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

Phase 4

• Conditions: Preeclampsia
• Interventions: Drug: MgSO4

• Registration Number: NCT03237000
• Lead Sponsor: Cairo University

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 Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Last Update Submitted: 2017-07-31
• Study Start: 2017-08-01
• Study First Posted: 2017-08-02
• Last Update Posted: 2017-08-02
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MgSO4	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt