Hypertension, Pregnancy-InducedPhase 4EVANCT02531490
Early Vascular Adjustments During Hypertensive Pregnancy
A Phase 4 study testing Labetalol, Nifedipine and Methyldopa in people with Hypertension, Pregnancy-Induced and Pre-Eclampsia, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
- What is being tested?
- Labetalol, Nifedipine and Methyldopa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2015to Apr 2023
- 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
- Patients ages 18years or older
- Before 37 weeks of gestational age;
- Diagnosed with mild to moderate gestational hypertension
Who cannot join
- Women with severe hypertension: systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg.
- Women with chronic hypertension who are already on antihypertensive drugs. If no antihypertensive drugs are used yet, women with pre-existent hypertension are eligible to participate.
- Women diagnosed with preeclampsia or eclampsia in the current pregnancy.
- Women who are not able to comprehend the study outline.
- Women who have already participated in this study cannot be included a second time.
- Women who have a (relative) contra-indication for one of the possible prescribed medications (for example women who have tested positive for antinuclear antibodies, which is a contraindication for Methyldopa).
- Women who intend to terminate the pregnancy
- Women who have a fetus with a major anomaly or chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC
Maastricht
Eva Mulder, eva.mulder@mumc.nl
About this study
Official title: Personalized Hemodynamically Guided Antihypertensive Treatment in Pregnant Women With Mild to Moderate Hypertension: a Randomized Controlled Trial
Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.
- Conditions
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
- Being tested
- Labetalol, Nifedipine, Methyldopa
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Also called Trandate
NifedipineDrug
Also called Adalat
MethyldopaDrug
Also called Aldomet
| Study group | Role | What they receive |
|---|---|---|
| randomized, interventiongroup | Active comparator | Women with a hyperdynamic vasodilated profile, characterized by a mean arterial pressure (MAP)/ Heart rate (Hr) ratio ≤ 1.1 are prescribed a beta-blocker. Women with a hypodynamic vasoconstrictive profile (MAP/Hr ratio ≥ 1.4) are prescribed nifedipine. Women with normodynamic profile (MAP/Hr ratio in between 1.1 and 1.4) are prescribed Methyldopa. Receives: Drug: Labetalol; Drug: Nifedipine; Drug: Methyldopa |
| randomized, control-group | No intervention | Women who give informed consent for randomization, and are randomized to the control group will not be medicinally treated for mild to moderate gestational hypertension. |
| not-randomized, control-group | No intervention | Women who do not want to be randomized, but who give informed consent for follow-up on their data until discharge after delivery. They will receive standard care, i.e. no medication is prescribed for mild to moderate gestational hypertension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with severe gestational hypertension
Systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg, measured at every visit
Measured: from date of randomization until the date of this study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
number of patients with preeclampsia
Preeclampsia is defined as the coexistence of de novo hypertension after 20 weeks of gestation and one or more of the following new-onset conditions:
- Proteinuria (spot urine protein/creatinine ≥ 30g/mol or ≥ 300mg/day or at least 1 g/L [2+] on dipstick testing).
- Other maternal organ dysfunction:
- Renal insufficiency (creatinine levels ≥ 90μmol/L);
- Liver involvement (elevated transaminases: ASAT ≥31 U/L and/or ALAT ≥34U/L);
- Neurological complications (hyperreflexia when accompanied by clonus and/or severe headaches, persistent visual scotomata, altered mental status, eclampsia);
- Haematological complications (thrombocytopenia, platelet count below 150.000/dL, disseminated intravascular coagulation, haemolysis).
Measured: from date of randomization until the date of this study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
Secondary outcomes (15)
the pattern of change of the hemodynamic profile, measured by the ratio of mean arterial pressure and heart rate.
hemodynamic profiles will be classified as hyperdynamic, hypodynamic vasocontricted or mixed profile.
Measured: at baseline and each study visit/follow up measurement (at 1 week, 2 weeks, etc. up to 23 weeks after inclusion. The expected average is 8 weeks
hemodynamic profile by mean arterial pressure/heart rate ratio
hemodynamic profiles will be classified as hyperdynamic, hypodynamic vasocontricted or mixed profile.
Measured: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
diameter aortic outflow tract and left ventricular outflow tract measured by transthoracic echocardiography
cardiac output can be derived from these values + heart rate
Measured: from baseline, and every 4 weeks (maximum 6 times, because in max. 23 weeks end of study is reached)
left ventricular volume after diastole and systole measured by transthoracic echocardiography
ejection fraction can be derived from these values
Measured: from baseline, and every 4 weeks (maximum 6 times, because in max. 23 weeks end of study is reached)
diameter aortic outflow tract and left ventricular outflow tract measured by transthoracic echocardiography
cardiac output can be derived from these values + heart rate
Measured: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
left ventricular volume after diastole and systole measured by transthoracic echocardiography
ejection fraction can be derived from these values
Measured: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
cardiac remodeling during pregnancy: number of patients with concentric left ventricular remodeling or concentric hypertrophy.
Echocardiographic concentric left ventricular (LV) remodelling and hypertrophy. Concentric remodeling is defined as a relative wall thickness (RWT) <=0.43 with a Left Ventricular Mass index (LVMi) of <95 gram/m2. Concentric hypertrophy is defined as a RWT <0.43 with a LVMi of ≥95 gram/m2.
Measured: from baseline, and every 4 weeks (maximum 6 times, because in max. 23 weeks end of study is reached)
cardiac remodeling during pregnancy: number of patients with concentric left ventricular remodeling or concentric hypertrophy.
Echocardiographic concentric left ventricular (LV) remodelling and hypertrophy. Concentric remodeling is defined as a relative wall thickness (RWT) <=0.43 with a Left Ventricular Mass index (LVMi) of <95 gram/m2. Concentric hypertrophy is defined as a RWT <0.43 with a LVMi of ≥95 gram/m2.
Measured: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
health status of the newborn by Apgar score
scored by gynecologist or paediatrician on a scale of 1 to 10
Measured: assessed immediately after delivery
prevalence of small for gestational age infancy
birth weight and percentile combined with gestational age at delivery
Measured: assessed at delivery date
prevalence of premature neonates
gestational age at delivery
Measured: assessed at delivery date
number of a composite of adverse neonatal outcomes
Stillbirth, perinatal mortality, morbidity: chronic lung disease, neonatal sepsis, severe intra-ventricular haemorrhage (IVH) > grade II, periventricular leucomalacia > grade I, and necrotizing enterocolitis. Days on ventilation support, length of admission in neonatal intensive care, and total days in hospital until 3 months corrected age.
Measured: from delivery up neonates will be followed for the duration of the hospital stay, an expected average of 6 weeks
maternal well-being questionnaire,
Reported medication side effects, and maternal well-being by signs and symptoms during pregnancy
Measured: at baseline and each study visit/follow up measurement (at 1 week, 2 weeks, etc. up to 23 weeks after inclusion. The expected average is 8 weeks
number of assessed maternal complications
Composite of maternal complications including: mortality, stroke, eclampsia, blindness, uncontrolled hypertension, respiratory failure, birth related variables, needed level of care
Measured: from a study event participants will be followed for the duration of hospital stay, an expected average of 1 week
gestational age at the moment of progression to primary outcome.
Measured: from baseline/inclusion until a study event is reached (up to 18 weeks after inclusion), with an expected average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study start1 Jan 2015
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Spaanderman, professor, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531490
- Sponsor's protocol ID
- METC152017
- Acronym
- EVA
- Status last verified
- Mar 2021
- First submitted
- 5 Aug 2015
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Schutte JM, Schuitemaker NW, van Roosmalen J, Steegers EA; Dutch Maternal Mortality Committee. Substandard care in maternal mortality due to hypertensive disease in pregnancy in the Netherlands. BJOG. 2008 May;115(6):732-6. doi: 10.1111/j.1471-0528.2008.01702.x.
PubMed 18410657Abalos E, Duley L, Steyn DW. Antihypertensive drug therapy for mild to moderate hypertension during pregnancy. Cochrane Database Syst Rev. 2014 Feb 6;(2):CD002252. doi: 10.1002/14651858.CD002252.pub3.
PubMed 24504933Easterling TR, Benedetti TJ, Schmucker BC, Millard SP. Maternal hemodynamics in normal and preeclamptic pregnancies: a longitudinal study. Obstet Gynecol. 1990 Dec;76(6):1061-9.
PubMed 2234714Valensise H, Vasapollo B, Gagliardi G, Novelli GP. Early and late preeclampsia: two different maternal hemodynamic states in the latent phase of the disease. Hypertension. 2008 Nov;52(5):873-80. doi: 10.1161/HYPERTENSIONAHA.108.117358. Epub 2008 Sep 29.
PubMed 18824660Taler SJ, Textor SC, Augustine JE. Resistant hypertension: comparing hemodynamic management to specialist care. Hypertension. 2002 May;39(5):982-8. doi: 10.1161/01.hyp.0000016176.16042.2f.
PubMed 12019280Mulder E, Ghossein-Doha C, Appelman E, van Kuijk S, Smits L, van der Zanden R, van Drongelen J, Spaanderman M. Study protocol for the randomized controlled EVA (early vascular adjustments) trial: tailored treatment of mild hypertension in pregnancy to prevent severe hypertension and preeclampsia. BMC Pregnancy Childbirth. 2020 Dec 12;20(1):775. doi: 10.1186/s12884-020-03475-w.
PubMed 33308198
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Hemodynamically Guided Antihypertensive Treatment in Pregnant Women With Mild to Moderate Hypertension: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02531490
- Acronym / sponsor ID
- EVA / METC152017
- Conditions
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 24 Aug 2015 (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.
Paradoxical fetal and maternal results of studies have led to inconsistent use of antihypertensive drugs or no treatment at all in mild to moderate gestational hypertension in the Netherlands. However, none of the studies have taken the individual maternal circulatory state or the contemplated blood pressure response into account. Hypertension may be accompanied by high (hyperdynamic vasodilated profile), normal (normodynamic profile) of low (hypodynamic vasoconstrictive profile) cardiac output, and preeclampsia is not restricted to one circulatory profile. Therefore antihypertensive drugs should be viewed upon as correctors of the hemodynamic state rather than solely reducers of blood pressure. Without taking the maternal hemodynamic profile and condition into account, generic antihypertensive treatment can be expected to result in disappointing, inadequate and paradoxical results. The investigators hypothesize that in mild to moderate hypertension, personalized hemodynamically guided antihypertensive therapy (with target systolic and diastolic blood pressure <130/80mmHg), prevents the progression to severe hypertension and/or preeclampsia compared to no treatment, without the alleged side-effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| randomized, interventiongroup | Active comparator | Drug: Labetalol, Drug: Nifedipine, Drug: MethyldopaWomen with a hyperdynamic vasodilated profile, characterized by a mean arterial pressure (MAP)/ Heart rate (Hr) ratio ≤ 1.1 are prescribed a beta-blocker. Women with a hypodynamic vasoconstrictive profile (MAP/Hr ratio ≥ 1.4) are prescribed nifedipine. Women with normodynamic profile (MAP/Hr ratio in between 1.1 and 1.4) are prescribed Methyldopa. |
| randomized, control-group | No intervention | –Women who give informed consent for randomization, and are randomized to the control group will not be medicinally treated for mild to moderate gestational hypertension. |
| not-randomized, control-group | No intervention | –Women who do not want to be randomized, but who give informed consent for follow-up on their data until discharge after delivery. They will receive standard care, i.e. no medication is prescribed for mild to moderate gestational hypertension. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients ages 18years or older
- Before 37 weeks of gestational age;
- Diagnosed with mild to moderate gestational hypertension
Key exclusion criteria (8 listed)
- Women with severe hypertension: systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg.
- Women with chronic hypertension who are already on antihypertensive drugs. If no antihypertensive drugs are used yet, women with pre-existent hypertension are eligible to participate.
- Women diagnosed with preeclampsia or eclampsia in the current pregnancy.
- Women who are not able to comprehend the study outline.
- Women who have already participated in this study cannot be included a second time.
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 |
|---|---|---|
| LabetalolAlso: Trandate | Drug | randomized, interventiongroup |
| NifedipineAlso: Adalat | Drug | randomized, interventiongroup |
| MethyldopaAlso: Aldomet | Drug | randomized, interventiongroup |
Primary outcome
number of patients with severe gestational hypertension
Time frame: from date of randomization until the date of this study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
Systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 110mmHg, measured at every visit
number of patients with preeclampsia
Time frame: from date of randomization until the date of this study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
Preeclampsia is defined as the coexistence of de novo hypertension after 20 weeks of gestation and one or more of the following new-onset conditions: 1. Proteinuria (spot urine protein/creatinine ≥ 30g/mol or ≥ 300mg/day or at least 1 g/L [2+] on dipstick testing). 2. Other maternal organ dysfunction: * Renal insufficiency (creatinine levels ≥ 90μmol/L); * Liver involvement (elevated transaminases: ASAT ≥31 U/L and/or ALAT ≥34U/L); * Neurological complications (hyperreflexia when accompanied by clonus and/or severe headaches, persistent visual scotomata, altered mental status, eclampsia); * Haematological complications (thrombocytopenia, platelet count below 150.000/dL, disseminated intravascular coagulation, haemolysis).
15 secondary outcomes
the pattern of change of the hemodynamic profile, measured by the ratio of mean arterial pressure and heart rate.
Time frame: at baseline and each study visit/follow up measurement (at 1 week, 2 weeks, etc. up to 23 weeks after inclusion. The expected average is 8 weeks
hemodynamic profile by mean arterial pressure/heart rate ratio
Time frame: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
diameter aortic outflow tract and left ventricular outflow tract measured by transthoracic echocardiography
Time frame: from baseline, and every 4 weeks (maximum 6 times, because in max. 23 weeks end of study is reached)
left ventricular volume after diastole and systole measured by transthoracic echocardiography
Time frame: from baseline, and every 4 weeks (maximum 6 times, because in max. 23 weeks end of study is reached)
diameter aortic outflow tract and left ventricular outflow tract measured by transthoracic echocardiography
Time frame: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
left ventricular volume after diastole and systole measured by transthoracic echocardiography
Time frame: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
cardiac remodeling during pregnancy: number of patients with concentric left ventricular remodeling or concentric hypertrophy.
Time frame: from baseline, and every 4 weeks (maximum 6 times, because in max. 23 weeks end of study is reached)
cardiac remodeling during pregnancy: number of patients with concentric left ventricular remodeling or concentric hypertrophy.
Time frame: from date of randomization until the date of study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)
health status of the newborn by Apgar score
Time frame: assessed immediately after delivery
prevalence of small for gestational age infancy
Time frame: assessed at delivery date
prevalence of premature neonates
Time frame: assessed at delivery date
number of a composite of adverse neonatal outcomes
Time frame: from delivery up neonates will be followed for the duration of the hospital stay, an expected average of 6 weeks
maternal well-being questionnaire,
Time frame: at baseline and each study visit/follow up measurement (at 1 week, 2 weeks, etc. up to 23 weeks after inclusion. The expected average is 8 weeks
number of assessed maternal complications
Time frame: from a study event participants will be followed for the duration of hospital stay, an expected average of 1 week
gestational age at the moment of progression to primary outcome.
Time frame: from baseline/inclusion until a study event is reached (up to 18 weeks after inclusion), with an expected average of 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 18410657Schutte JM, Schuitemaker NW, van Roosmalen J, Steegers EA; Dutch Maternal Mortality Committee. Substandard care in maternal mortality due to hypertensive disease in pregnancy in the Netherlands. BJOG. 2008 May;115(6):732-6. doi: 10.1111/j.1471-0528.2008.01702.x.
- Background: PubMed 24504933Abalos E, Duley L, Steyn DW. Antihypertensive drug therapy for mild to moderate hypertension during pregnancy. Cochrane Database Syst Rev. 2014 Feb 6;(2):CD002252. doi: 10.1002/14651858.CD002252.pub3.
- Background: PubMed 2234714Easterling TR, Benedetti TJ, Schmucker BC, Millard SP. Maternal hemodynamics in normal and preeclamptic pregnancies: a longitudinal study. Obstet Gynecol. 1990 Dec;76(6):1061-9.
- Background: PubMed 18824660Valensise H, Vasapollo B, Gagliardi G, Novelli GP. Early and late preeclampsia: two different maternal hemodynamic states in the latent phase of the disease. Hypertension. 2008 Nov;52(5):873-80. doi: 10.1161/HYPERTENSIONAHA.108.117358. Epub 2008 Sep 29.
- Background: PubMed 12019280Taler SJ, Textor SC, Augustine JE. Resistant hypertension: comparing hemodynamic management to specialist care. Hypertension. 2002 May;39(5):982-8. doi: 10.1161/01.hyp.0000016176.16042.2f.
- Derived from this study: PubMed 33308198Mulder E, Ghossein-Doha C, Appelman E, van Kuijk S, Smits L, van der Zanden R, van Drongelen J, Spaanderman M. Study protocol for the randomized controlled EVA (early vascular adjustments) trial: tailored treatment of mild hypertension in pregnancy to prevent severe hypertension and preeclampsia. BMC Pregnancy Childbirth. 2020 Dec 12;20(1):775. doi: 10.1186/s12884-020-03475-w.
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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.
Marc Spaanderman, professor principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Labetalol, Nifedipine and Methyldopa in people with Hypertension, Pregnancy-Induced and Pre-Eclampsia, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Mulder, MD (0031650504243, eva.mulder@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with severe gestational hypertension (time frame: from date of randomization until the date of this study event, assessed up to 1 week post partum (maximum 23weeks after inclusion)). The study lists 2 primary outcomes in all. 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 NCT02531490, which also lists 6 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 24 Mar 2021.