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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

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date August 2, 2017
Estimated Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients
Official Title  ICMJE Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy
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

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Preeclampsia
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: MgSO4
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237000
Other Study ID Numbers  ICMJE 7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Maged, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Maged, MD kasr Alainy medical school
PRS Account Cairo University
Verification Date July 2017

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