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

Pregnancy Preterm Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707237
• Other study ID #: IRB 15-226
• Status: Completed
• Phase: N/A
• First received: February 8, 2016
• Last updated: November 1, 2017
• Start date: March 2016
• Est. completion date: October 22, 2017

Study information

• Verified date: November 2017
• Source: John H. Stroger Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 22, 2017
• Est. primary completion date: October 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Counseling
• Pregnancy Preterm
• Premature Birth

Intervention

Other:
• Verbal counseling
Verbal counseling done by physician
• Verbal, pictorial, written counseling
verbal counseling in addition to gestational age specific written information and pictures will be given to parents

Locations

Country	Name	City	State
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
John H. Stroger Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Blanco F, Suresh G, Howard D, Soll RF. Ensuring accurate knowledge of prematurity outcomes for prenatal counseling. Pediatrics. 2005 Apr;115(4):e478-87. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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