PreeclampsiaNCT00666133
Treatment Approaches for Preeclampsia in Low-Resource Settings
A study testing SpringFusor Pump in people with Preeclampsia, run by Gynuity Health Projects at 2 sites in India.
Trial summary
Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- SpringFusor Pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 2 sitesIndia
- Study dates
- Apr 2008to Oct 2009
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exhibit systolic blood pressure > 140mm Hg OR a diastolic pressure > 100 mm Hg;
- Exhibit proteinuria > 1+;
- Have not given birth, or be 24h or less postpartum;
- Exhibit urine output >100 ml or more during the previous 4h or greater than 25 mL/h;
- 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
Trial locations and contacts
2 sites in 1 country.
India2 sites
Government Medical College
Nagpur, Maharashtra, 440015
Christian Medical College
Vellore, Tamil Nadu, 632004
About this study
Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia.
Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.
The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.
- Conditions
- Preeclampsia
- Being tested
- SpringFusor Pump
- Keywords
- Preeclampsia, Eclampsia, Magnesium Sulfate
- Medical subject headings
- Pre-Eclampsia, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpringFusor PumpDevice
Women in Group I (Springfusor® arm) will receive loading and maintenance doses of magnesium sulfate administered via an IV infusion administered with the Springfusor pump, a simple, inexpensive flow-controlled pump system.
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | Women in Group II (standard of care) will receive an 8 mL loading dose containing 4g magnesium sulfate administered manually per standard hospital protocol. The solution will be diluted with normal saline according to standard hospital practice, and given IV over 20 minutes. For women in Group II, the IV loading dose will be followed immediately with 20 mL treatment by IM injection, given as 10 mL (5 g magnesium sulfate) into each buttock. This dose will be followed by 10 mL treatments (5g magnesium sulfate) every four hours, injected into alternate buttock. Treatment will be discontinued when clinically indicated. |
| 1 | Experimental | Women in Group I (Springfusor® arm) will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4will be administered using the Springfusor® pump. For women in Group I, the administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. The pump will be started immediately after the initial bolus and the 4g dose repeated (and syringe replaced) every four hours for upto 24 hours postpartum. Receives: Device: SpringFusor Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
completed course of treatment
Measured: 24 hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Chhatrapati Shahuji Maharaj Medical University, Government Medical College, Nagpur, MacArthur Foundation
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projeccts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666133
- Sponsor's protocol ID
- 4.2.1
- Status last verified
- Dec 2009
- First submitted
- 22 Apr 2008
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Salinger DH, Mundle S, Regi A, Bracken H, Winikoff B, Vicini P, Easterling T. Magnesium sulphate for prevention of eclampsia: are intramuscular and intravenous regimens equivalent? A population pharmacokinetic study. BJOG. 2013 Jun;120(7):894-900. doi: 10.1111/1471-0528.12222. Epub 2013 Mar 26.
PubMed 23530757
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Approaches for Preeclampsia in Low-Resource Settings
- ClinicalTrials.gov ID
- NCT00666133
- Acronym / sponsor ID
- 4.2.1
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Eclampsia, Magnesium Sulfate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India, Chhatrapati Shahuji Maharaj Medical University, Government Medical College, Nagpur, MacArthur Foundation
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Apr 2008 (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.
Preeclampsia is a condition unique to pregnancy characterized by the new onset of hypertension and proteinuria. Eclampsia, characterized by maternal seizures, is a serious complication increasing the risk of maternal and infant mortality and morbidity. Magnesium sulfate is the drug of choice for prevention and treating convulsions in severe preeclampsia and eclampsia.
Magnesium sulfate is administered parenterally by intramuscular (IM) or intravenous routes (IV). In general a loading dose of 4 to 5 grams of magnesium sulfate is administered intravenously followed by an IM injection every 4 hours or by a continuous IV infusion. The IV regimen achieves more stable serum levels of magnesium but requires the use of an infusion pump for safe delivery and has a greater potential for inadvertent overdose. Although magnesium sulfate has been demonstrated as a safe and effective drug for the treatment and prevention of severe preeclampsia and eclampsia, concerns about the safety of the drug remain. The IM dosing regimen, while potentially safer, requires repeated painful IM injections. These limitations in administration hinder the widespread use of magnesium sulfate despite its demonstrated benefits.
The goal of this research is to develop a system of care that avoids overdose and facilitates the use of magnesium sulfate for the treatment of preeclampsia. To this end, a primary objective of this research is to demonstrate the safety of a simple, inexpensive flow controlled pump system (Springfusor®). This randomized study will compare the administration of magnesium sulfate by the Springfusor® controlled pump with an IM regimen, the standard of care in most hospitals in India. The study will document the efficacy and acceptability of each treatment for patients and staff and compare the cost and time elements involved in providing each method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –Women in Group II (standard of care) will receive an 8 mL loading dose containing 4g magnesium sulfate administered manually per standard hospital protocol. The solution will be diluted with normal saline according to standard hospital practice, and given IV over 20 minutes. For women in Group II, the IV loading dose will be followed immediately with 20 mL treatment by IM injection, given as 10 mL (5 g magnesium sulfate) into each buttock. This dose will be followed by 10 mL treatments (5g magnesium sulfate) every four hours, injected into alternate buttock. Treatment will be discontinued when clinically indicated. |
| 1 | Experimental | Device: SpringFusor PumpWomen in Group I (Springfusor® arm) will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4will be administered using the Springfusor® pump. For women in Group I, the administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. The pump will be started immediately after the initial bolus and the 4g dose repeated (and syringe replaced) every four hours for upto 24 hours postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Exhibit systolic blood pressure > 140mm Hg OR a diastolic pressure > 100 mm Hg;
- Exhibit proteinuria > 1+;
- Have not given birth, or be 24h or less postpartum;
- Exhibit urine output >100 ml or more during the previous 4h or greater than 25 mL/h;
- Agree to comply with study procedures;
Key exclusion criteria (2 listed)
- Eclamptic or seizing at the time of enrollment
- Received magnesium sulfate therapy 24h prior to study enrollment
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 PumpWomen in Group I (Springfusor® arm) will receive loading and maintenance doses of magnesium sulfate administered via an IV infusion administered with the Springfusor pump, a simple, inexpensive flow-controlled pump system. | Device | 1 |
Primary outcome
completed course of treatment
Time frame: 24 hours postpartum
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 9 Dec 2009.
- Derived from this study: PubMed 23530757Salinger DH, Mundle S, Regi A, Bracken H, Winikoff B, Vicini P, Easterling T. Magnesium sulphate for prevention of eclampsia: are intramuscular and intravenous regimens equivalent? A population pharmacokinetic study. BJOG. 2013 Jun;120(7):894-900. doi: 10.1111/1471-0528.12222. Epub 2013 Mar 26.
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projeccts
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpringFusor Pump in people with Preeclampsia, run by Gynuity Health Projects at 2 sites in India.
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 7 inclusion and 2 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 9 Dec 2009. 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 India. 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?
completed course of treatment (time frame: 24 hours postpartum). 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 NCT00666133, which also lists 1 linked publication.
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 9 Dec 2009.