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

Effect of Administering Intravenous Magnesium Sulfate Heptahydrate (MgSO4•7H2O) on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients in 3rd Trimester of Pregnancy

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

Study Overview

• Status: Unknown
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: MgSO4

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ahmed Ibrahim, MD; Email: gyndoctor77@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	20 minutes after MgSO4 administration

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Preeclampsia; MgSO4
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 7

Drug and device information, study documents

• 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