Premature BirthNCT01418950
Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information
A study testing Written information and verbal counseling in people with Premature Birth, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Written information and verbal counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 2012
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking pregnant women who are between 23-34 weeks of gestation
- Who are 18 years and older
- Open to all ethnic groups.
- Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.
Who cannot join
- Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.
- Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.
- If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information
Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.
- Conditions
- Premature Birth
- Being tested
- Written information and verbal counseling
- Keywords
- Prematurity Counseling for pregnant women and their family
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written information and verbal counselingOther
control group will only receive verbal counseling. Study group will receive written information before verbal counseling
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will receive standard verbal counseling regarding outcome of premature infants Receives: Other: Written information and verbal counseling |
| Study Group | Experimental | Study Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants. Receives: Other: Written information and verbal counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.
The knowledge questionnaire consists of questions regarding gestational age specific common potential problems and complications of premature infants. We will score each questionniare and then compare number of correct answers.
Measured: Within 24 hours of counseling the primary outcome will be assessed
Secondary outcomes (1)
The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups
State Trait anxiety Inventory has been used in many studies
Measured: The pre-counseling anxiety score will be obtained immediately after consent is obtained for the study. The post-counseling anxiety score will be obtained within 24 hours of counseling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startApr 2009
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mir Basir, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418950
- Sponsor's protocol ID
- PRO00010267
- Status last verified
- Dec 2013
- First submitted
- 26 Jul 2010
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
PubMed 22492766
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information
- ClinicalTrials.gov ID
- NCT01418950
- Acronym / sponsor ID
- PRO00010267
- Conditions
- Premature Birth
- Keywords
- Prematurity Counseling for pregnant women and their family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Aug 2011 (estimated)
- 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.
Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Written information and verbal counselingThe control group will receive standard verbal counseling regarding outcome of premature infants |
| Study Group | Experimental | Other: Written information and verbal counselingStudy Group will receive gestational age specific written information prior to receiving standard verbal counseling about outcome of premature infants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking pregnant women who are between 23-34 weeks of gestation
- Who are 18 years and older
- Open to all ethnic groups.
- Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.
Key exclusion criteria (3 listed)
- Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.
- Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.
- If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.
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 |
|---|---|---|
| Written information and verbal counselingcontrol group will only receive verbal counseling. Study group will receive written information before verbal counseling | Other | Control group, Study Group |
Primary outcome
Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.
Time frame: Within 24 hours of counseling the primary outcome will be assessed
The knowledge questionnaire consists of questions regarding gestational age specific common potential problems and complications of premature infants. We will score each questionniare and then compare number of correct answers.
1 secondary outcome
The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups
Time frame: The pre-counseling anxiety score will be obtained immediately after consent is obtained for the study. The post-counseling anxiety score will be obtained within 24 hours of counseling
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 18 Dec 2013.
- Derived from this study: PubMed 22492766Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
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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.
Mir Basir, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written information and verbal counseling in people with Premature Birth, run by Medical College of Wisconsin 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 4 inclusion and 3 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 18 Dec 2013. 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?
Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups. (time frame: Within 24 hours of counseling the primary outcome will be assessed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418950, which also lists 1 linked publication.
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 18 Dec 2013.