Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
Primary Purpose
Pregnancy Preterm, Counseling
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verbal counseling
Verbal, pictorial, written counseling
Sponsored by

About this trial
This is an interventional supportive care trial for Pregnancy Preterm
Eligibility Criteria
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
Sites / Locations
- John H Stroger Jr Hospital of Cook County
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Verbal counseling
Verbal, pictorial, written counseling
Arm Description
Parents with threatened delivery will receive verbal counseling only
Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02707237
Brief Title
Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 22, 2017 (Actual)
Study Completion Date
October 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Preterm, Counseling
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verbal counseling
Arm Type
Other
Arm Description
Parents with threatened delivery will receive verbal counseling only
Arm Title
Verbal, pictorial, written counseling
Arm Type
Other
Arm Description
Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information
Intervention Type
Other
Intervention Name(s)
Verbal counseling
Intervention Description
Verbal counseling done by physician
Intervention Type
Other
Intervention Name(s)
Verbal, pictorial, written counseling
Intervention Description
verbal counseling in addition to gestational age specific written information and pictures will be given to parents
Primary Outcome Measure Information:
Title
Patient knowledge
Description
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
Time Frame
one year
Secondary Outcome Measure Information:
Title
Maternal anxiety level
Description
Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance
Time Frame
one year
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mopelola Akintorin, MD
Organizational Affiliation
Cook County Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19117868
Citation
Khashu M, Narayanan M, Bhargava S, Osiovich H. Perinatal outcomes associated with preterm birth at 33 to 36 weeks' gestation: a population-based cohort study. Pediatrics. 2009 Jan;123(1):109-13. doi: 10.1542/peds.2007-3743.
Results Reference
background
PubMed Identifier
23079775
Citation
Govande VP, Brasel KJ, Das UG, Koop JI, Lagatta J, Basir MA. Prenatal counseling beyond the threshold of viability. J Perinatol. 2013 May;33(5):358-62. doi: 10.1038/jp.2012.129. Epub 2012 Oct 18.
Results Reference
background
PubMed Identifier
15805351
Citation
Blanco F, Suresh G, Howard D, Soll RF. Ensuring accurate knowledge of prematurity outcomes for prenatal counseling. Pediatrics. 2005 Apr;115(4):e478-87. doi: 10.1542/peds.2004-1417.
Results Reference
background
PubMed Identifier
22492766
Citation
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.
Results Reference
background
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Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
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