Prematurity Education in High Risk Pregnancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03772080|
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prematurity High Risk Pregnancy||Other: Early counseling of prematurity in high-risk pregnancies.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Education of Prematurity in High Risk Pregnancies-A Pilot Study|
|Actual Study Start Date :||November 5, 2018|
|Actual Primary Completion Date :||December 3, 2019|
|Actual Study Completion Date :||March 9, 2020|
|Experimental: Early counseling of prematurity in high-risk pregnancies||
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.
|No Intervention: Standard counseling of prematurity in high-risk pregnancies|
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772080
|United States, Ohio|
|UH Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Rebecca A Fish, MD||UH Cleveland Medical Center|