The main goal is to investigate if non-osmotic sodium storage in placental tissue, analogous with the skin, is harmful and associated with hypertensive disorders in pregnancy.
ID
Source
Brief title
Condition
- Placental, amniotic and cavity disorders (excl haemorrhages)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The chief parameter we will be studying is the difference in the amount of
non-osmotic sodium storage in placental tissue, defined as sodium content per
dry weight, between placentas of hypertensive pregnancies and normotensive
pregnancies.
Secondary outcome
• The distribution of non-osmotic sodium storage in placental tissue;
• The difference in GAG expression.
Background summary
Non-osmotic sodium storage by glycosaminoglycans (GAGs) in the skin
interstitium and the endothelial surface layer (ESL) is a novel concept. It
reveals that the existing idea about sodium homeostasis in the body is more
difficult then we have considered it to be for years. Negatively charged,
highly sulfated glycosaminoglycans are able to bind sodium in an osmotically
inactive manner. These GAGs are abundantly expressed in the skin insterstitium
and the endothelial surface layer (ESL) and are covalent attached to
proteoglycans. Research have shown that high sodium diet both increases ESL
stiffness as the sodium content of the skin. In humans, high sodium skin
content is associated with a variety of pathological conditions, such as
hypertension and chronic kidney disease. GAGs are also highly expressed in the
placenta and have known anticoagulant, inflammatory and pro-antigenic
properties. Despite an increased understanding of the roles of placental GAGs
in the extracellular matrix, it is unknown if these GAGs contribute to
non-osmotic sodium storage and if non-osmotic sodium storage differs between
normotensive pregnancies and pregnancies complicated by a hypertensive
disorder.
Study objective
The main goal is to investigate if non-osmotic sodium storage in placental
tissue, analogous with the skin, is harmful and associated with hypertensive
disorders in pregnancy.
Study design
This study is designed as a multi-center(OLVG + AMC) case-control study. After
screening for eligibility patients are informed about the study and ask for
informed consent. After given informed consent all subjects will fill in a
questionnaire to collect information regarding demographic characteristics,
medical history, co-morbidity, medication usage and obstetric history. Medical
information about the current pregnancy, the delivery and the new born will be
extracted from the electronic patient file. Prior to delivery two extra vials
of blood will be collected for additional measurements of plasma sodium,
osmolality and GAG analysis. The placenta is send to the pathology department
of the hospital. Biopsies are taken for specific regions of the placenta. Water
content, electrolyte concentrations and GAGs expression are measured in all
biopsies.
Study burden and risks
The results of this study are beneficial to our understanding of the placenta
as non-osmotic buffer for sodium storage and the role of non-osmotic sodium
storage in hypertensive disorders of pregnancy. The burden and risks of
participation are negligible, considering the placenta as a waste product after
child-birth. There is no individual benefit from participation in this study.
There is no individual benefit from participation in this study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Pregnant women aged >= 18 years with a hypertensive disorder of pregnancy (pre-eclampsia, HELLP syndrome, gestational hypertension, chronic hypertension in pregnancy)
- Gestational age between 28 weeks to 40 0/7 weeks;
- Healthy subjects should be aged >= 18 years, normotensive during the whole pregnancy and matched for gestational age.
Exclusion criteria
- Pregnant women aged <18 years;
- Pregnant women with multiple pregnancies;
- Diagnosis of end stage renal disease;
- Medical history of diabetic disease;
- Presence of a known congenital anomaly;
- Presence of congenital infections;
- Unwillingness to participate in the study or to cede the placenta after delivery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68080.018.18 |
| OMON | NL-OMON27314 |