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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03237000
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
5
Anticipated Duration (Months)
19.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
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.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
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

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 Names:
  • Magnisium sulfate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fetal heart rate tracing [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

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12151

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Maged, MD, kasr Alainy medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03237000
    Other Study ID Numbers:
    • 7
    First Posted:
    Aug 2, 2017
    Last Update Posted:
    Aug 2, 2017
    Last Verified:
    Jul 1, 2017
    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, Professor, Cairo University
    Preeclampsia
    MgSO4
    Additional relevant MeSH terms:
    Pre-Eclampsia

    Study Results

    No Results Posted as of Aug 2, 2017