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

Primary Purpose

Preeclampsia

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
MgSO4
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preeclampsia focused on measuring Preeclampsia, MgSO4

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MgSO4

Arm 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.

Outcomes

Primary Outcome Measures

Fetal heart rate tracing
Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted

Secondary Outcome Measures

Full Information

First Posted
July 31, 2017
Last Updated
July 31, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03237000
Brief Title
Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: Settings on a CTG machine will be standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute will be adopted. CTGs will be labelled with mother's name, hospital number. Date and time settings on machines will be labelled at commencement of tracing. Maternal heart rate will be recorded and noted on CTG. 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: Patellar reflexes should be present. Respiratory rate not < 16/min. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Preeclampsia, MgSO4

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MgSO4
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
MgSO4
Other Intervention Name(s)
Magnisium sulfate
Intervention 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.
Primary Outcome Measure Information:
Title
Fetal heart rate tracing
Description
Settings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted
Time Frame
20 minutes after MgSO4 administration

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant Women in the third trimester. Severely preeclamptic patients. Singleton Pregnancy. Patients with normal admission CTG Exclusion Criteria: Evidence of fetal anomalies on scan. Concomitant maternal morbidities as diabetes, cardiac disease. Patients contraindicated to take MgSo4 e.g.: advanced renal disease. Abnormal admission CTG. Morbid obesity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ibrahim, MD
Email
gyndoctor77@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

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

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