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Completed

NCT Number: NCT01846156

New Magnesium Sulphate Protocol for Pre-eclampsia

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

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alainy hospital

Cairo, Cairo Governorate, 12311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MgSO4

Drug

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 outcomes

  1. duration of MgSo4 treatment

    Time frame: 1 year

    treatment duration

Secondary outcomes

  1. ICU admission

    Time frame: 1 year

    ICU admission

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 3, 2013
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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