Clinical trial NCT02807324: Women Specific Cardiac Recovery After Preeclampsia
Official title: Women Specific Cardiac Recovery After Preeclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Pregnancy
HELLP Syndrome
Intrauterine Growth Restriction
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 290
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Controls will be recruited at the outpatient clinic if a planned induction or C-section is indicated due to any obstetric reason other than placental insufficiency or pregnancy related hypertensive disease. Cases will be recruited at the MUMC+, since the current guideline in the Netherlands states that women diagnosed with preeclampsia should be referred to specialist care in the hospital.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The pattern of cardiac recovery
timeFrame: 4 years
Secondary outcomes:
measure: The prevalence of abnormal cardiac findings
timeFrame: 4 years
measure: Overall health and lifestyle - Metabolic syndrome
timeFrame: 4 years
measure: Overall health and lifestyle - Questionnaires
timeFrame: 4 years
measure: Overall health and lifestyle - Microcirculation
timeFrame: 4 years
measure: Overall health and lifestyle - Kidney function
timeFrame: 4 years
measure: VOCs analysis
timeFrame: 4 years
measure: FibroScan
timeFrame: 4 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC+)
Study officials:
affiliation: Maastricht University Medical Center (MUMC+)
name: Marc Spaanderman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: