Women Specific Cardiac Recovery After Preeclampsia

NCT02807324 | Unknown DMC

• 2 other identifiers: NL52556.068.15Local Ethical Commission
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia; Pregnancy; HELLP Syndrome; Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The prevalence of abnormal cardiac findings

  4 years

• Overall health and lifestyle - Metabolic syndrome

  4 years

• Overall health and lifestyle - Questionnaires

  4 years

• Overall health and lifestyle - Microcirculation

  4 years

• Overall health and lifestyle - Kidney function

  4 years

Study Arms (6)

Controls

Controls are women (18 years or older) with an uncomplicated pregnancy (i.e no foetal or maternal placental complications, such as pregnancy induced hypertension, preeclampsia or HELLP-syndrome, or small for gestational birth infancies)

Other: Venapunction

Early PE with IUGR

These cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivides in early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).

Other: Venapunction

Early PE without IUGR

Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivides in early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).

Other: Venapunction

Late PE with IUGR

Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivides in early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).

Other: Venapunction

Late PE without IUGR

Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivides in early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).

Other: Venapunction

HELLP syndrome

Cases consist of women (18 years or older) with HELLP syndrome in the current pregnancy (defined as (1) the presence of microangiopathic hemolytic anemia with abnormal blood smear, low serum haptoglobin and elevated lactate dehydrogenase (LDH) levels, (2) aspartate transaminase (ASAT) above 70 IU/L and lactate dehydrogenase (LD) above 600 IU/L or bilirubin more than 1.2 mg/dL, (3) platelet count below 100 x 10\^9 L-1 )

Other: Venapunction

Interventions

Venapunction OTHER

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).

Controls; Early PE with IUGR; Early PE without IUGR; HELLP syndrome; Late PE with IUGR; Late PE without IUGR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women aged ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center (MUMC+)

Maastricht, 6202 AZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for microRNA analyses

MeSH Terms

Conditions

Pre-Eclampsia; HELLP Syndrome; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Spaanderman, MD, PhD

  Maastricht University Medical Center (MUMC+)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolien Oben, MSc

CONTACT

043 - 38774145; jolien.oben@gmail.com

Marc Spaanderman, MD. PhD

CONTACT

043 - 38774774; marc.spaanderman@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 27, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)