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Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

NCT ID: NCT01418950

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-03-31

Brief Summary

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Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.

Detailed Description

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Conditions

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Premature Birth

Keywords

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Prematurity Counseling for pregnant women and their family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

The control group will receive standard verbal counseling regarding outcome of premature infants

Group Type ACTIVE_COMPARATOR

Written information and verbal counseling

Intervention Type OTHER

control group will only receive verbal counseling. Study group will receive written information before verbal counseling

Study Group

Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants.

Group Type EXPERIMENTAL

Written information and verbal counseling

Intervention Type OTHER

control group will only receive verbal counseling. Study group will receive written information before verbal counseling

Interventions

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Written information and verbal counseling

control group will only receive verbal counseling. Study group will receive written information before verbal counseling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* English speaking pregnant women who are between 23-34 weeks of gestation
* Who are 18 years and older
* Open to all ethnic groups.
* Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.

Exclusion Criteria

* Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.
* Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.
* If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mir Basir, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.

Reference Type DERIVED
PMID: 22492766 (View on PubMed)

Other Identifiers

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PRO00010267

Identifier Type: -

Identifier Source: org_study_id