Early Vascular Adjustments to Prevent Preeclampsia

NCT04216706 | Completed

• 1 other identifier: 14-4-118
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

Women destined to develop gestational hypertensive complications often exhibit deviant hemodynamic adaptation patterns before overt clinical disease. Gestational hypertension and late onset preeclampsia are associated with an exaggerated rise in cardiac output on top of a higher prepregnant value, whereas a shallow rise in cardiac output and the lack of a peripheral resistance drop predisposes to the much less common early onset-preeclampsia along with impaired fetal growth. Early treatment of altered cardiac output and peripheral resistance adjustments might prevent development of gestational hypertensive complications. The investigators aim to evaluate early cardiovascular adjustments during pregnancy in a high-risk population, and to pharmaceutically adjust deviant cardiovascular adaptations with beta-blockade, centrally acting sympatholytic agents or vasodilating agents when appropriate to prevent adverse effects on neonatal birth weight.

Conditions

Preeclampsia; Small for Gestational Age at Delivery; HELLP Syndrome

Keywords

cardiac output; total peripheral vascular resistance; hemodynamic parameters; adaptation to pregnancy; tailored treatment

Outcome Measures

Primary Outcomes (1)

• Number of women that develop preeclampsia

  Preeclampsia is defined as new-onset hypertension along with de novo proteinuria or other maternal organ dysfunction (i.e. renal insufficiency, liver involvement, neurological complications or hematological complications) after 20 weeks of gestation in previously normotensive women, or superimposed on chronic hypertension.

  during pregnancy, or up to 6 weeks after delivery

Secondary Outcomes (8)

• Number of women that develop HELLP syndrome

  during pregnancy, or up to 6 weeks after delivery

• Number of women that develop eclampsia

  during pregnancy, or up to 6 weeks after delivery

• Number of women that have placental abruption during pregnancy

  During pregnancy or at delivery

• Stillbirth

  during pregnancy until delivery

• Neonatal mortality

  after delivery up to hospital discharge, which is assessed 6 weeks after due date of the mother

Study Arms (2)

Tailored treatment advise in suboptimal adaptation

High-risk women admitted to a non-pregnant cardiovascular and cardiometabolic risk factor assessment are invited to participate in a follow-up program at four time-points during a subsequent pregnancy (i.e. at 12, 16, 20 and 30 weeks of gestational age). This program is additive to regular pregnancy check-ups, and all women are otherwise managed by their referring physicians. The aim of this program is to evaluate adaptation of maternal hemodynamic parameters in response to pregnancy, and to adjust deviant adaptation with tailored antihypertensive medication. Participation in this program is on voluntary basis, and not restricted to severity of complications in the first pregnancy.

Drug: tailored pharmaceutical treatment

Care as usual during pregnancy

High-risk women admitted to a non-pregnant cardiovascular and cardiometabolic risk factor assessment who do not participate in the additional follow-up program.

Interventions

tailored pharmaceutical treatment DRUG

Tailored medication is advised in women with inadequate hemodynamic adaptation to pregnancy. Type of medication depends on total peripheral vascular resistance and heart rate. In short, women with a low peripheral vascular resistance in parallel with a high heart rate are advised a betablocker (labetalol), while a vasodilating agent (calcium channel blocker, nifedipine) was advised in women with a high total peripheral vascular resistance in combination with a low heart rate. Women with suboptimal adaptation to pregnancy without an extreme pronounced vascular profile are advised a centrally acting sympatholytic agent (methyldopa).

Also known as: Betablocker, Centrally acting sympatholytic agent, Calcium channel blocker

Tailored treatment advise in suboptimal adaptation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who had preeclampsia in their first pregnancy

You may qualify if:

• first pregnancy complicated by preeclampsia
• admitted to an extensive non-pregnant cardiovascular and metabolic risk factor assessment

You may not qualify if:

• women without an ongoing pregnancy after 24 weeks' gestational age

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Netherlands

Location

Related Publications (1)

• Mulder EG, Ghossein-Doha C, Cauffman E, Lopes van Balen VA, Schiffer VMMM, Alers RJ, Oben J, Smits L, van Kuijk SMJ, Spaanderman MEA. Preventing Recurrent Preeclampsia by Tailored Treatment of Nonphysiologic Hemodynamic Adjustments to Pregnancy. Hypertension. 2021 Jun;77(6):2045-2053. doi: 10.1161/HYPERTENSIONAHA.120.16502. Epub 2021 Apr 5.

  PMID: 33813842 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; HELLP Syndrome

Interventions

Calcium Channel Blockers

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 3, 2020
• Study Start: November 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)