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: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Pre-eclampsia
Drug: MgSO4
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Best Magnesium Sulphate Protocol for Severe Pre-eclampsia : A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Flushing rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Flushing


Secondary Outcome Measures:
  • ICU admission [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    ICU admission


Enrollment: 240
Study Start Date: May 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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
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
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.
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

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 ≥ 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.
  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846156

Locations
Egypt
Kasr Alainy hospital
Cairo, Egypt, 12311
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed El-khayat, M.D. Cairo University
  More Information

No publications provided

Responsible Party: Waleed El-khayat, Assistant Professor of Obstetrics & Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT01846156     History of Changes
Other Study ID Numbers: 52103, 52013
Study First Received: May 1, 2013
Last Updated: June 20, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
convulsion rate

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 28, 2014