An observational study in Preeclampsia, Small for Gestational Age at Delivery and HELLP Syndrome, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by Maastricht University Medical Center · Observational
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.
Healthy pregnancy is accompanied by major hemodynamic changes that benefit the uteroplacental circulation. A first-trimester drop in vascular resistance triggers several compensatory mechanisms, amongst an increase in blood volume and cardiac output, to maintain blood pressure. These adaptations continue and stand until delivery.
Women destined to develop gestational hypertensive complications often exhibit deviant hemodynamic adaptation patterns before overt clinical disease. On the one hand, 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.
Antihypertensive therapy based on correction of the hemodynamic imbalance between cardiac output and peripheral resistance seems an effective strategy to improve blood pressure control in hypertensive pregnant women. Even more sophisticated, early treatment of altered cardiac output and peripheral resistance adjustments might prevent development of gestational hypertensive complications. One randomized controlled trial treated pregnant women with an augmented cardiac output with a selective beta-blocker, which resulted in a decreased prevalence of preeclampsia from 18% in the placebo group to 4% in the atenolol group (p = 0.04), at a cost of 440gram birth weight.
In line of this reasoning, the investigators aimed to evaluate early cardiovascular adjustments during pregnancy in a high-risk population (i.e. women with preeclampsia in their first pregnancy). In this health care traject, women with deviant adaptation to pregnancy were advised tailored medication, i.e. beta-blockade in women with an pronounced high cardiac output profile effectuated by a high heart rate, and a vasodilating agent in women with a high-resistance hemodynamic profile. Women with a mixed hemodynamic profile were advised a centrally acting sympatholytic agent. The investigators aimed to retrospectively compare outcome of women attending this health care project with women who received care as usual in their second pregnancy.
903 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 314 is above the median of 160 across 389 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Maastricht University Medical Center is the lead sponsor of 852 studies on the registry; 116 are open to participants now.
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Pregnant women who had preeclampsia in their first pregnancy
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Exclusion Criteria:
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
High-risk women admitted to a non-pregnant cardiovascular and cardiometabolic risk factor assessment who do not participate in the additional follow-up program.
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
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.
Time frame: during pregnancy, or up to 6 weeks after delivery
Number of women that develop HELLP syndrome
HELLP-syndrome is defined as hemolysis (LDH \> 600 U/L), elevated liver enzymes (AST -aspartate aminotransferase- and ALT -alanine aminotransferase- \> 70 U/L) and low platelets (platelet count \< 100.109/L)
Time frame: during pregnancy, or up to 6 weeks after delivery
Number of women that develop eclampsia
Seizures in women with preeclampsia
Time frame: during pregnancy, or up to 6 weeks after delivery
Number of women that have placental abruption during pregnancy
Time frame: During pregnancy or at delivery
Stillbirth
Number of stillbirths in included women
Time frame: during pregnancy until delivery
Neonatal mortality
Number of neonatal demise related to prematurity or as a consequence of maternal disease related to preeclampsia
Time frame: after delivery up to hospital discharge, which is assessed 6 weeks after due date of the mother
Neonatal birth weight
birth weight of neonates
Time frame: measured at delivery
Neonatal birth weight centile
Neonatal birth weight centile (adjusted for sex of neonate, gestational age at delivery and maternal parity)
Time frame: birth weight and other parameters measured at delivery
Pregnancy outcome of women included
Gestational age at delivery
Time frame: at delivery
Plan to share: No
Ran from Nov 2014 to primary completion in Jan 2020, 62 months.
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