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Completed

NCT Number: NCT02707237

Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling

Providing verbal counseling supplemented with both written and pictorial information then verbal counseling alone is a more effective method of counseling parents with threatened preterm delivery

Completed

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Key information

Conditions

Pregnancy Preterm Counseling

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

About this study

Progress in the frontiers of neonatology has continually pushed back the limit of viability and significantly improved the survival of extremely preterm infants. An important component of medical management before a preterm delivery is counseling the parents about probabilities of survival and long term complications.

Hypothesis: Preterm counseling is more effective when parents receive verbal counseling supplemented with written and pictorial information then verbal counseling alone.

Methodology: There will be two groups of study (verbal, pictorial and written vs verbal alone). All patients admitted to the L and D department of Stroger hospital between 23 to 34 weeks of gestation with threatened premature delivery will be enrolled in the study. They will be randomly assigned to 1 of 2 groups. After counseling, parents will be asked to complete a 32 point questionnaire to check their knowledge of outcomes of prematurity.

To reach statistically significant results, the investigators will need 40 patients in each group. The study will be done over a period of one year

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women between 23 to 34 weeks gestation assessed by obstetrician to need counseling

Exclusion criteria

  • Pregnancies with known life threatening defects considered as non compatible with life.
  • Mothers previously admitted and counseled will also be excluded

Treatment and study plan

Verbal counseling

Other

Verbal counseling done by physician

Verbal, pictorial, written counseling

Other

verbal counseling in addition to gestational age specific written information and pictures will be given to parents

Primary outcomes

  1. Patient knowledge

    Time frame: one year

    After counseling, patient will answer a 32 point questionnaire and this will be compared across the two groups to see there is any statistical difference between the two groups using SPSS

Secondary outcomes

  1. Maternal anxiety level

    Time frame: one year

    Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance

Sponsors and collaborators

Lead sponsor

Cook County Health

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2016
Registry last updated
Nov 6, 2017

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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