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Prematurity Education in High Risk Pregnancies

University Hospitals (UH) logo

University Hospitals (UH)

Status

Completed

Conditions

Prematurity
High Risk Pregnancy

Treatments

Other: Early counseling of prematurity in high-risk pregnancies.

Study type

Interventional

Funder types

Other

Identifiers

NCT03772080
STUDY20180789

Details and patient eligibility

About

Prematurity is associated with significant morbidity and mortality. Given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child. Unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult. This study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.

Enrollment

76 patients

Sex

Female

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery.

    1. Premature delivery defined as <37 0/7 weeks gestation.
    2. Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at high risk for premature delivery.
  2. Pregnant women 16 years and older.

  3. Pregnancy with singleton or twin gestation.

  4. No major congenital malformation.

  5. Women who are English speaking.

Exclusion criteria

  1. Pregnant women <22 0/7 or >35 0/7 weeks gestational age.
  2. Pregnant women less than 16 years old.
  3. Multiple gestation greater than twins (triplets, quadruplets, etc).
  4. Known major congenital malformation.
  5. Women who are non-English speaking.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 2 patient groups

Early counseling of prematurity in high-risk pregnancies
Experimental group
Treatment:
Other: Early counseling of prematurity in high-risk pregnancies.
Standard counseling of prematurity in high-risk pregnancies
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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