- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707237
Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- John H Stroger Jr Hospital of Cook County
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Verbal counseling
Parents with threatened delivery will receive verbal counseling only
|
Verbal counseling done by physician
|
Other: Verbal, pictorial, written counseling
Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information
|
verbal counseling in addition to gestational age specific written information and pictures will be given to parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient knowledge
Time Frame: one year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal anxiety level
Time Frame: one year
|
Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mopelola Akintorin, MD, John H. Stroger Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 15-226
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy Preterm
-
Konya Meram State HospitalRecruitingPregnancy Preterm | Preterm Labor Without DeliveryTurkey
-
PreTeL, IncDuke University; University of RochesterRecruitingPreterm Birth | Threatened Preterm Labor | PreTerm LaborUnited States
-
Istanbul University - Cerrahpasa (IUC)CompletedPreterm Labor | Preterm Spontaneous Labor With Preterm Delivery | Preterm Labor With Preterm Delivery in Third TrimesterTurkey
-
Ain Shams UniversityRecruitingPreterm Labor With Preterm DeliveryEgypt
-
University Hospital, Strasbourg, FranceRecruitingPreterm Delivery | Threatened Preterm LaborFrance
-
Eunice Kennedy Shriver National Institute of Child...CompletedPregnancy | Preterm Birth | Preterm LaborUnited States
-
University of Modena and Reggio EmiliaNot yet recruitingPreterm Labor With Preterm DeliveryItaly
-
PreTeL, IncUniversity of RochesterCompletedPreterm Labor | Pregnancy Preterm | Labor; IrregularUnited States
-
e-Bio CorpRecruitingPreterm Labor | PreTerm Birth | Preterm Labor With Delivery NosUnited States
-
Eunice Kennedy Shriver National Institute of Child...CompletedPremature Birth | Pregnancy | Preterm Birth | Preterm Delivery | Prenatal CareUnited States
Clinical Trials on Verbal counseling
-
Medical College of WisconsinCompletedPremature BirthUnited States
-
Istanbul UniversityCompleted
-
University of Missouri, Kansas CityCompleted
-
Federal University of São PauloUnknownLower Urinary Tract Symptoms | Urinary Incontinence | Urination Disorders | Urinary Incontinence, StressBrazil
-
Emory UniversityCompleted
-
Mid Western Regional Hospital, IrelandCompleted
-
Memorial Sloan Kettering Cancer CenterCompleted
-
Advocate Health CareCompletedDown SyndromeUnited States
-
Parc de Salut MarCompletedTotal Knee ReplacementSpain
-
Clinica Alemana de SantiagoUnknownPreterm Infant | Social Withdrawal of Childhood or AdolescenceChile