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Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients

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ClinicalTrials.gov Identifier: NCT03237000
Recruitment Status : Unknown
Verified July 2017 by Ahmed Maged, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Study Description
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Brief Summary:

Admission CTG for 20 minutes Settings on a CTG machine was standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. Maternal heart rate was recorded and noted on CTG. Following birth date, time and mode of delivery will be labelled on CTG.

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.

Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels


Condition or disease Intervention/treatment Phase
Preeclampsia Drug: MgSO4 Phase 4

Detailed Description:

Admission CTG:

Admission CTG will be performed for 20 minutes

I-Settings:

  1. Settings on a CTG machine will be standardised to enable a consistent approach of interpretation of traces.
  2. Paper speed of 3cm per minute will be adopted.
  3. CTGs will be labelled with mother's name, hospital number.
  4. Date and time settings on machines will be labelled at commencement of tracing.
  5. Maternal heart rate will be recorded and noted on CTG.
  6. Following birth date, time and mode of delivery will be labelled on CTG.

Magnesium Sulphate hepatahydrate administration:

Magnesium sulphate will be administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.

  • Magnesium toxicity was monitored by hourly assessment of:

    1. Patellar reflexes should be present.
    2. Respiratory rate not < 16/min.
    3. Urine output not < 100ml / hr. Another 20 minutes CTG strip will be performed 20 minutes after administration of IV loading MgSO4, 7H2O and thus ensuring that MgSO4 has reached peak serum levels

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MgSO4

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
 Drug: MgSO4

Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:

  • Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
  • Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery.
Other Name: Magnisium sulfate


Outcome Measures
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Primary Outcome Measures :
  1. Fetal heart rate tracing [ Time Frame: 20 minutes after MgSO4 administration ]
    Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant Women in the third trimester.
  2. Severely preeclamptic patients.
  3. Singleton Pregnancy.
  4. Patients with normal admission CTG

Exclusion Criteria:

  1. Evidence of fetal anomalies on scan.
  2. Concomitant maternal morbidities as diabetes, cardiac disease.
  3. Patients contraindicated to take MgSo4 e.g.: advanced renal disease.
  4. Abnormal admission CTG.
  5. Morbid obesity.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237000


Contacts
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Contact: Ahmed Maged, MD 01005227404 prof.ahmedmaged@gmail.com
Contact: Ahmed Ibrahim, MD gyndoctor77@gmail.com

Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD kasr Alainy medical school
More Information
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Responsible Party: Ahmed Maged, Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03237000     History of Changes
Other Study ID Numbers: 7
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ahmed Maged, Cairo University:
Preeclampsia
MgSO4
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
 Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents