Pregnancy Related, Cardiovascular Risk Factor, Obesity
Conditions
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALStretching 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.
Sponsors
National Institute of Nursing Research (NINR)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking will not be completed in this trial.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant at less than 24 weeks gestation * Singleton pregnancy * BMI ≥ 30 kg/m\^2 at their first prenatal care visit * English or Spanish speaking
Exclusion criteria
* Women who expect or are scheduled to deliver prior to 37 weeks gestation * Women who expect to move from the area during their participation in the study * Women who are unable to exercise for 30 or more minutes 3 times per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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. |
| Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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. |
| Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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. |
| Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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. |
| Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic Activity From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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. |
| Change in Sympatho-vagal Balance Projection Period (PEP) for Sympathetic From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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. |
| Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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. |
| Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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. |
| Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 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. |
| Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Intensive Care Unit Admission at the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of a neonatal intensive care unit admission in the electronic medical record. |
| Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of preeclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. |
| Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | 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. |
| Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of eclampsia anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. |
| Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of pregnancy induced hypertension anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. |
| Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of gestational diabetes anytime between baseline (27 weeks gestation) and the end of pregnancy in the electronic medical record. |
| Preterm Delivery at End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of preterm delivery in the electronic medical record. |
| Elective or Emergency Cesarean Section at End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of an elective or emergency cesarean section in the electronic medical record. |
| Composite Score of Maternal Outcomes at the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | 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. |
| Intrauterine Death at End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of an intrauterine death in the electronic medical record. |
| Child Being Small for Gestational Age at the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of the child being small for gestational age in the electronic medical record. |
| Child Being Large for Gestational Age at the End of Pregnancy | Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks | Presence of the child being large for gestational age in the electronic medical record. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 55 |
| Total | 108 |
Baseline characteristics
| Characteristic | Prenatal Heart Smart Intervention | Total | Usual Care (Control) |
|---|---|---|---|
| Age, Continuous | 32.8 years STANDARD_DEVIATION 3.7 | 31.9 years STANDARD_DEVIATION 4.9 | 31.0 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 17 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 85 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 41 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 24 Participants | 51 Participants | 27 Participants |
| Region of Enrollment United States | 53 Participants | 108 Participants | 55 Participants |
| Sex: Female, Male Female | 53 Participants | 108 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 55 |
| other Total, other adverse events | 35 / 53 | 41 / 55 |
| serious Total, serious adverse events | 5 / 53 | 8 / 55 |
Outcome results
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)
Population: Only includes participants who completed PWV measures at their 32 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | 0.20 m/s | Standard Deviation 1.81 |
| Usual Care (Control) | Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | 0.19 m/s | Standard Deviation 0.78 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)
Population: Only includes participants who completed PWV measures at their 37 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | 0.07 m/s | Standard Deviation 1.34 |
| Usual Care (Control) | Change in Arterial Stiffness Assessed by SphygmoCor XCEL From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | 0.59 m/s | Standard Deviation 0.99 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)
Population: Only includes participants who completed blood pressure measures at their 32 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | 0.41 mmHg | Standard Deviation 7.75 |
| Usual Care (Control) | Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | 1.42 mmHg | Standard Deviation 5.28 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)
Population: Only includes participants who completed blood pressure measures at their 37 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | 4.52 mmHg | Standard Deviation 7.08 |
| Usual Care (Control) | Change in Diastolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | 7.63 mmHg | Standard Deviation 7.27 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)
Population: Only includes participants who completed heart rate variability measures at their 32 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | -0.13 log(ms^2/Hz) | Standard Deviation 1.42 |
| Usual Care (Control) | Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | -0.03 log(ms^2/Hz) | Standard Deviation 1.48 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)
Population: Only includes participants who completed heart rate variability measures at their 37 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | -0.42 log(ms^2/Hz) | Standard Deviation 1.02 |
| Usual Care (Control) | Change in High Frequency of Heart Rate Variability From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | -0.37 log(ms^2/Hz) | Standard Deviation 1.27 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)
Population: 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.
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)
Population: 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.
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 5 weeks after baseline (approximately 32 gestational weeks)
Population: Only includes participants who completed blood pressure measures at their 32 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | 0.73 mmHg | Standard Deviation 8.21 |
| Usual Care (Control) | Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 32 Gestational Weeks | -1.56 mmHg | Standard Deviation 8.34 |
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.
Time frame: Baseline (approximately 27 gestational weeks) to approximately 10 weeks after baseline (approximately 37 gestational weeks)
Population: Only includes participants who completed blood pressure measures at their 37 week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | 3.14 mmHg | Standard Deviation 8.02 |
| Usual Care (Control) | Change in Systolic Blood Pressure From Baseline (27 Gestational Weeks) to 37 Gestational Weeks | 6.23 mmHg | Standard Deviation 10.07 |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: Only includes babies delivered within the hospital system to which the study team had record access.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Child Being Large for Gestational Age at the End of Pregnancy | 7 Participants |
| Usual Care (Control) | Child Being Large for Gestational Age at the End of Pregnancy | 11 Participants |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: Only includes babies delivered within the hospital system to which the study team had record access.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Child Being Small for Gestational Age at the End of Pregnancy | 2 Participants |
| Usual Care (Control) | Child Being Small for Gestational Age at the End of Pregnancy | 5 Participants |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: Only includes babies delivered within the hospital system to which the study team had record access.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. | 0.20 score on a scale | Standard Deviation 0.4 |
| Usual Care (Control) | Composite Score of Fetal/Neonatal Outcomes at the End of Pregnancy. | 0.32 score on a scale | Standard Deviation 0.47 |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prenatal Heart Smart Intervention | Composite Score of Maternal Outcomes at the End of Pregnancy | 0.90 score on a scale | Standard Deviation 1.12 |
| Usual Care (Control) | Composite Score of Maternal Outcomes at the End of Pregnancy | 1.00 score on a scale | Standard Deviation 1.05 |
Secondary
Elective or Emergency Cesarean Section at End of Pregnancy
Presence of an elective or emergency cesarean section in the electronic medical record.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Elective or Emergency Cesarean Section at End of Pregnancy | 18 Participants |
| Usual Care (Control) | Elective or Emergency Cesarean Section at End of Pregnancy | 18 Participants |
Secondary
Intrauterine Death at End of Pregnancy
Presence of an intrauterine death in the electronic medical record.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: Only includes babies delivered within the hospital system to which the study team had record access.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Intrauterine Death at End of Pregnancy | 0 Participants |
| Usual Care (Control) | Intrauterine Death at End of Pregnancy | 0 Participants |
Secondary
Neonatal Intensive Care Unit Admission at the End of Pregnancy
Presence of a neonatal intensive care unit admission in the electronic medical record.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: Only includes babies delivered within the hospital system to which the study team had record access.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Neonatal Intensive Care Unit Admission at the End of Pregnancy | 1 Participants |
| Usual Care (Control) | Neonatal Intensive Care Unit Admission at the End of Pregnancy | 1 Participants |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | 0 Participants |
| Usual Care (Control) | Onset of Eclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | 0 Participants |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy | 6 Participants |
| Usual Care (Control) | Onset of Gestational Diabetes Anytime Between Baseline (27 Weeks) and the End of Pregnancy | 6 Participants |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | 4 Participants |
| Usual Care (Control) | Onset of Preeclampsia Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | 7 Participants |
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.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | 15 Participants |
| Usual Care (Control) | Onset of Pregnancy Induced Hypertension Anytime Between Baseline (27 Weeks Gestation) and the End of Pregnancy | 21 Participants |
Secondary
Preterm Delivery at End of Pregnancy
Presence of preterm delivery in the electronic medical record.
Time frame: Baseline (approximately 27 Weeks Gestation) to the End of Pregnancy (approximately 40 weeks); approximately 13 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prenatal Heart Smart Intervention | Preterm Delivery at End of Pregnancy | 3 Participants |
| Usual Care (Control) | Preterm Delivery at End of Pregnancy | 2 Participants |