator: standard MgSO4 protocol
    - 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: Drug: MgSO4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant females ≥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.
Female
18 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01846156
52103, 52013
Yes
Waleed El-khayat, Cairo University
Cairo University
Not Provided
Principal Investigator: Waleed El-khayat, M.D. Cairo University
Cairo University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP