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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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03891498
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: MgSO4

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

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

Outcome Measures

Primary Outcome Measures

  1. Changes in uterine artery resistance index [15 minutes after the loading dose of MgSO4]

    Doppler assessment of uterine artey RI

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kasr Alainy medical school Cairo Egypt 12151

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Ahmed Maged, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed M Maged, MD, Principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT03891498
Other Study ID Numbers:
  • 53
First Posted:
Mar 27, 2019
Last Update Posted:
Mar 27, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pre-Eclampsia

Study Results

No Results Posted as of Mar 27, 2019