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

C

Cook County Health

Status

Completed

Conditions

Counseling
Pregnancy Preterm

Treatments

Other: Verbal counseling
Other: Verbal, pictorial, written counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02707237
IRB 15-226

Details and patient eligibility

About

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

Full 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

Enrollment

92 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

92 participants in 2 patient groups

Verbal counseling
Other group
Description:
Parents with threatened delivery will receive verbal counseling only
Treatment:
Other: Verbal counseling
Verbal, pictorial, written counseling
Other group
Description:
Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information
Treatment:
Other: Verbal, pictorial, written counseling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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