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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR017944-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this trial is to determine whether a stretching intervention is superior to a usual care control condition (moderate/vigorous activity 30 minutes daily, 5 days per week) for pregnant women from 27 to 37 gestational weeks.
Although being sedentary can lead to excess risk for maternal and child mortality and morbidity, most pregnant women reduce their physical activity and only 8% meet the recommendations in the 3rd trimester.
In a prior randomized control trial, it was found that fewer women who stretched developed preeclampsia than did women who walked (3/60 "stretchers" vs. 10/64 "walkers", p=.05).
In this study, participants will either receive a stretching intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Experimental | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group. |
|
| Usual Care (Control) | No Intervention | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretching Exercise Intervention | Behavioral | Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
| Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 37 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
| Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks) Three total measurements will be taken, the first will be removed and the second two averaged. | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
| Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeonAe Yeo, PhD, FAAN | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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224 participants consented during early pregnancy. After consenting, participants underwent a run-in period until reaching approximately 27 weeks gestation, at which point a baseline visit was scheduled. 108 participants completed this baseline visit, and thus were randomized to one of the study arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prenatal Heart Smart Intervention | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group. Stretching Exercise Intervention: Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions. |
| FG001 | Usual Care (Control) | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prenatal Heart Smart Intervention | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group. Stretching Exercise Intervention: Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged. | Only includes participants who completed blood pressure measures at their 32 week follow-up visit. | Posted | Mean | Standard Deviation | mmHg | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
|
From the time of randomization (about 27 weeks gestation) through 8 weeks after delivery, an approximate total of 21 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prenatal Heart Smart Intervention | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, the group will complete a sequential static stretching exercise 5 days per week for 10 weeks. The stretching exercise consists of 20 seconds of stretching, for 3 repetitions per muscle group. Stretching Exercise Intervention: Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Preeclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath while exercising | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Crandell, PhD | University of North Carolina at Chapel Hill | 919-966-5803 | jcrandell@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Original version | Dec 10, 2024 | Apr 25, 2025 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Revised version to remove Cardiac Impedance measures | Oct 23, 2025 | Oct 30, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2021 | Jul 12, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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A parallel design will be used, with an equal allocation of 306 obese pregnant women to the two groups: stretching exercise and enhanced usual care.
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Masking will not be completed in this trial.
| Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
| Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic Activity From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | The time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 32 gestational weeks. | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
| Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | The time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 37 gestational weeks. | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
| Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | High frequency of heart rate variability (log(ms^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks. | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
| Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | High frequency of heart rate variability (log(ms^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks. | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
| Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness. | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
| Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness. | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
| Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy |
Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. |
| Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy | Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Preterm Delivery at End of Pregnancy | Presence of preterm delivery in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Elective or Emergency Cesarean Section at End of Pregnancy | Presence of an elective or emergency cesarean section in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Composite Score of Maternal Outcomes at the End of Pregnancy | The composite score of maternal outcomes (onset of preeclampsia, eclampsia pregnancy induced hypertension, gestational diabetes, preterm delivery, and elective or emergency cesarean section) is obtained at the end of pregnancy. Scores range from 0-6, with higher scores indicating a less healthy pregnancy. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Intrauterine Death at End of Pregnancy | Presence of an intrauterine death in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Child Being Small for Gestational Age at the End of Pregnancy | Presence of the child being small for gestational age in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Child Being Large for Gestational Age at the End of Pregnancy | Presence of the child being large for gestational age in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Neonatal Intensive Care Unit Admission at the End of Pregnancy | Presence of a neonatal intensive care unit admission in the electronic medical record. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. | The composite score of fetal/neonatal outcomes (intrauterine death, child being small, child being large, neonatal intensive care admission) is obtained at the end of pregnancy. Scores range from 0-4, with higher scores indicating a less healthy fetus/neonate. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
| BG001 | Usual Care (Control) | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Usual Care (Control) | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. |
|
|
| Primary | Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Average systolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 37 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged. | Only includes participants who completed blood pressure measures at their 37 week follow-up visit. | Posted | Mean | Standard Deviation | mmHg | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
|
|
|
| Primary | Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 5 weeks after baseline (approximately 32 gestational weeks) Three total measurements will be taken, the first will be removed and the second two averaged. | Only includes participants who completed blood pressure measures at their 32 week follow-up visit. | Posted | Mean | Standard Deviation | mmHg | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
|
|
|
| Primary | Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Average diastolic blood pressure measurement between two measurements, assessed at baseline (approximately 27 gestational weeks) and approximately 10 weeks after baseline (approximately 32 gestational weeks). Three total measurements will be taken, the first will be removed and the second two averaged. | Only includes participants who completed blood pressure measures at their 37 week follow-up visit. | Posted | Mean | Standard Deviation | mmHg | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
|
|
|
| Primary | Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic Activity From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | The time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 32 gestational weeks. | This variable required cardiac impedance data, which were not collected from any participants. PEP was initially proposed as a measure of autonomic function; however, we were already collecting high-frequency (HF) heart rate variability, a more well-established indicator of autonomic function. Adding another measure was deemed an unnecessary burden on participants, so it was removed from the protocol. | Posted | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
|
|
| Primary | Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | The time in milliseconds from the ECG R point (left ventricular depolarization) and the B-point on the Dz/dt wave form (opening of the aortic valve), assessed at baseline (27 gestational weeks) and 37 gestational weeks. | This variable required cardiac impedance data, which were not collected from any participants. PEP was initially proposed as a measure of autonomic function; however, we were already collecting high-frequency (HF) heart rate variability, a more well-established indicator of autonomic function. Adding another measure was deemed an unnecessary burden on participants, so it was removed from the protocol. | Posted | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
|
|
| Primary | Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | High frequency of heart rate variability (log(ms^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 32 gestational weeks. | Only includes participants who completed heart rate variability measures at their 32 week follow-up visit. | Posted | Mean | Standard Deviation | log(ms^2/Hz) | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
|
|
|
| Primary | Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | High frequency of heart rate variability (log(ms^2/Hz)) from an electrocardiogram, assessed at baseline (27 gestational weeks) and 37 gestational weeks. | Only includes participants who completed heart rate variability measures at their 37 week follow-up visit. | Posted | Mean | Standard Deviation | log(ms^2/Hz) | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
|
|
|
| Primary | Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness. | Only includes participants who completed PWV measures at their 32 week follow-up visit. | Posted | Mean | Standard Deviation | m/s | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks) |
|
|
|
| Primary | Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Carotid-femoral pulse wave velocity (PWV) is a measure of arterial stiffness reported in m/s. Lower values reflect less arterial stiffness. | Only includes participants who completed PWV measures at their 37 week follow-up visit. | Posted | Mean | Standard Deviation | m/s | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks) |
|
|
|
| Secondary | Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy | Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Preterm Delivery at End of Pregnancy | Presence of preterm delivery in the electronic medical record. | Only includes babies delivered within the hospital system to which the study team had record access, or where the mother provided basic delivery information to the study team post-delivery. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Elective or Emergency Cesarean Section at End of Pregnancy | Presence of an elective or emergency cesarean section in the electronic medical record. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Composite Score of Maternal Outcomes at the End of Pregnancy | The composite score of maternal outcomes (onset of preeclampsia, eclampsia pregnancy induced hypertension, gestational diabetes, preterm delivery, and elective or emergency cesarean section) is obtained at the end of pregnancy. Scores range from 0-6, with higher scores indicating a less healthy pregnancy. | Only includes babies delivered within the hospital system to which the study team had record access, or where the mother provided basic delivery information to the study team post-delivery. | Posted | Mean | Standard Deviation | score on a scale | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Intrauterine Death at End of Pregnancy | Presence of an intrauterine death in the electronic medical record. | Only includes babies delivered within the hospital system to which the study team had record access. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Child Being Small for Gestational Age at the End of Pregnancy | Presence of the child being small for gestational age in the electronic medical record. | Only includes babies delivered within the hospital system to which the study team had record access. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Child Being Large for Gestational Age at the End of Pregnancy | Presence of the child being large for gestational age in the electronic medical record. | Only includes babies delivered within the hospital system to which the study team had record access. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Neonatal Intensive Care Unit Admission at the End of Pregnancy | Presence of a neonatal intensive care unit admission in the electronic medical record. | Only includes babies delivered within the hospital system to which the study team had record access. | Posted | Count of Participants | Participants | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| Secondary | Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. | The composite score of fetal/neonatal outcomes (intrauterine death, child being small, child being large, neonatal intensive care admission) is obtained at the end of pregnancy. Scores range from 0-4, with higher scores indicating a less healthy fetus/neonate. | Only includes babies delivered within the hospital system to which the study team had record access. | Posted | Mean | Standard Deviation | score on a scale | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks |
|
|
|
| 0 |
| 53 |
| 5 |
| 53 |
| 35 |
| 53 |
| EG001 | Usual Care (Control) | This group will have usual care completed and supportive calls from a facilitator to discuss adherence to the home exercise. In addition, this group will complete moderate-intensity walking 5 days per week for 10 weeks in accordance to usual care. | 0 | 55 | 8 | 55 | 41 | 55 |
| Hospitalization for Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Fetal abnormality (abdominal mass) detected via ultrasound | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Dizziness while exercising | Cardiac disorders | Non-systematic Assessment |
|
| Reported contracting respiratory virus (cold, flu, RSV, or Covid) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Gastrointestinal virus | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pregnancy-related pain or soreness | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Includes hip pain, sciatica, back pain, abdominal soreness |
|
| Delivery via Caesarean section | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |