NCT01119183

Brief Summary

Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

April 23, 2010

Last Update Submit

June 9, 2022

Conditions

Preeclampsia

Keywords

Patient understanding and counseling

Outcome Measures

Primary Outcomes (1)

  • Improved understanding of preeclampsia

    Understanding of preeclampsia will be assessed through a questionnaire that asks a series of closed ended questions about preeclampsia as well as a single open ended question. This questionnaire has been used in a prior study and has proven to be a useful assessment of patient knowledge.

    one week

Study Arms (3)

1

NO INTERVENTION

2

ACTIVE COMPARATOR
Behavioral: ACOG education pamphlet on preeclampsia

3

EXPERIMENTAL
Behavioral: Preeclampsia education tool

Interventions

ACOG education pamphlet on preeclampsiaBEHAVIORAL

The ACOG pamphlet on preeclampsia will be offered to this group

2
Preeclampsia education toolBEHAVIORAL

The newly created preeclampsia educational tool will be offered to this group

3

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • weeks pregnant
  • No significant hearing or vision impairment
  • English speaking

You may not qualify if:

  • Active diagnosis of preeclampsia
  • Significant hearing or vision impairment
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.

    PMID: 22542120DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital 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

Study Record Dates

First Submitted

April 23, 2010

First Posted

May 7, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 13, 2022

Record last verified: 2022-06

Locations

US(1)