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Prematurity Education in High Risk Pregnancies

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ClinicalTrials.gov Identifier: NCT03772080
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Rainbow Babies and Children's Hospital
Information provided by (Responsible Party):
Rebecca Fish, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Prematurity High Risk Pregnancy Other: Early counseling of prematurity in high-risk pregnancies. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Early Education of Prematurity in High Risk Pregnancies—A Pilot Study
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Beth Hagesfeld 216-844-1529 Beth.Hagesfeld@UHhospitals.org
Contact: Kirsten Boes 216-286-9478 Kirsten.Boes@UHhospitals.org

Locations
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United States, Ohio
UH Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Rainbow Babies and Children's Hospital
Investigators
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Principal Investigator: Rebecca A Fish, MD UH Cleveland Medical Center

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Responsible Party: Rebecca Fish, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT03772080     History of Changes
Other Study ID Numbers: STUDY20180789
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebecca Fish, University Hospitals Cleveland Medical Center:
Antenatal Counseling
Education

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications