PregnancyPEACHNCT02948439
Prenatal Exercise and Cardiovascular Health (PEACH)
A study testing Aerobic exercise in people with Pregnancy, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old
- singleton pregnancy
- cleared to exercise by health care provider using Par Med X for Pregnancy (CSEP)
Who cannot join
- multiple gestation
- absolute contraindication to exercise (CSEP)
- <18 years old
- develops any contraindication during intervention
Trial locations and contacts
1 site in 1 country.
Canada1 site
Program for Pregnancy and Postpartum Health, University of Alberta
Edmonton, Alberta, T6G 2E1
About this study
Official title: Exercise and Neurovascular Function During Pregnancy
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.
Read the detailed description
The objectives of this study are to: 1) examine the impact of exercise on sympathetic and vascular function during pregnancy; 2) examine the role of endothelial function on the vascular effects of exercise during pregnancy.
Study design:
100 women (>18yrs) will be recruited in the first or second trimester (<20 wks). Women with multiple pregnancies will be excluded. Eligible women will be randomized between an aerobic exercise intervention (EXER) or no intervention (CTRL).
Initial testing will take place between 16-20 weeks of pregnancy. Following initial baseline testing, women will be randomly assigned to an exercise intervention or no intervention. Women will receive an opaque sequentially numbered envelop with their allocation. Allocation will be determined using a randomly generated allocation sequence by an individual not associated with the research study. The intervention will consist of aerobic exercise equivalent to 50-70% of heart rate reserve, 3-4 times per week until the end of the study (34-36 weeks). For initial baseline testing (16-20 weeks) and at the end of the intervention (34-36 weeks), participants will visit the laboratory twice
On Day 1, participants will complete a peak exercise test on the treadmill or bike to volitional fatigue to measures fitness and cardiovascular/cerebrovascular responses to exercise.
On Day 2 Participants will arrive fasted (12 hrs) and blood samples will be collected. Anthropometrics, personal/familial history of hypertension and pregnancy complications will be recorded. Following a standardized breakfast, participants will undergo an assessment of reflex neurovascular control including a cold pressor test, flow mediated dilation and end expiratory voluntary breath hold. Muscle sympathetic nerve activity, ultrasound (blood flow and diameter of brachial, femoral and carotid arteries), blood pressure, heart rate and respiratory variables will be measured.
OUTCOME/IMPACT
Pregnancy is a stress-test for life; with women who develop complications during pregnancy having a higher risk for cardiovascular disease later in life. Exercise is well known to prevent cardiovascular disease through improvements in endothelial function and the sympathetic nervous system. Whether this improvements is also seen in pregnancy remains to be seen.
- Conditions
- Pregnancy
- Being tested
- Aerobic exercise
- Keywords
- pregnancy, cardiovascular, nervous system, exercise
- Medical subject headings
- Neurologic Manifestations, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Also called walking program
Brisk walking 3-4 times per week for up to 40 minutes of activity.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | The aerobic exercise intervention will consist of a walking program at 50-70% of individual heart rate reserve. This will begin at 16-20 weeks gestation and continue 3-4 times per week until the end of the study (34-36 weeks). The duration of exercise will increase each week up to a maximum of 40 minutes (5 min warm up, 25 minutes exercise, 5 min cool down). Women will have at least one supervised exercise session per week. The investigators will also monitor other activity using questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks). Receives: Other: Aerobic exercise |
| Control Group | No intervention | These women will continue regular daily activities. Activity will be monitored periodically with questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic Nerve Activity - cold pressor test response
Response of the sympathetic nervous system to cold pressor test (% change in activity)
Measured: 16-20 weeks and 34-36 weeks gestation
Secondary outcomes (32)
Respiratory measures - respiratory frequency
Breathing frequency (breaths per minute). Measured using spirometry.
Measured: 16-20 weeks and 34-36 weeks gestation
Sympathetic Nerve Activity - breath hold response
Response of the sympathetic nervous system to voluntary breath hold (% change in activity)
Measured: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - tidal volume
Tidal Volume (Liters per breath). Measured using spirometry.
Measured: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - oxygen
Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.
Measured: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - carbon dioxide
Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.
Measured: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - lung volume
Total Lung Capacity (Liters). Measured using spirometry.
Measured: 16-20 weeks and 34-36 weeks gestation
Cerebral blood flow at rest
Brain blood flow in the middle cerebral artery at rest (cm/s). Measured using transcranial doppler ultrasound.
Measured: 16-20 weeks and 34-36 weeks gestation
Cerebral autoregulation
Brain blood flow in the middle cerebral artery in response to standing (cm/s). Measured using transcranial doppler ultrasound.
Measured: 16-20 weeks and 34-36 weeks gestation
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.
Measured: 16-20 weeks and 34-36 weeks gestation
fasted blood sample - blood volume
Fasted blood samples (~30ml) will be analyzed for markers of blood volume (hematocrit; %)
Measured: 16-20 weeks and 34-36 weeks gestation
fasted blood sample - neurotransmitters
Fasted blood samples (~30ml) will be analyzed for sympathetic nervous system neurotransmitters (Norepinephrine, Epinephrine, Neuropeptide-Y).
Measured: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- inflammatory markers
Fasted blood samples (~30ml) will be analyzed for inflammatory markers (i.e. C-Reactive Protein).
Measured: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- epigenetics
Fasted blood samples (~30ml) will be analyzed for epigenetics (optional).
Measured: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- sex hormones
Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).
Measured: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- metabolic
Fasted blood samples (~30ml) will be analyzed for metabolic parameters (i.e. glucose)
Measured: 16-20 weeks and 34-36 weeks gestation
fetal outcomes- birth weight
Participants will provide the investigators with birth weight for the infant (grams).
Measured: within one month postpartum
fetal outcomes- length
Participants will provide the investigators with birth length for the infant (cm).
Measured: within one month postpartum
fetal outcomes- gestational age
Participants will provide the investigators with gestational age at delivery (weeks).
Measured: within one month postpartum
maternal outcomes- mode of delivery
Participants will provide the investigators with mode of delivery (vaginal or cesarean).
Measured: within one month postpartum
maternal outcomes- delivery complications
Participants will provide the investigators with information regarding any delivery complications.
Measured: within one month postpartum
maternal outcomes- pregnancy complications
Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
Measured: any time during study
fetal outcomes- apgar score
Participants will provide the investigators with APGAR scores (out of 10) for the infant
Measured: within one month postpartum
fetal outcomes- NICU
Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable.
Measured: within one month postpartum
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).
Measured: within one month postpartum
Endothelial Function - time to peak dilation
The investigators will assess endothelial function using flow mediated dilation (FMD, time to maximal dilation; s)
Measured: 16-20 weeks and 34-36 weeks gestation
Endothelial Function- flow mediated dilation
The investigators will assess endothelial function using flow mediated dilation (change in diameter; mm)
Measured: 16-20 weeks and 34-36 weeks gestation
Endothelial Function - shear stress
The investigators will assess endothelial function using flow mediated dilation (shear stress; pascals).
Measured: 16-20 weeks and 34-36 weeks gestation
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.
Measured: 16-20 weeks and 34-36 weeks gestation
Physical Activity Questionnaire
The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week).
Measured: 16-20 weeks and 34-36 weeks gestation
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.
Measured: 16-20 weeks and 34-36 weeks gestation
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.
Measured: 16-20 weeks and 34-36 weeks gestation
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.
Measured: 16-20 weeks and 34-36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Skow, MSc, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948439
- Sponsor's protocol ID
- Pro00061045
- Acronym
- PEACH
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2016
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boparai R, Skow RJ, Farooq S, Steinback CD, Davenport MH. Prenatal exercise and cardiovascular health (PEACH) study: the remote effect of aerobic exercise training on conduit artery and resistance vessel function. Appl Physiol Nutr Metab. 2021 Dec;46(12):1459-1468. doi: 10.1139/apnm-2020-0902. Epub 2021 Jun 23.
PubMed 34161737Skow RJ, Fraser GM, Steinback CD, Davenport MH. Prenatal Exercise and Cardiovascular Health (PEACH) Study: Impact on Muscle Sympathetic Nerve (Re)Activity. Med Sci Sports Exerc. 2021 Jun 1;53(6):1101-1113. doi: 10.1249/MSS.0000000000002583.
PubMed 33315812
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Neurovascular Function During Pregnancy
- ClinicalTrials.gov ID
- NCT02948439
- Acronym / sponsor ID
- PEACH / Pro00061045
- Conditions
- Pregnancy
- Keywords
- pregnancy, cardiovascular, nervous system, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objectives of this study are to: 1) examine the impact of exercise on sympathetic and vascular function during pregnancy; 2) examine the role of endothelial function on the vascular effects of exercise during pregnancy.
Study design:
100 women (>18yrs) will be recruited in the first or second trimester (<20 wks). Women with multiple pregnancies will be excluded. Eligible women will be randomized between an aerobic exercise intervention (EXER) or no intervention (CTRL).
Initial testing will take place between 16-20 weeks of pregnancy. Following initial baseline testing, women will be randomly assigned to an exercise intervention or no intervention. Women will receive an opaque sequentially numbered envelop with their allocation. Allocation will be determined using a randomly generated allocation sequence by an individual not associated with the research study. The intervention will consist of aerobic exercise equivalent to 50-70% of heart rate reserve, 3-4 times per week until the end of the study (34-36 weeks). For initial baseline testing (16-20 weeks) and at the end of the intervention (34-36 weeks), participants will visit the laboratory twice
On Day 1, participants will complete a peak exercise test on the treadmill or bike to volitional fatigue to measures fitness and cardiovascular/cerebrovascular responses to exercise.
On Day 2 Participants will arrive fasted (12 hrs) and blood samples will be collected. Anthropometrics, personal/familial history of hypertension and pregnancy complications will be recorded. Following a standardized breakfast, participants will undergo an assessment of reflex neurovascular control including a cold pressor test, flow mediated dilation and end expiratory voluntary breath hold. Muscle sympathetic nerve activity, ultrasound (blood flow and diameter of brachial, femoral and carotid arteries), blood pressure, heart rate and respiratory variables will be measured.
OUTCOME/IMPACT
Pregnancy is a stress-test for life; with women who develop complications during pregnancy having a higher risk for cardiovascular disease later in life. Exercise is well known to prevent cardiovascular disease through improvements in endothelial function and the sympathetic nervous system. Whether this improvements is also seen in pregnancy remains to be seen.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Aerobic exerciseThe aerobic exercise intervention will consist of a walking program at 50-70% of individual heart rate reserve. This will begin at 16-20 weeks gestation and continue 3-4 times per week until the end of the study (34-36 weeks). The duration of exercise will increase each week up to a maximum of 40 minutes (5 min warm up, 25 minutes exercise, 5 min cool down). Women will have at least one supervised exercise session per week. The investigators will also monitor other activity using questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks). |
| Control Group | No intervention | –These women will continue regular daily activities. Activity will be monitored periodically with questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- singleton pregnancy
- cleared to exercise by health care provider using Par Med X for Pregnancy (CSEP)
Key exclusion criteria (4 listed)
- multiple gestation
- absolute contraindication to exercise (CSEP)
- <18 years old
- develops any contraindication during intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAlso: walking programBrisk walking 3-4 times per week for up to 40 minutes of activity. | Other | Exercise Intervention |
Primary outcome
Sympathetic Nerve Activity - cold pressor test response
Time frame: 16-20 weeks and 34-36 weeks gestation
Response of the sympathetic nervous system to cold pressor test (% change in activity)
32 secondary outcomes
Respiratory measures - respiratory frequency
Time frame: 16-20 weeks and 34-36 weeks gestation
Sympathetic Nerve Activity - breath hold response
Time frame: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - tidal volume
Time frame: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - oxygen
Time frame: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - carbon dioxide
Time frame: 16-20 weeks and 34-36 weeks gestation
Respiratory measures - lung volume
Time frame: 16-20 weeks and 34-36 weeks gestation
Cerebral blood flow at rest
Time frame: 16-20 weeks and 34-36 weeks gestation
Cerebral autoregulation
Time frame: 16-20 weeks and 34-36 weeks gestation
Cerebral blood flow during exercise
Time frame: 16-20 weeks and 34-36 weeks gestation
fasted blood sample - blood volume
Time frame: 16-20 weeks and 34-36 weeks gestation
fasted blood sample - neurotransmitters
Time frame: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- inflammatory markers
Time frame: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- epigenetics
Time frame: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- sex hormones
Time frame: 16-20 weeks and 34-36 weeks gestation
fasted blood sample- metabolic
Time frame: 16-20 weeks and 34-36 weeks gestation
fetal outcomes- birth weight
Time frame: within one month postpartum
fetal outcomes- length
Time frame: within one month postpartum
fetal outcomes- gestational age
Time frame: within one month postpartum
maternal outcomes- mode of delivery
Time frame: within one month postpartum
maternal outcomes- delivery complications
Time frame: within one month postpartum
maternal outcomes- pregnancy complications
Time frame: any time during study
fetal outcomes- apgar score
Time frame: within one month postpartum
fetal outcomes- NICU
Time frame: within one month postpartum
maternal outcomes- gestational weight gain
Time frame: within one month postpartum
Endothelial Function - time to peak dilation
Time frame: 16-20 weeks and 34-36 weeks gestation
Endothelial Function- flow mediated dilation
Time frame: 16-20 weeks and 34-36 weeks gestation
Endothelial Function - shear stress
Time frame: 16-20 weeks and 34-36 weeks gestation
Accelerometry
Time frame: 16-20 weeks and 34-36 weeks gestation
Physical Activity Questionnaire
Time frame: 16-20 weeks and 34-36 weeks gestation
Depression rating
Time frame: 16-20 weeks and 34-36 weeks gestation
Sleep Quality
Time frame: 16-20 weeks and 34-36 weeks gestation
Food log
Time frame: 16-20 weeks and 34-36 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 34161737Boparai R, Skow RJ, Farooq S, Steinback CD, Davenport MH. Prenatal exercise and cardiovascular health (PEACH) study: the remote effect of aerobic exercise training on conduit artery and resistance vessel function. Appl Physiol Nutr Metab. 2021 Dec;46(12):1459-1468. doi: 10.1139/apnm-2020-0902. Epub 2021 Jun 23.
- Derived from this study: PubMed 33315812Skow RJ, Fraser GM, Steinback CD, Davenport MH. Prenatal Exercise and Cardiovascular Health (PEACH) Study: Impact on Muscle Sympathetic Nerve (Re)Activity. Med Sci Sports Exerc. 2021 Jun 1;53(6):1101-1113. doi: 10.1249/MSS.0000000000002583.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Skow, MSc study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Pregnancy, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic Nerve Activity - cold pressor test response (time frame: 16-20 weeks and 34-36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948439, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.