Post Partum Severe PreeclampsiaPhase 2/3MAG-PIPNCT02307201
Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia
A Phase 2/3 study testing Magnesium Sulfate in people with Post Partum Severe Preeclampsia, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 9 sites in 5 countries.
Trial summary
There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have… Read more about this study
- Who is it for?
- Ages 14 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Severe Preeclampsia
- What is being tested?
- Magnesium Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,114 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 2/3
- 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 14 to 44 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with > 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery
- The study begins to terminate pregnancy
Who cannot join
- HELLP syndrome
- Eclampsia
- Renal insufficiency
- Diabetes mellitus
- Disease of collagen
- Heart disease
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Panama3 sites
Hospital Jose Domingo De Obaldia
Chiriquí, Chiriquí Province, 507
Complejo Hospitalario Caja de Seguro Social
Panama City, Provincia de Panamá, 507
Hospital Santo Tomás
Panama City, Provincia de Panamá, 507
Dominican Republic2 sites
Hospital Materno Infantil san Lorezo de las Minas
Santo Domingo, Santo Domingo Province
Hospital Universitario Maternidad Nuestra señoa de Alta Gracia
Santo Domingo, Santo Domingo Province
Peru2 sites
Hospital Regional de Cojamarca, Perú,
Cajamarca, Cajamarca Department
Instituto Materno perinatal, Maternidad de Lima
Lima, Lima Province
About this study
Official title: Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial .
There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.
Read the detailed description
The final treatment known for pre-eclampsia and eclampsia is the termination of pregnancy. However to prevent eclampsia in patients with severe pre-eclampsia has been demonstrated the effectiveness of magnesium sulfate. There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe disorder of blood pressure during pregnancy. These studies used the drug before birth and continue after birth. Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. If the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of drugs anti-eclampsia after birth. Obvious post delivery management with magnesium sulfate arises from the large number of postpartum eclampsia reported in many studies. It is unknown whether administration of magnesium sulfate for a minimum period before delivery, requires even keep the drug post partum.
In addition to magnesium sulfate postpartum, is necessary to maintain urinary catheter to monitoring the removal of magnesium sulfate; is usual to maintain the patient at all or almost all rest by monitoring sulfate and diuresis , this prevents a proper relationship mother and babe and even prevents breastfeeding during that period and is also known increased risk of secondary thromboembolism due to prolonged rest in the postpartum / caesarean section.Thus, maintain magnesium sulfate for 24 hours carries a higher cost, greater vigilance and some risks, without known real effect.
A randomized clinical study conducted by Belfort and colleagues and published in January 2003, where magnesium sulphate compared to nimodipine to prevent eclampsia in women with severe pre-eclampsia, showed interesting outcome. Such research analyzed 819 randomized patients in the nimodipine group and 831 in the magnesium sulfate group. Magnesium sulphate was better than Nimodipine in preventing eclampsia. Interestingly, the greater effectiveness of sulfate appears to prevent all eclampsia postpartum (9 vs 0) and obviously was used before the termination of pregnancy, however no difference compared with nimodipine in eclampsia before birth (12 vs 7).
There are two possible reasons for the non-appearance of postpartum eclampsia: 1- maintain postpartum magnesium sulfate, 2- dose 12-13 grams before birth disruption are sufficient to prevent eclampsia.
The MAGPIE study randomized 1335 postpartum patients (unused sulphate before delivery) using magnesium sulfate postpartum / cesarean (696 women) or placebo postpartum / cesarean (639 women), and found no significant difference in the amount of eclampsia . Thus, the use of magnesium sulfate for first time in the postpartum is not better to use a placebo. If the investigators combine the findings of eclampsia postpartum Belfort study and MAGPIE study is logical to think that the success of the Belfort study in the postpartum is not for the use of magnesium sulfate post delivery and not only due to the termination of pregnancy because there are postpartum eclampsia in the nimodipine group.
If the investigators consider unjustified use of magnesium sulfate postpartum, when maintained at least 8 hours before delivery, the investigators decided to make a non-inferiority randomized study.The investigators assume that using or not using magnesium sulfate during the postpartum prevents similar amount of postpartum eclampsia, if during pregnancy was used (impregnation and at least 8 hours before birth).
For all these reasons the investigators propose the following: A randomized trial is necessary where all those patients who received magnesium sulfate for at least 8 hours before birth (involves impregnation and maintenance 8 hours) will be randomized to two groups of study: 1- Continue magnesium sulfate for 24 hours and 2-not use magnesium sulfate or other anticonvulsant drug post delivery.
This study is planned in 12 maternity latin america
- Conditions
- Post Partum Severe Preeclampsia
- Being tested
- Magnesium Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called No postpartum treatment
The patient will receive magnesium sulfate for 24 hours postpartum
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Magnesium sulfate | Experimental | The patient will receive magnesium sulfate as usual for 24 hours postpartum Receives: Drug: Magnesium Sulfate |
| No postpartum treatment | No intervention | The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eclampsia
Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.
Measured: 24 hours postpartum
Secondary outcomes (4)
Postpartum hemorrhage
Blood loss > 500 post vaginal delivery or > 800 cc post cesarean section, during 24 hours postpartum
Measured: 24 hours postpartum
Maternal respiratory distress
clinical respiratory distress,during 24 hours postpartum
Measured: 24 hours postpartum
Grams of magnesium sulfate before delivery
Hours and grams of magnesium sulfate before delivery
Measured: 8 to 72 hours with magnesium sulfate before delivery
Severe hypertension postpartum
Diastolic Blood pressure > 110 mmHg and/or systolic blood pressure > 160 mmHg
Measured: 72 hours postdelivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Post Partum Severe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
- Investigators
- Paulino Vigil De Gracia, Principal investigator, Complejo Hospitalario Dr. Arnulfo Arias MadridJack Ludmir, MD, Study chair, School of medicine, Pennsylvania Hospital. University de Pennsylvania. Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307201
- Sponsor's protocol ID
- complejoh
- Acronym
- MAG-PIP
- Status last verified
- Jan 2017
- First submitted
- 24 Nov 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Belfort MA, Anthony J, Saade GR, Allen JC Jr; Nimodipine Study Group. A comparison of magnesium sulfate and nimodipine for the prevention of eclampsia. N Engl J Med. 2003 Jan 23;348(4):304-11. doi: 10.1056/NEJMoa021180.
PubMed 12540643Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.
PubMed 12057549
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial .
- ClinicalTrials.gov ID
- NCT02307201
- Acronym / sponsor ID
- MAG-PIP / complejoh
- Conditions
- Post Partum Severe Preeclampsia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,114 participants (actual)
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias MadridUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 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.
There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.
Detailed description
The final treatment known for pre-eclampsia and eclampsia is the termination of pregnancy. However to prevent eclampsia in patients with severe pre-eclampsia has been demonstrated the effectiveness of magnesium sulfate. There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe disorder of blood pressure during pregnancy. These studies used the drug before birth and continue after birth. Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. If the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of drugs anti-eclampsia after birth. Obvious post delivery management with magnesium sulfate arises from the large number of postpartum eclampsia reported in many studies. It is unknown whether administration of magnesium sulfate for a minimum period before delivery, requires even keep the drug post partum.
In addition to magnesium sulfate postpartum, is necessary to maintain urinary catheter to monitoring the removal of magnesium sulfate; is usual to maintain the patient at all or almost all rest by monitoring sulfate and diuresis , this prevents a proper relationship mother and babe and even prevents breastfeeding during that period and is also known increased risk of secondary thromboembolism due to prolonged rest in the postpartum / caesarean section.Thus, maintain magnesium sulfate for 24 hours carries a higher cost, greater vigilance and some risks, without known real effect.
A randomized clinical study conducted by Belfort and colleagues and published in January 2003, where magnesium sulphate compared to nimodipine to prevent eclampsia in women with severe pre-eclampsia, showed interesting outcome. Such research analyzed 819 randomized patients in the nimodipine group and 831 in the magnesium sulfate group. Magnesium sulphate was better than Nimodipine in preventing eclampsia. Interestingly, the greater effectiveness of sulfate appears to prevent all eclampsia postpartum (9 vs 0) and obviously was used before the termination of pregnancy, however no difference compared with nimodipine in eclampsia before birth (12 vs 7).
There are two possible reasons for the non-appearance of postpartum eclampsia: 1- maintain postpartum magnesium sulfate, 2- dose 12-13 grams before birth disruption are sufficient to prevent eclampsia.
The MAGPIE study randomized 1335 postpartum patients (unused sulphate before delivery) using magnesium sulfate postpartum / cesarean (696 women) or placebo postpartum / cesarean (639 women), and found no significant difference in the amount of eclampsia . Thus, the use of magnesium sulfate for first time in the postpartum is not better to use a placebo. If the investigators combine the findings of eclampsia postpartum Belfort study and MAGPIE study is logical to think that the success of the Belfort study in the postpartum is not for the use of magnesium sulfate post delivery and not only due to the termination of pregnancy because there are postpartum eclampsia in the nimodipine group.
If the investigators consider unjustified use of magnesium sulfate postpartum, when maintained at least 8 hours before delivery, the investigators decided to make a non-inferiority randomized study.The investigators assume that using or not using magnesium sulfate during the postpartum prevents similar amount of postpartum eclampsia, if during pregnancy was used (impregnation and at least 8 hours before birth).
For all these reasons the investigators propose the following: A randomized trial is necessary where all those patients who received magnesium sulfate for at least 8 hours before birth (involves impregnation and maintenance 8 hours) will be randomized to two groups of study: 1- Continue magnesium sulfate for 24 hours and 2-not use magnesium sulfate or other anticonvulsant drug post delivery.
This study is planned in 12 maternity latin america
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum Magnesium sulfate | Experimental | Drug: Magnesium SulfateThe patient will receive magnesium sulfate as usual for 24 hours postpartum |
| No postpartum treatment | No intervention | –The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum |
Who may qualify
- Ages
- 14 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with > 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery
- The study begins to terminate pregnancy
Key exclusion criteria (6 listed)
- HELLP syndrome
- Eclampsia
- Renal insufficiency
- Diabetes mellitus
- Disease of collagen
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 |
|---|---|---|
| Magnesium SulfateAlso: No postpartum treatmentThe patient will receive magnesium sulfate for 24 hours postpartum | Drug | Postpartum Magnesium sulfate |
Primary outcome
Eclampsia
Time frame: 24 hours postpartum
Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.
4 secondary outcomes
Postpartum hemorrhage
Time frame: 24 hours postpartum
Maternal respiratory distress
Time frame: 24 hours postpartum
Grams of magnesium sulfate before delivery
Time frame: 8 to 72 hours with magnesium sulfate before delivery
Severe hypertension postpartum
Time frame: 72 hours postdelivery
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 1 Feb 2017.
- Background: PubMed 12540643Belfort MA, Anthony J, Saade GR, Allen JC Jr; Nimodipine Study Group. A comparison of magnesium sulfate and nimodipine for the prevention of eclampsia. N Engl J Med. 2003 Jan 23;348(4):304-11. doi: 10.1056/NEJMoa021180.
- Results publication: PubMed 12057549Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.
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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.
Paulino Vigil De Gracia principal investigator
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Jack Ludmir, MD study chair
School of medicine, Pennsylvania Hospital. University de Pennsylvania. Philadelphia
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium Sulfate in people with Post Partum Severe Preeclampsia, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 9 sites in 5 countries.
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 6 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Panama, Dominican Republic, Peru, Ecuador, El Salvador. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Eclampsia (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 NCT02307201, 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 1 Feb 2017.