Pregnancy Clinical Trial
— PEACHOfficial title:
Exercise and Neurovascular Function During Pregnancy
NCT number | NCT02948439 |
Other study ID # | Pro00061045 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | December 2019 |
Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness of
blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors.
Previous work by the investigators has demonstrated that during pregnancy, the part of the
nervous system responsible for cardiovascular function (the sympathetic nervous system) is
hyperactive. The investigators also know that in women who develop high blood pressure during
pregnancy that sympathetic nervous system activity is even higher. Yet, very little is known
about why this occurs and how this might be affected.
Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient
exercise to meet current guidelines. This is important because hyperactivity of the
sympathetic nervous system is observed in other inactive populations and has been linked to
adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart attack,
and stroke. Indeed, in 2011, the American Heart Association stated that inactivity was a risk
factor as potent as cigarette smoking for the development of future cardiovascular disease in
women.
The investigators' work and others have demonstrated that exercise during pregnancy is
beneficial for both the mom and baby; however, the effect of prenatal exercise on
neurovascular function is not known. If exercise is effective in controlling the increase in
sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular
system, this may help prevent the development of high blood pressure or other cardiovascular
problems during pregnancy.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - >18 years old - singleton pregnancy - cleared to exercise by health care provider using Par Med X for Pregnancy (CSEP) Exclusion Criteria: - multiple gestation - absolute contraindication to exercise (CSEP) - <18 years old - develops any contraindication during intervention |
Country | Name | City | State |
---|---|---|---|
Canada | Program for Pregnancy and Postpartum Health, University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta, Physical Education |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sympathetic Nerve Activity - cold pressor test response | Response of the sympathetic nervous system to cold pressor test (% change in activity) | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Respiratory measures - respiratory frequency | Breathing frequency (breaths per minute). Measured using spirometry. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Sympathetic Nerve Activity - breath hold response | Response of the sympathetic nervous system to voluntary breath hold (% change in activity) | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Respiratory measures - tidal volume | Tidal Volume (Liters per breath). Measured using spirometry. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Respiratory measures - oxygen | Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Respiratory measures - carbon dioxide | Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Respiratory measures - lung volume | Total Lung Capacity (Liters). Measured using spirometry. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Cerebral blood flow at rest | Brain blood flow in the middle cerebral artery at rest (cm/s). Measured using transcranial doppler ultrasound. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Cerebral autoregulation | Brain blood flow in the middle cerebral artery in response to standing (cm/s). Measured using transcranial doppler ultrasound. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Cerebral blood flow during exercise | Brain blood flow in the middle cerebral artery during the acute incremental peak exercise test (cm/s). Measured using transcranial doppler ultrasound. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fasted blood sample - blood volume | Fasted blood samples (~30ml) will be analyzed for markers of blood volume (hematocrit; %) | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fasted blood sample - neurotransmitters | Fasted blood samples (~30ml) will be analyzed for sympathetic nervous system neurotransmitters (Norepinephrine, Epinephrine, Neuropeptide-Y). | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fasted blood sample- inflammatory markers | Fasted blood samples (~30ml) will be analyzed for inflammatory markers (i.e. C-Reactive Protein). | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fasted blood sample- epigenetics | Fasted blood samples (~30ml) will be analyzed for epigenetics (optional). | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fasted blood sample- sex hormones | Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone). | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fasted blood sample- metabolic | Fasted blood samples (~30ml) will be analyzed for metabolic parameters (i.e. glucose) | 16-20 weeks and 34-36 weeks gestation | |
Secondary | fetal outcomes- birth weight | Participants will provide the investigators with birth weight for the infant (grams). | within one month postpartum | |
Secondary | fetal outcomes- length | Participants will provide the investigators with birth length for the infant (cm). | within one month postpartum | |
Secondary | fetal outcomes- gestational age | Participants will provide the investigators with gestational age at delivery (weeks). | within one month postpartum | |
Secondary | maternal outcomes- mode of delivery | Participants will provide the investigators with mode of delivery (vaginal or cesarean). | within one month postpartum | |
Secondary | maternal outcomes- delivery complications | Participants will provide the investigators with information regarding any delivery complications. | within one month postpartum | |
Secondary | maternal outcomes- pregnancy complications | Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia). | any time during study | |
Secondary | fetal outcomes- apgar score | Participants will provide the investigators with APGAR scores (out of 10) for the infant | within one month postpartum | |
Secondary | fetal outcomes- NICU | Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable. | within one month postpartum | |
Secondary | maternal outcomes- gestational weight gain | Participants will provide the investigators with the last maternal weight immediately before delivery. This will be used to calculate gestational weight gain (kg; last maternal weight - self reported pre-pregnancy weight). | within one month postpartum | |
Secondary | Endothelial Function - time to peak dilation | The investigators will assess endothelial function using flow mediated dilation (FMD, time to maximal dilation; s) | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Endothelial Function- flow mediated dilation | The investigators will assess endothelial function using flow mediated dilation (change in diameter; mm) | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Endothelial Function - shear stress | The investigators will assess endothelial function using flow mediated dilation (shear stress; pascals). | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Accelerometry | The investigators will objectively measure physical activity using an accelerometer for one week. Average number of minutes per day spent in various activity levels will be determined. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Physical Activity Questionnaire | The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week). | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Depression rating | Participants will answer a 10-question questionnaire regarding their mood. A score of 10 or higher is indicative of depressive symptoms. The investigators will report the over number of women in each group who have a score of 10+ at the start and end of the intervention. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Sleep Quality | Participants will report their sleep quality using the Pittsburgh Sleep Quality index. A score of 5 or more indicates poor sleep quality. The investigators will compare this score between groups before and after the intervention. | 16-20 weeks and 34-36 weeks gestation | |
Secondary | Food log | The investigators will objectively measure nutrients in diet using a three day food record. This is completed through Food Prodigy/ Food Processor software. | 16-20 weeks and 34-36 weeks gestation |
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