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

Not Applicable

• Conditions: Preeclampsia
• Interventions: Drug: MgSO4

• Registration Number: NCT03891498
• Lead Sponsor: Cairo University

Brief 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

Detailed 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

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03
• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-03-25
• Last Update Submitted: 2019-03-25
• Study First Posted: 2019-03-27
• Last Update Posted: 2019-03-27
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MgSO4	MgSO4	The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose.

Primary Outcome Measures

Name	Time	Method
Changes in uterine artery resistance index	15 minutes after the loading dose of MgSO4	Doppler assessment of uterine artey RI

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt