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

NCT02707237 | Completed

• 1 other identifier: IRB 15-226
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy Preterm; Counseling

Outcome Measures

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

  one year

Secondary Outcomes (1)

• Maternal anxiety level

  one year

Study Arms (2)

Verbal counseling

OTHER

Parents with threatened delivery will receive verbal counseling only

Other: Verbal counseling

Verbal, pictorial, written counseling

OTHER

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

Other: Verbal, pictorial, written counseling

Interventions

Verbal counseling OTHER

Verbal counseling done by physician

Verbal counseling

Verbal, pictorial, written counseling OTHER

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

Verbal, pictorial, written counseling

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cook County Health: lead

Study Sites (1)

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• 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.

  PMID: 19117868 BACKGROUND

• 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.

  PMID: 23079775 BACKGROUND

• 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.

  PMID: 15805351 BACKGROUND

• 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.

  PMID: 22492766 BACKGROUND

• Budhani S, Akintorin M, Soyemi K, Fogg L, Arlandson M, Kumar R. Maternal counseling for preterm deliveries, assessing an effective method of counseling: A randomized trial. PLoS One. 2025 Apr 9;20(4):e0294168. doi: 10.1371/journal.pone.0294168. eCollection 2025.

  PMID: 40203068 DERIVED

Study Officials

• Mopelola Akintorin, MD

  Cook County Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: March 14, 2016
• Study Start: March 1, 2016
• Primary Completion: October 22, 2017
• Study Completion: October 22, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)