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

NCT ID: NCT02707237

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-10-22

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Verbal counseling

Parents with threatened delivery will receive verbal counseling only

Group Type OTHER

Verbal counseling

Intervention Type OTHER

Verbal counseling done by physician

Verbal, pictorial, written counseling

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

Group Type OTHER

Verbal, pictorial, written counseling

Intervention Type OTHER

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

Interventions

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Verbal counseling

Verbal counseling done by physician

Intervention Type OTHER

Verbal, pictorial, written counseling

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

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cook County Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mopelola Akintorin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mopelola Akintorin, MD

Role: PRINCIPAL_INVESTIGATOR

Cook County Health

Locations

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John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19117868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23079775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15805351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22492766 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40203068 (View on PubMed)

Other Identifiers

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IRB 15-226

Identifier Type: -

Identifier Source: org_study_id