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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

Primary Purpose

Preeclampsia

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

MgSO4

About this trial

This is an interventional diagnostic trial for Preeclampsia

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Kasr Alainy medical school

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MgSO4

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in uterine artery resistance index

Doppler assessment of uterine artey RI

Secondary Outcome Measures

Full Information

NCT ID

NCT03891498

First Posted

March 24, 2019

Last Updated

March 25, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03891498

Brief 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

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preeclampsia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MgSO4

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MgSO4

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in uterine artery resistance index

Description

Doppler assessment of uterine artey RI

Time Frame

15 minutes after the loading dose of MgSO4

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Maged, MD

Phone

+201005227404

prof.ahmedmaged@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Elmahy, MD

Phone

01111831716

Mohamed.elmahy@kasralainy.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Maged, MD

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kasr Alainy medical school

City

Cairo

ZIP/Postal Code

12151

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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