Early Vascular Adjustments During Hypertensive Pregnancy

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    368
  • sponsor
    Maastricht University Medical Center
Updated on 1 April 2021
hypertension
labetalol
prenatal
nifedipine
antihypertensive drugs
diastolic blood pressure
antihypertensive therapy
methyldopa
gestational hypertension

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. 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.

Details
Condition Gestational Hypertension, Pre-Eclampsia, Preeclampsia, Preeclampsia, toxemia of pregnancy
Treatment methyldopa, labetalol, nifedipine
Clinical Study IdentifierNCT02531490
SponsorMaastricht University Medical Center
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients ages 18years or older
Before 37 weeks of gestational age
Diagnosed with mild to moderate gestational hypertension

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note