Clinical trial NCT03237000: Effect of Administering Intravenous Magnesium Sulfate on Fetal Cardiotocography and Neonatal Outcome in Preeclamptic Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preeclampsia
Keywords: Preeclampsia
MgSO4
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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

Eligibility 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.

Primary outcomes:
measure: Fetal heart rate tracing
timeFrame: 20 minutes after MgSO4 administration
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: