The Effect of Loading Dose of Magnesium Sulfate on Uterine, Umbilical, and Fetal Middle Cerebral Arteries Doppler, Biophysical Profile, CTG, Maternal Vital Signs in Women With Severe Preeclampsia

Preeclampsia Clinical Trial

Official title:

The Effect of Loading Dose of Magnesium Sulfate on Uterine, Umbilical, and Fetal Middle Cerebral Arteries Doppler, Biophysical Profile, CTG, Maternal Vital Signs in Women With Severe Preeclampsia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03891498
• Other study ID #: 53
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +201005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

100 women with severe preeclanpsia received Magnesium sulfate 6 grams intravenous over 20 minutes as a loading dose. Resistance index [RI], pulsatility index [PI] and systolic/diastolic [S/D] ratio of the umbilical artery, uterine aryery and fetal middle cerebral artery before and repeated 20 minutes after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes . fetal breathing movements and fetal gross movements are counted within 20 minutes, before and after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes

Description:

100 women with severe preeclanpsia received Magnesium sulfate 6 grams intravenous over 20 minutes as a loading dose. Resistance index [RI], pulsatility index [PI] and systolic/diastolic [S/D] ratio of the umbilical artery, uterine aryery and fetal middle cerebral artery before and repeated 20 minutes after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes . fetal breathing movements and fetal gross movements are counted within 20 minutes, before and after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy.

• Primigravida or Multigravida.

• Pregnant females = 37 weeks of gestation.

• Diagnosed as severe preeclampsia by the following criteria:

• Sustained systolic blood pressure of =160 mmHg or a sustained diastolic blood pressure of = 110 mmHg.

• Proteinuria measured as +1 or more by dipstick or 24 hours urine collection with proteinuria = 0.3 grams.

• Oliguria or creatinine > 1.1 mg%.

• Laboratory findings characteristic of HELLP syndrome.

• Symptoms suggestive of severe preeclampsia ; severe headache, blurring of vision, epigastric pain.

Exclusion Criteria:

• Multifetal pregnancy.

• History of epilepsy.

• Patients with diabetes.

• Patients with renal disease.

• Fetuses with congenital anomalies.

• Patients receiving anticoagulants e.g. heparin (unfractionated or low molecular weight).

• Patients with severe IUGR.

• Patients with accidental hemorrhage.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• MgSO4
The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose.

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in uterine artery resistance index	Doppler assessment of uterine artey RI	15 minutes after the loading dose of MgSO4