Severe Pre-EclampsiaNCT05283473
Serum Magnesium Concentration in Magnesium Sulfate Therapy for Severe Preeclampsia
An observational study of Severe Pre-Eclampsia, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
Pregnant women diagnosed with pre-eclampsia with severe features will be treated with magnesium sulfate to prevent seizures. Magnesium sulfate will be administered according to My Duc Hospital's protocol for treatment of pre-eclampsia (a loading dose of 4.5g given intravenously in 20 min, followed by a maintenance… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Pre-Eclampsia
- How many people
- 64 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Mar 2022to 30 Mar 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women aged minimum 18 who are admitted to My Duc Hospital with severe pre-eclampsia, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria, and indicated for therapy with magnesium sulfate will be included.
Who may be able to join
- Pregnant women
- Aged ≥ 18
- Diagnosed with pre-eclampsia with severe features, with or without chronic hypertension, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria.
- Provision of written informed consent to participate as shown by a signature on the patient consent form.
Who cannot join
- Impaired renal function (eGFR < 60 mL/min/ 1,73 m2 or oliguria )
- Occurrence of eclampsia before magnesium sulfate administration
- Known hypersensitivity to the drug,
- Severe myasthenia, atrioventricular block
- A diminished level of consciousness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Concentration of Magnesium Attained in Magnesium Sulfate Therapy in Pregnant Women With Severe Preeclampsia
Pregnant women diagnosed with pre-eclampsia with severe features will be treated with magnesium sulfate to prevent seizures. Magnesium sulfate will be administered according to My Duc Hospital's protocol for treatment of pre-eclampsia (a loading dose of 4.5g given intravenously in 20 min, followed by a maintenance dose at an infusion rate of 1.5g/h). Serum magnesium concentrations will be measured before the loading dose and 0.5h, 1h, 2h, and every 6 hours thereafter.
Read the detailed description
This observational, longitudinal, prospective case-series aims to assess serum magnesium concentrations at specific times in pregnant women treated with magnesium sulfate for pre-eclampsia with severe features.
Pregnant women aged minimum 18 who are admitted to My Duc Hospital with severe pre-eclampsia, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria, will be indicated for therapy with magnesium sulfate. Only those who give written informed consent will be included in the study. According to the ACOG criteria, pre-eclampsia is considered severe if present with any of the following features : systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg, thrombocytopenia (<100,000/mm3) abnormal liver function (increase in transaminases to twice the normal value or pain in the upper right quadrant/epigastrium that is unresponsive to medication), abnormal renal function (creatinine >1.1 mg/dl or twice normal values), acute pulmonary edema and/or new cerebral and/or visual symptoms.
Exclusion criteria includes impaired renal function (eGFR < 60 mL/min/ 1,73 m2 or oliguria ), known hypersensitivity to the drug, severe myasthenia, atrioventricular block or a diminished level of consciousness.
All patients will be given the standard loading dose of 4.5 grams of magnesium sulfate administered over 20 minutes, followed by a maintenance dose of magnesium sulfate at an infusion rate of 1.5g/h, in compliance with My Duc Hospital's guidelines. Maternal blood samples will be obtained for serum magnesium and creatinine concentrations at baseline prior to magnesium sulfate administration; at 30 min, 1 hour, 2 hours, 4 hours and every 6 hours until discontinuation of magnesium sulfate therapy. Antihypertensive medications can be given according to My Duc Hospital's guidelines.
Patients can choose to withdraw from the study at any point without affect on the course of treatment. Investigators can also offer patients to opt out of the study for medical emergencies.
Magnesium sulfate therapy will be discontinued if there is any sign of magnesium toxicity, or the patient has been stable for 24 hours of treatment without any severe hypertensive episode or convulsion.
All patients will be followed up until delivery and both mother and neonate are discharged to record obstetric and neonatal outcomes.
- Conditions
- Severe Pre-Eclampsia
- Keywords
- Pre-eclampsia, Magnesium sulfate, Eclampsia, magnesium concentration
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum magnesium concentrations before and during magnesium sulfate infusion
Serum magnesium concentrations are measured immediately before the loading dose of magnesium sulfate and at 30 min, 1 hr, 2 hr, 4 hr, 6 hr and then every 6 hours during magnesium sulfate infusion.
Measured: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Secondary outcomes (24)
Adverse drug reaction
Rates of adverse drug reactions to administration of magnesium sulfate
Measured: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Magnesium toxicity
Rates of patients having signs of magnesium toxicity
Measured: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Mode of delivery
Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)
Measured: At birth
Gestational age at delivery
Gestational age at delivery
Measured: At birth
Rate of preterm birth before 28 weeks of gestation
Birth before 28 weeks
Measured: From date of enrollment until 27 6/7 weeks
Rate of preterm birth before 34 weeks of gestation
Birth before 34 weeks
Measured: From date of enrollment until 33 6/7 weeks
Rate of all live births at any gestational age
The birth of at least one newborn, regardless of gestational age, that exhibits any sign of life such as respiration, heartbeat, umbilical pulsation or movement of voluntary muscles
Measured: At birth
Rate of maternal mortality
Death of the mother
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of eclampsia
Onset of seizures (convulsions) in a patient with pre-eclampsia
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of HELLP syndrome
The clinical presentation of hemolysis, elevated liver enzymes, and low platelet count in a patient with pre-eclampsia
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of placental abruption
Separation of placenta from the inner wall of the uterus before birth
Measured: From date of enrollment until date of delivery, up to 12 weeks
Rate of postpartum hemorrhage
A cumulative blood loss of greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process
Measured: Within 24 hours after delivery
Rate of stroke
Occurrence of stroke in a patient with pre-eclampsia
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of acute kidney injury
A sudden episode of kidney failure or kidney damage that happens within a few hours or a few days in a patient with pre-eclampsia
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of liver capsule hematoma or rupture
Occurrence of hepatic rupture or hematoma in a patient with pre-eclampsia
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of pulmonary edema
Accumulation of excess fluid in the lungs of a patient with pre-eclampsia
Measured: From date of enrollment until date of discharge, up to 12 weeks
Rate of stillbirth
Infant born with no sign of life at or after 20 weeks' gestation
Measured: After 20 weeks of gestation until the date of delivery
Birthweight
Weight of infant born
Measured: At birth
Rate of small-for-gestational-age
Babies born with birthweights below the 10th percentile for babies of the same gestational age.
Measured: At birth
5-minute Apgar score
Apgar score at 5 minute after birth. 5-minute Apgar score of 7-10 as reassuring, a score of 4-5 as moderately abnormal, and a score of 0-3 as low in the term infant and late-preterm infant.
Measured: At birth
Rate of admission to the neonatal intensive care unit (NICU)
Admission of infant to the neonatal intensive care unit
Measured: Up to 28 days of life after the due date
Rate of death before discharge
Death of newborn before discharge from nursery
Measured: Up to 28 days of life after the due date
Rate of respiratory distress syndrome
Presence of tachypnoea, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram
Measured: Up to 28 days of life after the due date
Rate of proven sepsis
The combination of clinical signs and positive blood cultures
Measured: Up to 28 days of life after the due date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 Mar 2022
- Primary completion21 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pre-EclampsiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283473
- Sponsor's protocol ID
- 01/22/DD-BVMD
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentration of Magnesium Attained in Magnesium Sulfate Therapy in Pregnant Women With Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT05283473
- Acronym / sponsor ID
- 01/22/DD-BVMD
- Conditions
- Severe Pre-Eclampsia
- Keywords
- Pre-eclampsia, Magnesium sulfate, Eclampsia, magnesium concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Mar 2022 (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.
Pregnant women diagnosed with pre-eclampsia with severe features will be treated with magnesium sulfate to prevent seizures. Magnesium sulfate will be administered according to My Duc Hospital's protocol for treatment of pre-eclampsia (a loading dose of 4.5g given intravenously in 20 min, followed by a maintenance dose at an infusion rate of 1.5g/h). Serum magnesium concentrations will be measured before the loading dose and 0.5h, 1h, 2h, and every 6 hours thereafter.
Detailed description
This observational, longitudinal, prospective case-series aims to assess serum magnesium concentrations at specific times in pregnant women treated with magnesium sulfate for pre-eclampsia with severe features.
Pregnant women aged minimum 18 who are admitted to My Duc Hospital with severe pre-eclampsia, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria, will be indicated for therapy with magnesium sulfate. Only those who give written informed consent will be included in the study. According to the ACOG criteria, pre-eclampsia is considered severe if present with any of the following features : systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg, thrombocytopenia (<100,000/mm3) abnormal liver function (increase in transaminases to twice the normal value or pain in the upper right quadrant/epigastrium that is unresponsive to medication), abnormal renal function (creatinine >1.1 mg/dl or twice normal values), acute pulmonary edema and/or new cerebral and/or visual symptoms.
Exclusion criteria includes impaired renal function (eGFR < 60 mL/min/ 1,73 m2 or oliguria ), known hypersensitivity to the drug, severe myasthenia, atrioventricular block or a diminished level of consciousness.
All patients will be given the standard loading dose of 4.5 grams of magnesium sulfate administered over 20 minutes, followed by a maintenance dose of magnesium sulfate at an infusion rate of 1.5g/h, in compliance with My Duc Hospital's guidelines. Maternal blood samples will be obtained for serum magnesium and creatinine concentrations at baseline prior to magnesium sulfate administration; at 30 min, 1 hour, 2 hours, 4 hours and every 6 hours until discontinuation of magnesium sulfate therapy. Antihypertensive medications can be given according to My Duc Hospital's guidelines.
Patients can choose to withdraw from the study at any point without affect on the course of treatment. Investigators can also offer patients to opt out of the study for medical emergencies.
Magnesium sulfate therapy will be discontinued if there is any sign of magnesium toxicity, or the patient has been stable for 24 hours of treatment without any severe hypertensive episode or convulsion.
All patients will be followed up until delivery and both mother and neonate are discharged to record obstetric and neonatal outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women aged minimum 18 who are admitted to My Duc Hospital with severe pre-eclampsia, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria, and indicated for therapy with magnesium sulfate will be included.
Key inclusion criteria (4 listed)
- Pregnant women
- Aged ≥ 18
- Diagnosed with pre-eclampsia with severe features, with or without chronic hypertension, as defined by the American College of Obstetricians and Gynecologists (ACOG) diagnosis criteria.
- Provision of written informed consent to participate as shown by a signature on the patient consent form.
Key exclusion criteria (5 listed)
- Impaired renal function (eGFR < 60 mL/min/ 1,73 m2 or oliguria )
- Occurrence of eclampsia before magnesium sulfate administration
- Known hypersensitivity to the drug,
- Severe myasthenia, atrioventricular block
- A diminished level of consciousness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum magnesium concentrations before and during magnesium sulfate infusion
Time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Serum magnesium concentrations are measured immediately before the loading dose of magnesium sulfate and at 30 min, 1 hr, 2 hr, 4 hr, 6 hr and then every 6 hours during magnesium sulfate infusion.
24 secondary outcomes
Adverse drug reaction
Time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Magnesium toxicity
Time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.
Mode of delivery
Time frame: At birth
Gestational age at delivery
Time frame: At birth
Rate of preterm birth before 28 weeks of gestation
Time frame: From date of enrollment until 27 6/7 weeks
Rate of preterm birth before 34 weeks of gestation
Time frame: From date of enrollment until 33 6/7 weeks
Rate of all live births at any gestational age
Time frame: At birth
Rate of maternal mortality
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of eclampsia
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of HELLP syndrome
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of placental abruption
Time frame: From date of enrollment until date of delivery, up to 12 weeks
Rate of postpartum hemorrhage
Time frame: Within 24 hours after delivery
Rate of stroke
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of acute kidney injury
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of liver capsule hematoma or rupture
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of pulmonary edema
Time frame: From date of enrollment until date of discharge, up to 12 weeks
Rate of stillbirth
Time frame: After 20 weeks of gestation until the date of delivery
Birthweight
Time frame: At birth
Rate of small-for-gestational-age
Time frame: At birth
5-minute Apgar score
Time frame: At birth
Rate of admission to the neonatal intensive care unit (NICU)
Time frame: Up to 28 days of life after the due date
Rate of death before discharge
Time frame: Up to 28 days of life after the due date
Rate of respiratory distress syndrome
Time frame: Up to 28 days of life after the due date
Rate of proven sepsis
Time frame: Up to 28 days of life after the due date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
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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.
Lan N Vuong, MD, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Pre-Eclampsia, run by Mỹ Đức Hospital at 1 site in Vietnam.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum magnesium concentrations before and during magnesium sulfate infusion (time frame: From administration of loading dose until termination of magnesium sulfate treatment or occurrence of magnesium toxicity, whichever comes first, approximately up to 36 hours.). 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 7 Jan 2025.