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

Not Applicable

Completed

• Conditions: Counseling; Pregnancy Preterm

• Registration Number: NCT02707237
• Lead Sponsor: Cook County Health

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-02-08
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Primary Completion: 2017-10-22
• Study Completion: 2017-10-22
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-01
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Patient knowledge	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 Outcome Measures

Name	Time	Method
Maternal anxiety level	one year	Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance

Trial Locations

Locations (1)

John H Stroger Jr Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States