CClinicalTrials.gg
CompletedNCT02307201MAG-PIPUpdated Feb 1, 2017

Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia

A Phase 2/3 interventional study of Magnesium Sulfate in Post Partum Severe Preeclampsia, sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid. Completed at 9 sites in 5 countries. Open to female participants aged 14 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,114
Allocation
Randomized
Ages
14 Years to 44 Years
Sex
Female
01

Study 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 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

02

Conditions studied

  • Post Partum Severe Preeclampsia

Browse trials for

03

Who can participate

Ages eligible
14 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • HELLP syndrome
  • Eclampsia
  • Renal insufficiency
  • Diabetes mellitus
  • Disease of collagen
  • Heart disease
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,114 participants (actual)

Study arms

  • Experimental
    Postpartum Magnesium sulfate

    The patient will receive magnesium sulfate as usual for 24 hours postpartum

    Drug: Magnesium Sulfate

  • No intervention
    No postpartum treatment

    The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum

Interventions

  • DrugMagnesium Sulfate

    The patient will receive magnesium sulfate for 24 hours postpartum

    Also known as: No postpartum treatment

05

What researchers measure

Primary outcomes

  1. Eclampsia

    Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.

    Time frame: 24 hours postpartum

Secondary outcomes

  1. Postpartum hemorrhage

    Blood loss \> 500 post vaginal delivery or \> 800 cc post cesarean section, during 24 hours postpartum

    Time frame: 24 hours postpartum

  2. Maternal respiratory distress

    clinical respiratory distress,during 24 hours postpartum

    Time frame: 24 hours postpartum

  3. Grams of magnesium sulfate before delivery

    Hours and grams of magnesium sulfate before delivery

    Time frame: 8 to 72 hours with magnesium sulfate before delivery

  4. Severe hypertension postpartum

    Diastolic Blood pressure \> 110 mmHg and/or systolic blood pressure \> 160 mmHg

    Time frame: 72 hours postdelivery

06

Study locations

9 sites
  • Hospital Materno Infantil san Lorezo de las Minas
    Santo Domingo, Dominican Republic
  • Hospital Universitario Maternidad Nuestra señoa de Alta Gracia
    Santo Domingo, Dominican Republic
  • Hospital Teodoro Maldonado De Guayaquil
    Guayaquil, Ecuador
  • Hospital Primero de Mayo
    San Salvador, El Salvador
  • Hospital Jose Domingo De Obaldia
    Chiriqui, 507, Panama
  • Complejo Hospitalario Caja de Seguro Social
    Panamá, 507, Panama
  • Hospital Santo Tomás
    Panamá, 507, Panama
  • Hospital Regional de Cojamarca, Perú,
    Cajamarca, Peru
  • Instituto Materno perinatal, Maternidad de Lima
    Lima, Peru
07

References and documents

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 12540643 ↗
  • Altman 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 ↗
08

Registry details

Key details

Study ID
NCT02307201
Lead sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Responsible party
Paulino Vigil-De Gracia (MEDICAL DOCTOR, GYNECOLOGY AND OBSTETRIC, Complejo Hospitalario Dr. Arnulfo Arias Madrid) — Principal investigator
First posted
Dec 4, 2014
Start date
Dec 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 1, 2017

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion