Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02807324
Other study ID # NL52556.068.15
Secondary ID Local Ethical Co
Status Recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date June 2022

Study information

Verified date August 2018
Source Maastricht University Medical Center
Contact Jolien Oben, MSc
Phone 043 - 38774145
Email jolien.oben@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover, it is known that often the pregnancy induced CV adaptation does not resolve completely after a short postpartum (PP) period and it is not clear whether these induced changes will resolve over a longer period of time (i.e. in the upcoming months/years after delivery). Understanding the cardiac adaptation during pregnancy and the reversal process in the postpartum period, as well as the factors that influence this these processes, may provide us not only insight in this mechanism, but may help us in identifying factors that may be target points for modification.


Description:

The main goal of this study is to explore the pattern of physiologic and pathophysiologic cardiac recovery after a preeclamptic pregnancy compared to a normotensive pregnancy, up till 18 months PP.

This study is a longitudinal cohort study. The first measurement will be performed upon admittance for induction of labour or caesarean section, which corresponds with 48-24 hours before delivery. Further measurements will be performed in clusters at PP intervals of: 24-48 hours, 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 18 months. Cases will also receive an additional baseline measurement upon PE diagnosis.

Cases consist of women with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (early and late PE, with or without intra uterine growth restriction (IUGR)), whereas controls are women with an uncomplicated pregnancy. 290 women in total will be included. Inclusion will of case subjects will occur upon diagnosis, inclusion of controls will occur before delivery.

The first visit of this study will be performed upon admittance after PE diagnosis for cases, and for controls while the participant is administered for the induction of labour or caesarean section, thus an extra visit is not necessary. This is also true for the first postpartum (PP) measurements. The next 6 visits will be after the participant is discharged from the hospital and extra visits are necessary, except for the 6 weeks PP visit, which is a routine visit. The frequent visits may cause some discomfort, especially since our participants are young mothers who still need to take care of their child. During the measurement, one of our co-workers will assist in taking care of the newborn if necessary, so that the participant can bring her child with her. Each of the visits will last approximately 2 hours in the MUMC+. The only invasive procedure is a venapunction where 75 ml blood will be extracted. The only unfavourable side effect can be a small hematoma (rare). Clinically, participants will be advised based on their risk profile following standard "cardiovascular (CV) risk management". Transthoracic echocardiography, glycocalyx measurements and a FibroScan will be performed. Experience shows that this investigation is not experienced as uncomfortable. Also, 3 liters of exhaled air will be collected for VOCs analysis. All measurements will be performed or supervised by an experienced researcher. These investigations are already approved previously in other METC applications (CMO-nr: 2008/226; 2009/004; 10-2-066). The other measurements (questionnaires, blood pressure (BP), weight measurement, urine collection, glycocalyx measurement, FibroScan and exhaled air collection) do not cause any discomfort for the patient besides the time that it takes. On the other hand, potential health improvement and early detection of CV risk profiles and initiation of already existing effective prevention strategies that improve lifestyle are important benefits.

For potential participants who find the number of extra visits too great a burden, a short track version of the study is available with less postpartum visits. the first 3 measurement moments do not differ between both versions. However, after the first PP measurement, 24-48hrs after delivery, they will only have one more additional visit at 12 months PP, but we will include a coronary CTA, an MFD and carotid IMT measurement.


Recruitment information / eligibility

Status Recruiting
Enrollment 290
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women aged = 18 years

- Controls: Women with an uncomplicated pregnancy at the moment of inclusion (i.e no foetal or maternal placental complications, such as pregnancy induced hypertension, preeclampsia or HELLP-syndrome, or small for gestational birth infancies)

- Cases: Women diagnosed with a preeclamptic pregnancy at the moment of inclusion

Exclusion Criteria:

- Women with an auto-immune disease prior to the complicated pregnancy

- Chronic hypertension prior to the complicated pregnancy

- Renal disease prior to the complicated pregnancy

- Women who do not want to be informed about the results of the tests, or women who do not want their general practitioner and specialist(s) to be informed about the test results

Study Design


Intervention

Other:
Venapunction
The only invasive procedure is a venapunction where 75 ml blood will be extracted. The only unfavourable side effect can be a small hematoma (rare).

Locations

Country Name City State
Netherlands Maastricht University Medical Center (MUMC+) Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary The pattern of cardiac recovery The pattern of cardiac recovery in terms of cardiac geometry (measured by relative wall thickness, left ventricular mass and cardiac dimension such as LV end systolic and diastolic diameters, atrial diameters etc..), systolic and diastolic function (measured by ejection fraction (EF%) and E/A ratio) and miRNA expression after a preeclamptic pregnancy compared to a normotensive pregnancy 4 years
Secondary The prevalence of abnormal cardiac findings The prevalence of abnormal cardiac findings amongst participants, such as, Concentric remodeling (based on relative wall thickness (RWT) and LVmass (gr/m2)), left ventricular (LV) hypertrophy (based on LVmass (gr/m2)), LV segmental myocardial impaired relaxation, LV segmental myocardial impaired contractility, Global systolic and diastolic dysfunction (based on ejection fraction (%) and E/A ratio respectively). 4 years
Secondary Overall health and lifestyle - Metabolic syndrome The number of participants with metabolic syndrome (MetS). The MetS is a cluster of risk factors which consists of cardio-metabolic abnormalities (insulin resistance and/or impaired glucose tolerance, low high density lipoprotein (HDL) cholesterol, high triglycerides (TG)) and cardiovascular mechanical stress indicators (elevated BP, micro albuminuria, obesity). We will define the MetS based on The World Health Organisation (WHO) criteria. It consists of impaired glucose regulation, diabetes mellitus or insulin resistance with at least two of the following criteria: Elevated TG (=1.7 nmol/l) or reduced HDL-cholesterol (< 1.0 mmol/l),Elevated BP (=140/85mmHg), Central obesity (waist-hip ratio > 0.85 or BMI > 30 kg/m2), Micro-albuminuria (> 0.30 g/mmol creatinine) 4 years
Secondary Overall health and lifestyle - Questionnaires The prevalence of cardiovascular risk factors amongst participants (determined via questionnaires).The questionnaires contains questions about daily exercise, eating and drinking habits (mainly the consumption of fruits and vegetables), and smoking/alcohol/drugs consumption. Lifestyle is known to affect the risk for CVD.By exploring lifestyle factors in both subjects and controls, we will be able to determine the (confounding) contributio of lifestyle factors for the increased risk of CVD after PE. Consequently, we will be able to study the contribution of PE independent of lifestyle on the development of CVD. 4 years
Secondary Overall health and lifestyle - Microcirculation The number of participants with an increased perfused boundary region (PBR), as measures with Glycocheck. The main read-out parameter of the glycocheck machine is the perfused boundary region (PBR). In short, the endothelial glycocalyx constitutes a protective barrier for the vessel wall, which limits the proximity of erythrocytes to the endothelial cells in the microvasculature, causing the PBR to be small in healthy conditions. In contrast, perturbation of the glycocalyx allows deeper cell penetration into the glycocalyx, leading to an increase in PBR. Monitoring of the PBR, therefore, gives information about the barrier properties of the glycocalyx and the state of the microvascular system. 4 years
Secondary Overall health and lifestyle - Kidney function The number of participants with a decreased kidney function, measured by abnormal lab values of a urine sample, such as total protein, creatinine and micro-albumin. 4 years
Secondary VOCs analysis The highest discriminative pattern of VOCs (Volatile Oxidized Compounds) between PE patients, HELLP syndrome patients, PE + HELLP syndrome patients and healthy control pregnancies. 4 years
Secondary FibroScan Differences in metabolism, liver stiffness, fibrosis and steatosis of the liver between PE patients, HELLP syndrome patients, PE + HELLP syndrome patients and healthy control pregnancies at the time of diagnosis and over time. 4 years
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Completed NCT02528136 - The Clinical Carbetocin Myocardium Trial Phase 4