We aim to examine the differences in response of hemodynamic and ventilatory parameters between women in their first trimester of pregnancy and non-pregnant women during a CPET.
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in response of cardiac output (*CO) during a CPET, measured with
ICG (by Physioflow), between pregnant and non-pregnant women.
Secondary outcome
Differences in (response of) hemodynamic parameters, ventilation parameters and
aerobic capacity during and after a CPET (measured with ICG, breath-by-breath
analysis, a finger prick blood sampling and a pulse oximeter) between pregnant
women and non-pregnant women. The parameters that will be measured or
calculated are:
- Heart rate
- Blood pressure
- Stroke volume
- Left cardiac function
- Systemic vascular resistance
- Velocity index
- Sensitivity index submaximal (VO2 / stroke volume index)
- Oxygen saturation
- Gas exchange (VO2 and VCO2)
- PetCO2 (End Tidal CO2)
- EqCO2 (Equivalent CO2)
- Anaerobic treshold
- Lactate level in capillary blood
Background summary
Normal pregnancy is characterized by a rise in cardiac output (CO) and a drop
in heart rate (HR) and systemic vascular resistance (SVR) already in the first
trimester of pregnancy, in order to cope with the increased demands of oxygen
and nutrient to allow appropriate growth of a fetus. This cardiac adaptation to
pregnancy can be compared to a nine month lasting moderate exercise. It is
thought that in women who develop placenta-related pregnancy complications
(PPC) an increased risk for cardiovascular disease is unmasked by the stressed
state of pregnancy. To study differences in the cardiovascular adaptation to
pregnancy between women who will or will not develop PPC it is necessary to
gather insight in normal values of hemodynamic parameters in pregnant and
non-pregnant women. A cardiopulmonary exercise test (CPET) is a reliable test
to study the responses of the cardiovascular and respiratory system during
physical stress. Impedance cardiography (ICG) allows continuous, non-invasive
monitoring of several hemodynamic parameters, including cardiac output, stroke
volume and SVR. Physioflow is a device that can be used for ICG and is equipped
with high signal stability. It is therefore very suitable to be used during a
CPET. However the differences in patterns of hemodynamic parameters measured
with ICG during CPET between pregnant women and non-pregnant women have not yet
been investigated.
Study objective
We aim to examine the differences in response of hemodynamic and ventilatory
parameters between women in their first trimester of pregnancy and non-pregnant
women during a CPET.
Study design
A prospective comparative study, conducted at Erasmus University Medical Centre
Rotterdam. There will be no randomisation or blinding.
Study burden and risks
Burden associated with participation exists of one investigation for an
estimated time of 30 minutes. Participants will exercise on a cycle ergometer,
according to a Rapid AccuMulation protocol (RAMP), until their heart rate rises
up to 70% of their maximum heart rate. During the CPET measurements take place,
using ICG, pulse oximeter, blood pressure meter and a breath-by-breath mask.
Before and after the CPET a blood lactate will be assessed, using a single
finger prick. The exercise test will not take place when the participant has
high blood pressure (>140mmHg systolic and/or >90mmHg diastolic) or low oxygen
saturation (<94%) during baseline measurements. The tests and measurements are
validated and are considered safe for pregnant women, their fetus and
non-pregnant women. There is no individual benefit for participants. In case of
any adverse finding women will be referred to specialized care (i.e.
cardiologist, gynaecologist).
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- 20 pregnant women, <13 weeks pregnant
- 20 non-pregnant women
- Age 18-40 years
Exclusion criteria
- Any known pre-existing cardiovascular, respiratory, hypertensive or systemic disorder
- Orthopaedic impairment that compromises exercise performance
- History of placenta-related pregnancy complications (PPC)
- Multiple pregnancy
- Smoking or quit smoking <3 months
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 | NL65204.078.18 |