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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02707237
Enrollment
92
Registered
2016-03-14
Start date
2016-03-31
Completion date
2017-10-22
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Counseling, Pregnancy Preterm

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

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

Interventions

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

Sponsors

Cook County Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient knowledgeone yearAfter 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

Secondary

MeasureTime frameDescription
Maternal anxiety levelone yearPre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026