Personalized Prenatal Care for Low-Risk Pregnancies Using Telemedicine

NCT01970436 | Completed

• 1 other identifier: 64042
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pregnancy

Keywords

Prenatal care; Pregnancy; Obstetrics; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction with remote prenatal care

  Assessment of patient satisfaction, experiences and preferences regarding personalized prenatal care using telecommunication and remote patient care devices.

  24 months

Secondary Outcomes (3)

• Cost-effectiveness

  24 months

• Provider satisfaction

  24 months

• Perinatal outcomes

  24 months

Study Arms (2)

Remote Prenatal Care

EXPERIMENTAL

Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.

Other: Remote Prenatal Care

Usual Prenatal Care

NO INTERVENTION

Usual, in-person prenatal care.

Interventions

Remote Prenatal Care OTHER

Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.

Remote Prenatal Care

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Study Officials

• Erin A. S. Clark, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Maternal Fetal Medicine

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 28, 2013
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)