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CompletedNCT02707237Updated Nov 6, 2017

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

An interventional study of Verbal counseling and Verbal, pictorial, written counseling in Pregnancy Preterm and Counseling, sponsored by Cook County Health. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Cook County Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Sex
Female
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Study 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

Read the 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

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Conditions studied

  • Pregnancy Preterm
  • Counseling

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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 92 is close to the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Cook County Health is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
92 participants (actual)

Study arms

  • Other
    Verbal counseling

    Parents with threatened delivery will receive verbal counseling only

    Other: Verbal counseling

  • Other
    Verbal, pictorial, written counseling

    Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information

    Other: Verbal, pictorial, written counseling

Interventions

  • OtherVerbal counseling

    Verbal counseling done by physician

  • OtherVerbal, pictorial, written counseling

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: one year

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Study locations

1 site
  • John H Stroger Jr Hospital of Cook County
    Chicago, Illinois 60612, United States
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References and documents

Publications

  • 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. PubMed 19117868 ↗
  • 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. PubMed 23079775 ↗
  • 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. PubMed 15805351 ↗
  • 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. PubMed 22492766 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02707237
Lead sponsor
Cook County Health
Responsible party
Mopelola Akintorin (MD, Cook County Health) — Principal investigator
First posted
Mar 14, 2016
Start date
Mar 2016
Primary completion
Oct 22, 2017
Completion
Oct 22, 2017
Last update
Nov 6, 2017

Study contacts

Mopelola Akintorin, MD
principal investigator · Cook County Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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