PreeclampsiaNCT03891498
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
A study testing MgSO4 in people with Preeclampsia, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- Oliguria or creatinine > 1.1 mg%.
- Laboratory findings characteristic of HELLP syndrome.
- Symptoms suggestive of severe preeclampsia ; severe headache, blurring of vision, epigastric pain.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Preeclampsia
- Being tested
- MgSO4
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4Drug
The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose.
| Study group | Role | What they receive |
|---|---|---|
| MgSO4 | Experimental | The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose. Receives: Drug: MgSO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in uterine artery resistance index
Doppler assessment of uterine artey RI
Measured: 15 minutes after the loading dose of MgSO4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891498
- Sponsor's protocol ID
- 53
- Status last verified
- Mar 2019
- First submitted
- 24 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03891498
- Acronym / sponsor ID
- 53
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MgSO4 | Experimental | Drug: MgSO4The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Singleton pregnancy.
- Primigravida or Multigravida.
- Pregnant females ≥ 37 weeks of gestation.
- Diagnosed as severe preeclampsia by the following criteria:
Key exclusion criteria (8 listed)
- Multifetal pregnancy.
- History of epilepsy.
- Patients with diabetes.
- Patients with renal disease.
- Fetuses with congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MgSO4The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose. | Drug | MgSO4 |
Primary outcome
Changes in uterine artery resistance index
Time frame: 15 minutes after the loading dose of MgSO4
Doppler assessment of uterine artey RI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Maged, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MgSO4 in people with Preeclampsia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (+201005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in uterine artery resistance index (time frame: 15 minutes after the loading dose of MgSO4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.