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Prematurity Education in High Risk Pregnancies

Primary Purpose

Prematurity, High Risk Pregnancy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Early counseling of prematurity in high-risk pregnancies.

About this trial

This is an interventional other trial for Prematurity focused on measuring Antenatal Counseling, Education

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.
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.

Sites / Locations

UH Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early counseling of prematurity in high-risk pregnancies

Standard counseling of prematurity in high-risk pregnancies

Arm Description

Outcomes

Primary Outcome Measures

Parental knowledge of prematurity.

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

Parental satisfaction with prematurity education.

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

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.

Secondary Outcome Measures

Maternal compliance with maternal-fetal medicine provider follow up.

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

Full Information

NCT ID

NCT03772080

First Posted

November 1, 2018

Last Updated

June 3, 2020

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Rainbow Babies and Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03772080

Brief Title

Prematurity Education in High Risk Pregnancies

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

November 5, 2018 (Actual)

Primary Completion Date

December 3, 2019 (Actual)

Study Completion Date

March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Rainbow Babies and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity, High Risk Pregnancy

Keywords

Antenatal Counseling, Education

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early counseling of prematurity in high-risk pregnancies

Arm Type

Experimental

Arm Title

Standard counseling of prematurity in high-risk pregnancies

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Early counseling of prematurity in high-risk pregnancies.

Intervention Description

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

Primary Outcome Measure Information:

Title

Parental knowledge of prematurity.

Description

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

Time Frame

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

Title

Parental satisfaction with prematurity education.

Description

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

Title

Parental anxiety.

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Maternal compliance with maternal-fetal medicine provider follow up.

Description

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

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rebecca A Fish, MD

Organizational Affiliation

UH, Cleveland Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prematurity Education in High Risk Pregnancies

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