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

Study Overview
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Brief Summary
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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
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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

Conditions
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Pregnancy Preterm, Counseling

Intervention / Treatment
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* Other: Verbal counseling
* Other: Verbal, pictorial, written counseling


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Verbal counseling<br>Parents with threatened delivery will receive verbal counseling only | Other: Verbal counseling<br>* Verbal counseling done by physician<br>|
| Other: Verbal, pictorial, written counseling<br>Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information | Other: Verbal, pictorial, written counseling<br>* verbal counseling in addition to gestational age specific written information and pictures will be given to parents<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient knowledge | 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal anxiety level | Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance | one year |