Prematurity Education in High Risk Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2020-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prematurity Risk Assessment Combined With Clinical Interventions for Improving Neonatal outcoMEs

NCT04301518

Preterm Labor Preterm Birth

ACTIVE_NOT_RECRUITING NA

Parent Training for Parents of Toddlers Born Very Premature:

NCT05217615

Parenting Problem Behavior Premature Birth +1 more

ACTIVE_NOT_RECRUITING NA

Educational/Behavioral Intervention Program for Parents of Premature Infants

NCT00120614

Premature Birth

COMPLETED NA

Decision Aid - Extreme Prematurity

NCT01713894

Prematurity; Decision Support

COMPLETED NA

Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information

NCT01418950

Premature Birth

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prematurity High Risk Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early counseling of prematurity in high-risk pregnancies

Group Type EXPERIMENTAL

Early counseling of prematurity in high-risk pregnancies.

Intervention Type OTHER

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

Standard counseling of prematurity in high-risk pregnancies

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes