Personalized Prenatal Care for Low-Risk Pregnancies Using Telemedicine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Erin Clark, University of Utah
ClinicalTrials.gov Identifier:
NCT01970436
First received: October 22, 2013
Last updated: August 10, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Pregnancy
Other: Remote Prenatal Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Personalized Prenatal Care for Low-Risk Pregnancies Using Remote Patient Monitoring

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Patient satisfaction with remote prenatal care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessment of patient satisfaction, experiences and preferences regarding personalized prenatal care using telecommunication and remote patient care devices.


Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Provider satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessment of health care provider satisfaction with personalized prenatal care for low-risk pregnancies using telecommunication and remote patient care devices.

  • Perinatal outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessment of maternal and neonatal outcomes in remote prenatal care compared to routine prenatal care.


Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: August 2017
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote Prenatal Care
Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.
Other: Remote Prenatal Care
Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.
No Intervention: Usual Prenatal Care
Usual, in-person prenatal care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970436

Locations
United States, Utah
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Erin A. S. Clark, MD University of Utah
  More Information

Additional Information:
Responsible Party: Erin Clark, Assistant Professor Maternal Fetal Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT01970436     History of Changes
Other Study ID Numbers: 64042 
Study First Received: October 22, 2013
Last Updated: August 10, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Utah:
Prenatal care
Pregnancy
Obstetrics
Telemedicine

ClinicalTrials.gov processed this record on August 30, 2016