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

NCT03237000 | Unknown Phase 4 DMC

• 1 other identifier: 7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Preeclampsia

Keywords

Preeclampsia; MgSO4

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MgSO4

EXPERIMENTAL

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

Interventions

MgSO4 DRUG

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.

Also known as: Magnisium sulfate

MgSO4

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant Women in the third trimester.
• Severely preeclamptic patients.
• Singleton Pregnancy.
• Patients with normal admission CTG

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Maged, MD

  kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Ahmed Ibrahim, MD

CONTACT

gyndoctor77@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

EG (1)