Prematurity Education in High Risk Pregnancies

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772080
• Other study ID #: STUDY20180789
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: March 9, 2020

Study information

• Verified date: June 2020
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 9, 2020
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High Risk Pregnancy
• Premature Birth
• Prematurity

Intervention

Other:
• Early counseling of prematurity in high-risk pregnancies.
Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.

Locations

Country	Name	City	State
United States	UH Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Rainbow Babies and Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Maternal compliance with maternal-fetal medicine provider follow up.	Frequency of no show and cancelled appointments during remainder of pregnancy.	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.