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Completed

NCT Number: NCT03772080

Prematurity Education in High Risk Pregnancies

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications High Risk Pregnancy Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery.
  • Premature delivery defined as <37 0/7 weeks gestation.
  • Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at high risk for premature delivery.
  • Pregnant women 16 years and older.
  • Pregnancy with singleton or twin gestation.
  • No major congenital malformation.
  • Women who are English speaking.

Exclusion criteria

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

Treatment and study plan

Early counseling of prematurity in high-risk pregnancies.

Other

Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.

Primary outcomes

  1. Parental knowledge of prematurity.

    Time frame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.

    Questionnaire to assess parental knowledge regarding basic concepts of prematurity, associated complications and factors that improve survival.

  2. Parental satisfaction with prematurity education.

    Time frame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.

    Survey to assess usefulness of web-based educational tool and satisfaction with early education of prematurity.

  3. Parental anxiety.

    Time frame: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.

    Evaluation of parental anxiety associated with prematurity using validated six-item short-form of the Spielberger State-Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory (STAI) measures presence and severity of anxiety. The inventory consists of two self-reporting subscales that evaluate the current state of anxiety (state anxiety subscale), as well as the propensity towards being anxious (trait anxiety subscale). The range for total score is 20-80, with a higher score indicating greater anxiety. The six-item version of the Spielberger State-Trait Anxiety Inventory (STAI: Y-6 item) is composed of three-questions from the original state anxiety subscale and three-questions from the original trait anxiety subscale. This shortened six-item inventory is a reliable and valid instrument when compared to the full forty-question inventory.

Secondary outcomes

  1. Maternal compliance with maternal-fetal medicine provider follow up.

    Time frame: Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.

    Frequency of no show and cancelled appointments during remainder of pregnancy.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Rainbow Babies and Children's Hospital

Registry information

Official study title

Early Education of Prematurity in High Risk Pregnancies-A Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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