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

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03237000
• Other study ID #: 7
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 31, 2017
• Last updated: July 31, 2017
• Start date: August 1, 2017
• Est. completion date: January 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: 01005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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