PreeclampsiaPhase 4NCT02091401
A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
A Phase 4 study testing Springfusor infusion pump, IV administration and Magnesium Sulfate in people with Preeclampsia, run by Gynuity Health Projects at 2 sites in Egypt.
Trial summary
The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Springfusor infusion pump, IV administration and Magnesium Sulfate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2015to Feb 2016
- Phase
- Phase 4
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Exhibit systolic blood pressure > 160mm Hg OR a diastolic pressure > 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes).
- Exhibit proteinuria > 1+; Have not given birth, or be <24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be > 18 years of age Give informed consent for study participation
Who cannot join
- Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine >1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if >1.2 mg/dL in order to have a proper dose adjustment.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Shatby Maternity Hospital
Alexandria
El Galaa Teaching Hospital
Cairo, 11511
About this study
Official title: A Randomized Open-label Study to Compare the Clinical Outcomes and Magnesium Serum Concentrations Obtained in the Treatment of Severe Preeclampsia With a Repeat Bolus Intravenous Magnesium Sulfate Regimen Administered With the Springfusor Infusion Pump to a Continuous Intravenous Magnesium Sulfate Regimen
The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.
- Conditions
- Preeclampsia
- Being tested
- Springfusor infusion pump, IV administration, Magnesium Sulfate
- Keywords
- magnesium sulfate
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Springfusor infusion pumpDevice
IV administrationOther
Magnesium SulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| IV | Active comparator | Women randomized into this treatment group will receive magnesium sulfate via an IV loading dose administered manually by study staff and an IV maintenance regimen. Receives: Other: IV administration; Drug: Magnesium Sulfate |
| Springfusor | Experimental | Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump). Receives: Device: Springfusor infusion pump; Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnesium concentration
Blood draw times will be structured so as to perform a robust population PK analysis. Time zero is the end of the bolus administration. In the Springfusor arm, samples will be collected at the following times: 00:00, 00:20; 00:40; 1:20; 2:00; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00. In the IV arm, samples will be collected at the following times: 0:00; 00:20; 00:40;1:00; 1:20; 1:40; 2:20; 3:00; 3:40; 4:20; 5:20; 6:40; 8:00; 9:20; 10:40 and 12:00.
Measured: 00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hillary Bracken, PhD, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091401
- Sponsor's protocol ID
- 4002
- Status last verified
- Oct 2016
- First submitted
- 17 Mar 2014
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
PubMed 37815037Easterling T, Hebert M, Bracken H, Darwish E, Ramadan MC, Shaarawy S, Charles D, Abdel-Aziz T, Nasr AS, Safwal SM, Winikoff B. A randomized trial comparing the pharmacology of magnesium sulfate when used to treat severe preeclampsia with serial intravenous boluses versus a continuous intravenous infusion. BMC Pregnancy Childbirth. 2018 Jul 6;18(1):290. doi: 10.1186/s12884-018-1919-6.
PubMed 29976161
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Study to Compare the Clinical Outcomes and Magnesium Serum Concentrations Obtained in the Treatment of Severe Preeclampsia With a Repeat Bolus Intravenous Magnesium Sulfate Regimen Administered With the Springfusor Infusion Pump to a Continuous Intravenous Magnesium Sulfate Regimen
- ClinicalTrials.gov ID
- NCT02091401
- Acronym / sponsor ID
- 4002
- Conditions
- Preeclampsia
- Keywords
- magnesium sulfate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Mar 2014 (estimated)
- 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.
The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV | Active comparator | Other: IV administration, Drug: Magnesium SulfateWomen randomized into this treatment group will receive magnesium sulfate via an IV loading dose administered manually by study staff and an IV maintenance regimen. |
| Springfusor | Experimental | Device: Springfusor infusion pump, Drug: Magnesium SulfateWomen randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Exhibit systolic blood pressure > 160mm Hg OR a diastolic pressure > 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes).
- Exhibit proteinuria > 1+; Have not given birth, or be <24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be > 18 years of age Give informed consent for study participation
Key exclusion criteria (1 listed)
- Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine >1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if >1.2 mg/dL in order to have a proper dose adjustment.
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 |
|---|---|---|
| Springfusor infusion pump | Device | Springfusor |
| IV administration | Other | IV |
| Magnesium Sulfate | Drug | IV, Springfusor |
Primary outcome
Magnesium concentration
Time frame: 00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00
Blood draw times will be structured so as to perform a robust population PK analysis. Time zero is the end of the bolus administration. In the Springfusor arm, samples will be collected at the following times: 00:00, 00:20; 00:40; 1:20; 2:00; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00. In the IV arm, samples will be collected at the following times: 0:00; 00:20; 00:40;1:00; 1:20; 1:40; 2:20; 3:00; 3:40; 4:20; 5:20; 6:40; 8:00; 9:20; 10:40 and 12:00.
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 4 Oct 2016.
- Derived from this study: PubMed 37815037Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
- Derived from this study: PubMed 29976161Easterling T, Hebert M, Bracken H, Darwish E, Ramadan MC, Shaarawy S, Charles D, Abdel-Aziz T, Nasr AS, Safwal SM, Winikoff B. A randomized trial comparing the pharmacology of magnesium sulfate when used to treat severe preeclampsia with serial intravenous boluses versus a continuous intravenous infusion. BMC Pregnancy Childbirth. 2018 Jul 6;18(1):290. doi: 10.1186/s12884-018-1919-6.
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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.
Hillary Bracken, PhD study director
Gynuity Health Projects
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Springfusor infusion pump, IV administration and Magnesium Sulfate in people with Preeclampsia, run by Gynuity Health Projects at 2 sites 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 2 inclusion and 1 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 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Magnesium concentration (time frame: 00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091401, which also lists 2 linked publications.
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 4 Oct 2016.