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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03237000
Enrollment
100
Registered
2017-08-02
Start date
2017-08-01
Completion date
2018-01-31
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, MgSO4

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

Interventions

DRUGMgSO4

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fetal heart rate tracing20 minutes after MgSO4 administrationSettings on a CTG machine is standardised to enable a consistent approach of interpretation of traces. Paper speed of 3cm per minute is adopted

Countries

Egypt

Contacts

Primary ContactAhmed Maged, MD
prof.ahmedmaged@gmail.com01005227404
Backup ContactAhmed Ibrahim, MD
gyndoctor77@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026