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

NCT03891498 | Unknown DMC

• 1 other identifier: 53
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Changes in uterine artery resistance index

  Doppler assessment of uterine artey RI

  15 minutes after the loading dose of MgSO4

Study Arms (1)

MgSO4

EXPERIMENTAL

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

Drug: MgSO4

Interventions

MgSO4 DRUG

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

MgSO4

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404; prof.ahmedmaged@gmail.com

Mohamed Elmahy, MD

CONTACT

01111831716; Mohamed.elmahy@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: March 27, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

EG (1)