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

• ClinicalTrials.gov Identifier: NCT03237000
• Recruitment Status: Unknown
• First Posted: August 2, 2017
• Last Update Posted: August 2, 2017
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Maged, Cairo University

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
Preeclampsia	Drug: MgSO4	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 (Clinical Trial)
• Estimated 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.

• 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
• Estimated Study Start Date: August 1, 2017
• Estimated Primary Completion Date: December 2017
• Estimated Study Completion Date: January 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 Name: Magnisium sulfate

Outcome Measures

Primary Outcome Measures :

1. Fetal heart rate tracing [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: Ahmed Maged, MD; 01005227404; prof.ahmedmaged@gmail.com

Contact: Ahmed Ibrahim, MD; gyndoctor77@gmail.com

Locations

Egypt

Kasr Alainy medical school

Cairo, Egypt, 12151

Sponsors and Collaborators

Cairo University

Investigators

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

More Information

• Responsible Party: Ahmed Maged, Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03237000
• Other Study ID Numbers: 7
• First Posted: August 2, 2017
• Last Update Posted: August 2, 2017
• Last Verified: July 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, Cairo University:

Preeclampsia; MgSO4

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications