PrematurityNCT03772080
Prematurity Education in High Risk Pregnancies
A study testing Early counseling of prematurity in high-risk pregnancies. in people with Prematurity and High Risk Pregnancy, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prematurity, High Risk Pregnancy
- What is being tested?
- Early counseling of prematurity in high-risk pregnancies.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prematurity, High Risk Pregnancy
- Being tested
- Early counseling of prematurity in high-risk pregnancies.
- Keywords
- Antenatal Counseling, Education
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early counseling of prematurity in high-risk pregnancies.Other
Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.
| Study group | Role | What they receive |
|---|---|---|
| Early counseling of prematurity in high-risk pregnancies | Experimental | Not described Receives: Other: Early counseling of prematurity in high-risk pregnancies. |
| Standard counseling of prematurity in high-risk pregnancies | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental knowledge of prematurity.
Questionnaire to assess parental knowledge regarding basic concepts of prematurity, associated complications and factors that improve survival.
Measured: 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.
Measured: 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.
Measured: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
Secondary outcomes (1)
Maternal compliance with maternal-fetal medicine provider follow up.
Frequency of no show and cancelled appointments during remainder of pregnancy.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start5 Nov 2018
- Primary completion3 Dec 2019
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rainbow Babies and Children's Hospital
- Responsible party
- Principal investigator, Rebecca Fish, University Hospitals Cleveland Medical Center
- Investigators
- Rebecca A Fish, MD, Principal investigator, UH, Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772080
- Sponsor's protocol ID
- STUDY20180789
- Status last verified
- Jun 2020
- First submitted
- 1 Nov 2018
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Education of Prematurity in High Risk Pregnancies-A Pilot Study
- ClinicalTrials.gov ID
- NCT03772080
- Acronym / sponsor ID
- STUDY20180789
- Conditions
- Prematurity, High Risk Pregnancy
- Keywords
- Antenatal Counseling, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Rainbow Babies and Children's Hospital
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early counseling of prematurity in high-risk pregnancies | Experimental | Other: Early counseling of prematurity in high-risk pregnancies. |
| Standard counseling of prematurity in high-risk pregnancies | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women between 22 0/7 and 34 6/7 weeks gestational age 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Early counseling of prematurity in high-risk pregnancies |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca A Fish, MD principal investigator
UH, Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early counseling of prematurity in high-risk pregnancies. in people with Prematurity and High Risk Pregnancy, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.