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Completed

NCT Number: NCT01418950

Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Written information and verbal counseling

Other

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

Primary outcomes

  1. Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.

    Time frame: Within 24 hours of counseling the primary outcome will be assessed

    The knowledge questionnaire consists of questions regarding gestational age specific common potential problems and complications of premature infants. We will score each questionniare and then compare number of correct answers.

Secondary outcomes

  1. The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups

    Time frame: The pre-counseling anxiety score will be obtained immediately after consent is obtained for the study. The post-counseling anxiety score will be obtained within 24 hours of counseling

    State Trait anxiety Inventory has been used in many studies

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2011
Registry last updated
Dec 18, 2013

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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