Prematurity Education in High Risk Pregnancies

NCT03772080 | Completed

• 1 other identifier: STUDY20180789
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prematurity; High Risk Pregnancy

Keywords

Antenatal Counseling; Education

Outcome Measures

Primary Outcomes (3)

• Parental knowledge of prematurity.

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

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

• Parental satisfaction with prematurity education.

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

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

• Parental anxiety.

  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.

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

Secondary Outcomes (1)

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

  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.

Study Arms (2)

Early counseling of prematurity in high-risk pregnancies

EXPERIMENTAL

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

Standard counseling of prematurity in high-risk pregnancies

NO INTERVENTION

Interventions

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.

Early counseling of prematurity in high-risk pregnancies

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Rainbow Babies and Children's Hospital: collaborator

Study Sites (1)

UH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Pregnancy, High-Risk

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Rebecca A Fish, MD

  UH, Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 11, 2018
• Study Start: November 5, 2018
• Primary Completion: December 3, 2019
• Study Completion: March 9, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)