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Early Vascular Adjustments During Hypertensive Pregnancy

Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pregnancy-Induced; Pre-Eclampsia

Intervention: Labetalol (Drug); Nifedipine (Drug); Methyldopa (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Maastricht University Medical Center

Official(s) and/or principal investigator(s):
Marc Spaanderman, professor, Principal Investigator, Affiliation: Maastricht University Medical Centre

Overall contact:
Eva Mulder, MD, Phone: 0031650504243, Email: eva.mulder@mumc.nl

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.

Clinical Details

Official title: Personalized Hemodynamically Guided Antihypertensive Treatment in Pregnant Women With Mild to Moderate Hypertension: a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

number of patients with severe gestational hypertension

number of patients with preeclampsia

Secondary outcome:

the pattern of change of the hemodynamic profile, measured by the ratio of mean arterial pressure and heart rate.

hemodynamic profile by mean arterial pressure/heart rate ratio

cardiac function measured by transthoracic echocardiography

cardiac function measured by transthoracic echocardiography

cardiac remodeling during pregnancy: number of patients with concentric left ventricular remodeling or concentric hypertrophy.

cardiac remodeling during pregnancy: number of patients with concentric left ventricular remodeling or concentric hypertrophy.

health status of the newborn by Apgar score

prevalence of small for gestational age infancy and prevalence of premature neonates

number of a composite of adverse neonatal outcomes

maternal well-being questionnaire,

number of assessed maternal complications

gestational age at the moment of progression to primary outcome.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- In between 20 and 37 weeks of gestational age;

- Diagnosed with mild to moderate gestational hypertension according to the scientific

definition of mild to moderate hypertension defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP) as systolic blood pressure in between 140-160mmHg and/or diastolic blood pressure in between 90-110mmHg that remains elevated over at least 4 hours, but preferably an overnight rest. 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).

Locations and Contacts

Eva Mulder, MD, Phone: 0031650504243, Email: eva.mulder@mumc.nl

Additional Information

Related 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.

Abalos 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. Review.

Easterling 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.

Valensise 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.

Taler SJ, Textor SC, Augustine JE. Resistant hypertension: comparing hemodynamic management to specialist care. Hypertension. 2002 May;39(5):982-8.

Starting date: September 2015
Last updated: August 21, 2015

Page last updated: August 23, 2015

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