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ID
Source
Brief title
Health condition
- Pregnancy induced hypertension
- Chronic hypertension in pregnancy
- Early-onset pre-eclampsia
- Late-onset pre-eclampsia
Sponsors and support
- Personal grant PI
Intervention
Outcome measures
Primary outcome
Differences in the amount of non-osmotic sodium storage in placental tissue between hypertensive pregnancies (including chronic hypertension, gestational hypertension, late-onset and early-onset pre-eclampsia) and normotensive pregnancies.
Secondary outcome
- Differences in the distribution of non-osmotic sodium storage in placental tissue;
- Differences in the expression of GAGs in placental tissue between hypertensive and normotensive pregnancies.
Background summary
The existing idea about sodium handling in the body postulates that total body sodium is regulated by strict regulation of body fluid. However, recent studies suggest non-osmotic sodium (Na+) storage in the skin. Active Na+ storage independent of volume retention is thought to be facilitated by negatively charged, highly sulfated GAGs which are able to bind Na+ in an osmotically inactive manner and are abundantly expressed in the insterstitium of the skin. Research has shown that high sodium diet increases the non-osmotic Na+ content of the skin and is correlated with the synthesis of new glycosaminoglycans. Furthermore, research has shown that sodium storage in the skin possibly influences blood pressure regulation by mechanisms which involve the immune system. GAGS are also highly expressed in the placenta and are known to have anticoagulant, inflammatory and pro-antigenic properties. Moreover, in previous studies it was found that during PE the amount of GAGs expressed in placental tissue differed when compared to normotensive controls. We previously conducted a pilot experiment in which we found that the placenta may also act as a buffer for non-osmotic sodium storage. Besides we found that in late-onset pre-eclampsia the placenta possibly loses this function. However, this pilot experiment was subjected to several limitations. Therefore, in this prospective cohort study we aim to further investigate a possible role for the placenta as non-osmotic sodium buffer during pregnancy and differences in this ability between normotensive pregnancies and pregnancies complicated by a hypertensive disorder.
This study is designed as a multi-center study (OLVG + Amsterdam UMC – location AMC). After screening for eligibility and given informed consent, additional information will be collected by a questionnaire (printed version or EPIC). Prior to delivery blood plasma will be collected for additional measurements of plasma sodium, osmolality and GAG analysis. Additional information about the pregnancy, the delivery and the newborn will be extracted from the electronic patient file. After delivery the placenta is send to the pathology department of the hospital, where the placental tissue will be analyzed.
Study objective
Like the skin, the placenta is a buffer for non-osmotic sodium storage and acts as an adaptive mechanism to deal with increased sodium. We postulate that pregnancies with a hypertensive disorder will differ in their amount of non-osmotic sodium storage when compared to normotensive pregnancies.
Study design
- Third trimester of pregnancy
- Postpartum
Inclusion criteria
- Aged 18 years or above;
- Uncomplicated pregnancy or hypertensive disorder of pregnancy defined as: pregnancy induced hypertension, chronic hypertension in pregnancy, early-onset pre-eclampsia or late-onset pre-eclampsia;
- Gestational age between 28 weeks to 40 0/7 weeks.
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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7640 |
| CCMO | NL68080.018.18 |
| OMON | NL-OMON48312 |