The aim of this study is to determine functional parameters of the maternal heart during the lactation period by echocardiography and to correlate these functional parameters with circulating hormones.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine Echocardiography parameters to be obtained will include LVEF, left
ventricular dimensions, left ventricular mass index, septal wall thickness,
posterior wall thickness, systolic function), LV mass, left atrial (LA) volume
and e*. If available, other echocardiographic parameters, including right
atrial dimensions, parameters of diastolic dysfunction (i.e., E, A, E/A ratio,
deceleration time, e* and E/e* ratio) and valve (dys)function will also be
evaluated.
- to obtain a descriptive biomarker profile of women during and after
pregnancy, but especially to differentiate lactating women from non-lactating
women.
- Proteomics will be used to determine unbiased profiles pertaining to
circulating factors in the collected blood samples
Secondary outcome
-The serum collected will be added to culturing conditions of in vitro models
that are used as surrogates for the human heart. These models are based on
cultured cardiomyocytes that have been generated from pluripotent stem cells.
In these in vitro studies, gene expression, protein expression, cell size, and
metabolic function will be determined as functional parameters. These cells
have been obtained as part of a previous study for which ethical approval was
given (METc2014/104).
Background summary
Pregnancy poses a stress test for the maternal heart and is associated with
various physiological changes over the course of pregnancy and during
lactation. For example, blood volume increases significantly which leads to
volume overload for the heart and subsequent cardiac hypertrophy and
angiogenesis. Hormones drive metabolic switches in almost all organs. It is
unknown how these challenges affect the maternal heart and how quickly these
effects dissipate after delivery.
Study objective
The aim of this study is to determine functional parameters of the maternal
heart during the lactation period by echocardiography and to correlate these
functional parameters with circulating hormones.
Study design
This observational study pertains to healthy women during pregnancy and after
delivery.
Group 1: Breastfeeding participants after delivery
Group 2: Participants who are not breastfeeding after delivery.
Study burden and risks
Participants will be invited to visit the UMCG at four to five different times
for echocardiography and collection of blood.
These visits will be scheduled for the nursing group at gestational week 20
and, week 36-38, 10 weeks postpartum and when breastfeeding is stopped
postpartum, and 10 weeks after cessation of lactation.
The control group will be invited for visits at gestational week 20 and week
36-38, 10 weeks postpartum, and 6 months postpartum.
There are no risks associated with echocardiography and venipuncture may cause
minor discomfort at the time of blood collection and may result in minor
hematoma formation, this is seen as negligible risk.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Inclusion criteria
- Ages between 18 * 40 years.
- Healthy pregnant women.
- Parity under or equal to 2 (no more than 2 previous advanced pregnancies)
Exclusion criteria
- Complications during current pregnancy or during a previous pregnancy that
may affect the current pregnancy including HELLP syndrome and pre-eclampsiaia.
- Twin pregnancy.
- Use of prescribed medication.
- Unable to understand study procedures.
- Unable or unwilling to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79238.042.21 |