Evaluation of a Decision Aid for Early Pregnancy Loss

NCT04410029 | Completed

• 1 other identifier: 842526
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effect of the Healthwise decision aid on shared decision making in women undergoing management of early pregnancy loss.

Conditions

Early Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Decision Conflict Scale (DCS)

  Low-literacy version of Decision Conflict Scale

  Post-counseling (one day)

Study Arms (2)

Intervention

EXPERIMENTAL

Standard counseling + Healthwise Decision Aid

Other: Healthwise Decision Aid

Control

ACTIVE COMPARATOR

Standard counseling + a control informational handout.

Other: Control informational handout

Interventions

Healthwise Decision Aid OTHER

Healthwise, a non-profit company that develops health content and patient information for hospitals, has created a decision aid for EPL management that is available through the EPIC Systems, an electronic medical record. Participants will be given this decision aid after EPL diagnosis and prior to options consultation with a provider.

Intervention

Control informational handout OTHER

Participants randomized to the control arm will be given an informational handout of treatment options after EPL diagnosis and prior to options consultation with a provider.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Definitive diagnosis of early intrauterine pregnancy loss (including anembryonic pregnancy and missed abortion \[ultrasound examination demonstrates fetal pole without cardiac activity measuring between 5.3 and 7mm or an abnormal growth pattern diagnostic of EPL\])
• years or older
• Willing and able to give informed consent

You may not qualify if:

• Pregnancy of unknown anatomic location
• Unable to read English
• Prior options counseling with a Family Planning provider
• Clinically unstable requiring emergent surgical management with uterine evacuation.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Society of Family Planning: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19143, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 1, 2020
• Study Start: July 29, 2020
• Primary Completion: March 23, 2021
• Study Completion: March 25, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)