PregnancyNCT01970436
Personalized Prenatal Care for Low-Risk Pregnancies Using Telemedicine
A study testing Remote Prenatal Care in people with Pregnancy, run by University of Utah at 1 site in United States.
Trial summary
Not all pregnant women have the same risks for pregnancy complications. Women at low-risk for pregnancy complications may not need the same type of prenatal care. The goal of this study is to learn about the use of telemedicine for low-risk pregnant women and improve the delivery of prenatal care. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Remote Prenatal Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Nov 2016
- 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A pregnant woman initiating prenatal care between 6 0/7 weeks and 16 0/7 weeks estimated gestational age (EGA) by reliable last menstrual period (LMP) or ultrasound. All participants must have confirmation of pregnancy viability (by Doppler or ultrasound) prior to study enrollment. All participants must, by 24 weeks gestation, have ultrasonographic confirmation of a single viable intrauterine pregnancy with no major anomalies.
- All participants must have had at least one prior term, uncomplicated delivery. This will be ascertained at time of enrollment by care provider.
- Must be willing and able to perform remote monitoring study requirements at home. This includes having a computer with internet access at home (preferred but not required); must have already registered or be willing to register for Epic MyChart; be willing and capable (after instruction) of using at-home monitoring devices including fetal health monitor, automatic blood pressure monitor, and weight scale; be willing and capable (after instruction) of entering information from at-home monitoring devices into Epic MyChart; be willing and capable (after instruction) of using a web-based video conferencing solution or telephone for communication with clinician.
- Intention to deliver at the University Hospital.
- The patient is seeing a participating provider at a participating clinic.
Who cannot join
- Participant age at enrollment is younger than 20 or older than 39 years of age at the time of delivery.
- Not fluent in English
- Absence of prior term deliveries.
- Significant complications in any previous viable pregnancy include two or more previous miscarriages, preterm birth(<37 0/7 weeks), preeclampsia, placental abruption, stillbirth, etc.
- Any significant concurrent medical problems such as cardiovascular disease, diabetes, hypertension, prior venous thromboembolism, autoimmune disease (exception: women with well-controlled hypothyroidism may enroll), and any other medical problem of concerned as deemed by her prenatal care provider.
- Use of known risk factors such as smoking, alcohol, illegal drug use, or other known teratogenic exposures.
- Multifetal pregnancy or known fetal anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
About this study
Official title: Personalized Prenatal Care for Low-Risk Pregnancies Using Remote Patient Monitoring
Not all pregnant women have the same risks for pregnancy complications. Women at low-risk for pregnancy complications may not need the same type of prenatal care. The goal of this study is to learn about the use of telemedicine for low-risk pregnant women and improve the delivery of prenatal care. Telemedicine is medical care provided using a computer or telephone to visit with a doctor for some medical appointments. Participating patients will be assigned by a computer to either standard prenatal care, or prenatal care involving a combination of standard prenatal visits and telemedicine visits. Both groups will have the same number of prenatal care visits.
In both groups, we will ask about the patients' satisfaction with their care, the amount of time they spent visiting with their doctor, and information about time and their expenses. In the telemedicine group, we will teach how to measure blood pressure, fetal heart rate, and weight from home.
The goals of this study are to: 1) assess the patient satisfaction, patient experiences and preferences, financial impact, clinical outcomes, and provider satisfaction of providing personalized prenatal care for low-risk pregnancies using telecommunication and remote patient care devices; and 2) measure the reliability of at-home, patient-recorded, computer-documented prenatal care measurements. The primary outcome is patient satisfaction with prenatal care after delivery.
Read the detailed description
Study procedures and data collection for a woman enrolled to the study are described below:
- Randomization Prior to enrollment in the study, eligible participating patients will be randomized into the control or remote prenatal care groups. The study coordinator will be aware of which group the participant is assigned to and provide training tailored to the assigned study group. The telemedicine group will receive all training described below. The control group will only receive training on the survey instrument and instruction on how to access the message box within MyChart.
- Remote Monitoring Devices Remote prenatal care group participants will measure, record, and submit their blood pressure, weight, and fetal heart recordings into MyChart (described below) no more than 48 hours prior to a scheduled remote prenatal care visit (described below).
- Weight- Participants will use their home scale or be given one to use if they don't have one. For demonstration purposes, a scale will be available during the in-person visit with the study coordinator. The patient is required to measure weight in pounds to the nearest pound.
- Blood Pressure- Participants will be provided one digital blood pressure cuff that will measure their blood pressure to be used throughout the pregnancy. They will be required to report the systolic and diastolic blood pressure as measured and displayed by the device in millimetres of mercury (mmHg).
- Fetal Heart Rate- Participants will be provided one digital fetal doppler monitor to be used throughout the pregnancy. They will use it to determine the fetus' heart rate in beats per minute. Patients will be allowed to keep the devices at the conclusion of the study as compensation for participating and completing the research.
- MyChart Epic MyChart is the personal health record that is linked to the Epic electronic health record used by the University of Utah. Participants will use MyChart to record information to allow their recordings to integrate within the Epic electronic health record and be viewable by the treating clinician. At each time point that requires patient recording of health data described above, patient-entered flowsheets will be available with the required data fields. Help text will also be available on the form to assist proper data entry. Automated data validity checking will assure data are properly recorded.
- Remote Prenatal Care Visit The remote prenatal care visit will be conducted at a predetermined scheduled time using a web-based, Health Insurance Portability and Accountability Act (HIPAA-compliant video communication solution provided by the University of Utah Department of Telemedicine. A message will be sent to the participant within MyChart containing the video link and password prior to the meeting. If the video solution does not work, is having difficulties, or if the patient does not prefer using video, the prenatal care visit will be conducted by telephone.
- Survey Instrument The survey instrument, built using REDCap, will be available immediately following a scheduled visit. A link to the survey will be available in MyChart as well as emailed to their message box within MyChart. If the survey hasn't been completed within 72 hours, the study coordinator will contact the participant to remind them to complete the survey. Participants will have one week to complete the survey.
- Sample Size/Statistical Analysis Plan Sample size is based on non-inferiority test. We assume that in the control group that 80% will be satisfied. We are allowing for a relative 10% worse-than non-inferiority margin, which equates to the intervention group can have a satisfaction percent of 72%.
A sample size of 100 per group using 80% power and a two-sided 0.05 alpha comparison allows for the intervention group to have satisfaction of 85%. It is reasonable to expect this given the perceived advantage of not having to travel.
We will test for superiority only after having demonstrated non-inferiority. In this step-wise method, multiple comparisons adjustment is not needed.
- Conditions
- Pregnancy
- Being tested
- Remote Prenatal Care
- Keywords
- Prenatal care, Pregnancy, Obstetrics, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Prenatal CareOther
Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.
| Study group | Role | What they receive |
|---|---|---|
| Remote Prenatal Care | Experimental | Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits. Receives: Other: Remote Prenatal Care |
| Usual Prenatal Care | No intervention | Usual, in-person prenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with remote prenatal care
Assessment of patient satisfaction, experiences and preferences regarding personalized prenatal care using telecommunication and remote patient care devices.
Measured: 24 months
Secondary outcomes (3)
Cost-effectiveness
Assessment of financial impact for individuals and the health care system of personalized prenatal care for low-risk pregnancies using telecommunication and remote patient care devices.
Measured: 24 months
Provider satisfaction
Assessment of health care provider satisfaction with personalized prenatal care for low-risk pregnancies using telecommunication and remote patient care devices.
Measured: 24 months
Perinatal outcomes
Assessment of maternal and neonatal outcomes in remote prenatal care compared to routine prenatal care.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Clark, University of Utah
- Investigators
- Erin A. S. Clark, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970436
- Sponsor's protocol ID
- 64042
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Prenatal Care for Low-Risk Pregnancies Using Remote Patient Monitoring
- ClinicalTrials.gov ID
- NCT01970436
- Acronym / sponsor ID
- 64042
- Conditions
- Pregnancy
- Keywords
- Prenatal care, Pregnancy, Obstetrics, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Oct 2013 (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.
Not all pregnant women have the same risks for pregnancy complications. Women at low-risk for pregnancy complications may not need the same type of prenatal care. The goal of this study is to learn about the use of telemedicine for low-risk pregnant women and improve the delivery of prenatal care. Telemedicine is medical care provided using a computer or telephone to visit with a doctor for some medical appointments. Participating patients will be assigned by a computer to either standard prenatal care, or prenatal care involving a combination of standard prenatal visits and telemedicine visits. Both groups will have the same number of prenatal care visits.
In both groups, we will ask about the patients' satisfaction with their care, the amount of time they spent visiting with their doctor, and information about time and their expenses. In the telemedicine group, we will teach how to measure blood pressure, fetal heart rate, and weight from home.
The goals of this study are to: 1) assess the patient satisfaction, patient experiences and preferences, financial impact, clinical outcomes, and provider satisfaction of providing personalized prenatal care for low-risk pregnancies using telecommunication and remote patient care devices; and 2) measure the reliability of at-home, patient-recorded, computer-documented prenatal care measurements. The primary outcome is patient satisfaction with prenatal care after delivery.
Detailed description
Study procedures and data collection for a woman enrolled to the study are described below:
- Randomization Prior to enrollment in the study, eligible participating patients will be randomized into the control or remote prenatal care groups. The study coordinator will be aware of which group the participant is assigned to and provide training tailored to the assigned study group. The telemedicine group will receive all training described below. The control group will only receive training on the survey instrument and instruction on how to access the message box within MyChart.
- Remote Monitoring Devices Remote prenatal care group participants will measure, record, and submit their blood pressure, weight, and fetal heart recordings into MyChart (described below) no more than 48 hours prior to a scheduled remote prenatal care visit (described below).
- Weight- Participants will use their home scale or be given one to use if they don't have one. For demonstration purposes, a scale will be available during the in-person visit with the study coordinator. The patient is required to measure weight in pounds to the nearest pound.
- Blood Pressure- Participants will be provided one digital blood pressure cuff that will measure their blood pressure to be used throughout the pregnancy. They will be required to report the systolic and diastolic blood pressure as measured and displayed by the device in millimetres of mercury (mmHg).
- Fetal Heart Rate- Participants will be provided one digital fetal doppler monitor to be used throughout the pregnancy. They will use it to determine the fetus' heart rate in beats per minute. Patients will be allowed to keep the devices at the conclusion of the study as compensation for participating and completing the research.
- MyChart Epic MyChart is the personal health record that is linked to the Epic electronic health record used by the University of Utah. Participants will use MyChart to record information to allow their recordings to integrate within the Epic electronic health record and be viewable by the treating clinician. At each time point that requires patient recording of health data described above, patient-entered flowsheets will be available with the required data fields. Help text will also be available on the form to assist proper data entry. Automated data validity checking will assure data are properly recorded.
- Remote Prenatal Care Visit The remote prenatal care visit will be conducted at a predetermined scheduled time using a web-based, Health Insurance Portability and Accountability Act (HIPAA-compliant video communication solution provided by the University of Utah Department of Telemedicine. A message will be sent to the participant within MyChart containing the video link and password prior to the meeting. If the video solution does not work, is having difficulties, or if the patient does not prefer using video, the prenatal care visit will be conducted by telephone.
- Survey Instrument The survey instrument, built using REDCap, will be available immediately following a scheduled visit. A link to the survey will be available in MyChart as well as emailed to their message box within MyChart. If the survey hasn't been completed within 72 hours, the study coordinator will contact the participant to remind them to complete the survey. Participants will have one week to complete the survey.
- Sample Size/Statistical Analysis Plan Sample size is based on non-inferiority test. We assume that in the control group that 80% will be satisfied. We are allowing for a relative 10% worse-than non-inferiority margin, which equates to the intervention group can have a satisfaction percent of 72%.
A sample size of 100 per group using 80% power and a two-sided 0.05 alpha comparison allows for the intervention group to have satisfaction of 85%. It is reasonable to expect this given the perceived advantage of not having to travel.
We will test for superiority only after having demonstrated non-inferiority. In this step-wise method, multiple comparisons adjustment is not needed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Prenatal Care | Experimental | Other: Remote Prenatal CareRemote Prenatal Care using a combination of in-person and telemedicine prenatal care visits. |
| Usual Prenatal Care | No intervention | –Usual, in-person prenatal care. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A pregnant woman initiating prenatal care between 6 0/7 weeks and 16 0/7 weeks estimated gestational age (EGA) by reliable last menstrual period (LMP) or ultrasound. All participants must have confirmation of pregnancy viability (by Doppler or ultrasound) prior to study enrollment. All participants must, by 24 weeks gestation, have ultrasonographic confirmation of a single viable intrauterine pregnancy with no major anomalies.
- All participants must have had at least one prior term, uncomplicated delivery. This will be ascertained at time of enrollment by care provider.
- Must be willing and able to perform remote monitoring study requirements at home. This includes having a computer with internet access at home (preferred but not required); must have already registered or be willing to register for Epic MyChart; be willing and capable (after instruction) of using at-home monitoring devices including fetal health monitor, automatic blood pressure monitor, and weight scale; be willing and capable (after instruction) of entering information from at-home monitoring devices into Epic MyChart; be willing and capable (after instruction) of using a web-based video conferencing solution or telephone for communication with clinician.
- Intention to deliver at the University Hospital.
- The patient is seeing a participating provider at a participating clinic.
Key exclusion criteria (7 listed)
- Participant age at enrollment is younger than 20 or older than 39 years of age at the time of delivery.
- Not fluent in English
- Absence of prior term deliveries.
- Significant complications in any previous viable pregnancy include two or more previous miscarriages, preterm birth(<37 0/7 weeks), preeclampsia, placental abruption, stillbirth, etc.
- Any significant concurrent medical problems such as cardiovascular disease, diabetes, hypertension, prior venous thromboembolism, autoimmune disease (exception: women with well-controlled hypothyroidism may enroll), and any other medical problem of concerned as deemed by her prenatal care provider.
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 |
|---|---|---|
| Remote Prenatal CareRemote Prenatal Care using a combination of in-person and telemedicine prenatal care visits. | Other | Remote Prenatal Care |
Primary outcome
Patient satisfaction with remote prenatal care
Time frame: 24 months
Assessment of patient satisfaction, experiences and preferences regarding personalized prenatal care using telecommunication and remote patient care devices.
3 secondary outcomes
Cost-effectiveness
Time frame: 24 months
Provider satisfaction
Time frame: 24 months
Perinatal outcomes
Time frame: 24 months
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 6 Nov 2017.
- 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.
Erin A. S. Clark, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Prenatal Care in people with Pregnancy, run by University of Utah at 1 site in United States.
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 5 inclusion and 7 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 6 Nov 2017. 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 United States. 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?
Patient satisfaction with remote prenatal care (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2017.