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An Electronic Medical Record Alert of Progesterone

NCT03219489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-03-25

No results posted yet for this study

Summary

Progesterone can be given to women at risk for preterm birth, and is advocated by many guidelines as progesterone has been shown to markedly decrease preterm birth, death in newborns, and disability. However, not all eligible women are currently receiving this medication. Thus, there is an urgent need to improve prevention of preterm birth with progesterone. In response to the low number of women receiving this medication, the investigators have designed a potential method to increase progesterone use.

This method involves the use of an "alert" programmed into electronic medical records, to prompt doctors to prescribe progesterone to women at risk of preterm birth. This study is a randomized controlled trial that will assess the feasibility of using this "alert", by randomly assigning 8 clinics to either use this alert, or to provide their usual prenatal care. The investigators will then study whether the alert improved prescription of progesterone, and examine neonatal outcomes such as preterm birth and birth weight. Care providers will be asked for their feedback and thoughts about the alert, through questionnaires and structured interviews.

The investigators hypothesize that the electronic medical record alert will increase care provider recommendations and prescription of progesterone for women at risk of preterm birth. The investigators hope that this study will lay the groundwork for larger future studies aimed to strengthen health care quality and improve the health outcomes of women and their babies.

Conditions

Interventions

OTHER

Electronic medical record alert

An electronic medical record alert will be inserted into the clinic's electronic medical records. The alert reads: "Consider Progesterone 100-200 mg pv qhs \> or =16 weeks, if previous spontaneous PTB or current short cervix, and no allergies to peanuts or progesterone." This alert will appear on the Ministry of Health-mandated Perinatal Records.

Sponsors & Collaborators

Principal Investigators

  • Sarah D McDonald, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2018-12-03
Completion
2018-12-03

Countries

  • Canada

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03219489 on ClinicalTrials.gov