Prematurity Education in High Risk Pregnancies

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

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; High Risk Pregnancy
• Intervention / Treatment: Other: Early counseling of prematurity in high-risk pregnancies.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Rainbow Babies and Children's Hospital
• Investigators: Principal Investigator: Rebecca A Fish, MD, UH, Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: November 1, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Education; Antenatal Counseling
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: STUDY20180789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No