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Completed

NCT Number: NCT02914301

Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study

Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

About this study

This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on:

  • the number of in-person OB visits during pregnancy;
  • patient satisfaction with prenatal care;
  • gestational weight gain;
  • maternal and fetal outcomes; and
  • clinician satisfaction.

To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible participants will be women who are between 18 than 40-years-old, who are visiting the OB for a first-trimester verification of pregnancy visit, new OB visit or follow-up OB visit, who are low-risk per treating OB, who regularly use a smart-phone, who can understand and consent to English-written consent form.
  • Eligible clinicians will be attending obstetric physicians who refer the patient to the research assistant for informed consent and full eligibility assessment.

Exclusion criteria

  • High-risk obstetrical condition*
  • Intends midwifery care
  • Intends to terminate
  • Not Local resident
  • Non--English speaker

Treatment and study plan

Babyscripts Prenatal App

Device

The use of a mobile digital app to facilitate certain aspects of standard prenatal care.

PLACEBO

Device

No Mobile App, Usual care

Primary outcomes

  1. Total Visit Number

    Time frame: From first trimester up to postpartum, between 6 and 9 months

    In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.

Secondary outcomes

  1. Gestational Weight Gain

    Time frame: From first trimester up to postpartum, between 6 and 9 months

    We will assess gestational weight gain following enrollment until delivery. These measures will be obtained by health record review and review of data collected in the app. Data collection will be performed with a standardized data collection sheet and a 10% check for interrater reliability.

Sponsors and collaborators

Lead sponsor

Andrew Meltzer

Other

Collaborators

  • 1EQ, Inc.

Registry information

Official study title

Effectiveness of a Mobile App for Prenatal Care to Safely Reduce In-Person Visits and Improve Patient Satisfaction: Study Protocol for a Multicenter Prospective Quasi-Randomized Trial

Acronym: SPROUT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2016
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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