Clinical trial NCT03891498: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in uterine artery resistance index
timeFrame: 15 minutes after the loading dose of MgSO4
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: