PreeclampsiaMEXPRE-LatinNCT01164852
Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term
A study testing Delivery in people with Preeclampsia, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 8 sites in 6 countries.
Trial summary
How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Aug 2010to Aug 2012
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation
Who cannot join
- Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
- Persistent symptoms of preeclampsia
- Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
- Fetal death, restriction of fetal grown
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Ecuador2 sites
Hospital Terodoro Maldonado, del IESS
Gauyas
Hospital Carlos Andrade Marin
Quito
Panama2 sites
Complejo Hospitalario Caja de Seguro Social
Panama City, Provincia de Panamá
Hospital Santo Tomás
Panama City
Guatemala1 site
Hospital de Gineco-Obstetricia del seguro social
Guatemala City
Venezuela1 site
Hospital Nuestra Señora de Chiquinquira
Maracaibo, Maracaibo
About this study
Official title: Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial
How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.
Read the detailed description
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
- Conditions
- Preeclampsia
- Being tested
- Delivery
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeliveryProcedure or surgery
Also called Severe preeclampsia, expectant management of severe preeclampsia
Termination of pregnancy (delivery)after completed corticosteroids
| Study group | Role | What they receive |
|---|---|---|
| Expectant management | No intervention | Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. |
| Interventionist management | Active comparator | Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours. Receives: Procedure: Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal death
Number of perinatal in each group (interventionist or expectant management)
Measured: After begining the randomization until 4 weeks after delivery.
Secondary outcomes (1)
Perinatal complications and maternal complications
Measured: Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 264 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, MD, Principal investigator, Complejo HospitalarioJack Ludmir, MD, Study chair, Pennsylvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164852
- Sponsor's protocol ID
- ComplejoH 01
- Acronym
- MEXPRE-Latin
- Status last verified
- Aug 2012
- First submitted
- 15 Jul 2010
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01164852
- Acronym / sponsor ID
- MEXPRE-Latin / ComplejoH 01
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias MadridUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Jul 2010 (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.
How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.
Detailed description
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectant management | No intervention | –Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. |
| Interventionist management | Active comparator | Procedure: DeliveryInterventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation
Key exclusion criteria (4 listed)
- Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
- Persistent symptoms of preeclampsia
- Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
- Fetal death, restriction of fetal grown
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 |
|---|---|---|
| DeliveryAlso: Severe preeclampsia, expectant management of severe preeclampsiaTermination of pregnancy (delivery)after completed corticosteroids | Procedure or surgery | Interventionist management |
Primary outcome
Perinatal death
Time frame: After begining the randomization until 4 weeks after delivery.
Number of perinatal in each group (interventionist or expectant management)
1 secondary outcome
Perinatal complications and maternal complications
Time frame: Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.
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 14 Aug 2012.
Related trials for Preeclampsia
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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
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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.
Paulino Vigil-De Gracia, MD principal investigator
Complejo Hospitalario
Jack Ludmir, MD study chair
Pennsylvania Hospital
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery in people with Preeclampsia, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 8 sites in 6 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 1 inclusion and 4 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 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Ecuador, Panama, Guatemala, Mexico, Peru and 1 more country. 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?
Perinatal death (time frame: After begining the randomization until 4 weeks after delivery.). 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 14 Aug 2012.