Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
250

Summary

Conditions
  • HELLP Syndrome
  • Intrauterine Growth Restriction
  • Pre Eclampsia
  • Pregnancy
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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...

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.

Tracking Information

NCT #
NCT02807324
Collaborators
Not Provided
Investigators
Principal Investigator: Marc Spaanderman, MD, PhD Maastricht University Medical Center (MUMC+)